Altering Activation Patterns Post-stroke

Sponsor
Shirley Ryan AbilityLab (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02418949
Collaborator
National Institutes of Health (NIH) (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
96
Enrollment
1
Location
4
Arms
83
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates a new rehabilitation approach for stroke survivors in the chronic phase of recovery in which the combination of drug therapy (cyproheptadine) and active movement practice (AMP) is used to encourage increased voluntary muscle control and strength.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Cyproheptadine
  • Drug: Placebo for Cyproheptadine
  • Other: Active Movement Practice (AMP)
  • Other: Passive Cyclical Stretching
N/A

Detailed Description

In this four arm parallel design you will be randomly assigned to one of 4 groups:

Group 1) cyproheptadine and active movement therapy, Group 2) placebo and active movement therapy, Group 3) cyproheptadine and passive stretching, or Group 4) placebo and passive stretching.

The groups will be blinded so neither you nor the research staff (or even the study doctor) will know which drug (Cyproheptadine or placebo) you receive. Only the RIC pharmacist will have access to this information until all participants complete the entire study. Although you and the research staff administering the training sessions will know if you have been assigned to the active movement practice (AMP) or passive cyclical stretching group, it is important not to discuss this information with the rater (evaluator) or the study doctor.

Cyproheptadine is an anti-serotonergic and anti spastic agent. It is expected to reduce the unwanted muscle hyper excitability (one measure of spasticity) common after stroke.

During the course of the treatment you will be required to make several visits per week to RIC to either be evaluated or participate in the treatment sessions. Evaluations last approximately 2 hours and will be performed at the beginning of weeks 1, 2, 3 and 4, during the middle of treatment (beginning of week 7), at the end of training (beginning of week 10) as well as a final follow-up visit one month after the end of treatment (beginning of week 14). The training sessions will occur from weeks 4 through week 9 and will involve 1.5-hr. sessions (1 hr training plus setup time) 3 times per week.

The investigators hypothesize that the group receiving the combined cyproheptadine and active movement therapy will have better outcomes than the groups receiving cyproheptadine or active movement therapy alone.

Study Design

Study Type:
Interventional
Actual Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Altering Activation Patterns in the Distal Upper Extremity After Stroke
Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Aug 1, 2019
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Cyproheptadine + AMP

Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.

Drug: Cyproheptadine
Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
Other Names:
  • cyproheptadine hydrochloride USP
  • cyproheptadine HCl
  • Periactin
  • Other: Active Movement Practice (AMP)
    Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.

    Placebo Comparator: Placebo for Cyproheptadine + Stretching

    Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest. Dose will be titrated down to zero in the 2 weeks following treatment.

    Drug: Placebo for Cyproheptadine
    Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
    Other Names:
  • placebo
  • Other: Passive Cyclical Stretching
    Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.

    Active Comparator: Cyproheptadine + Stretching

    Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest. Dose will be titrated down to zero in the 2 weeks following treatment.

    Drug: Cyproheptadine
    Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
    Other Names:
  • cyproheptadine hydrochloride USP
  • cyproheptadine HCl
  • Periactin
  • Other: Passive Cyclical Stretching
    Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.

    Active Comparator: Placebo for Cyproheptadine + AMP

    Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.

    Drug: Placebo for Cyproheptadine
    Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug
    Other Names:
  • placebo
  • Other: Active Movement Practice (AMP)
    Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.

    Outcome Measures

    Primary Outcome Measures

    1. Change in Mean Completion Time for Graded Wolf Motor Function Test (GWMFT) [baseline and 9 weeks (immediately post intervention)]

      GWMFT is a clinical outcome measure comprised of 15 timed tasks focusing on upper extremity function. Maximum allowable time per task is 120 seconds.

    Secondary Outcome Measures

    1. Change in Grip Relaxation Time (Following a Maximum Voluntary Contraction (MVC) [baseline and 9 weeks (immediately post intervention)]

      Following a maximum voluntary contraction (MVC) -- Time (s) required for muscle electromyographic (EMG) signals to reduce to within 3 SD of pre-MVC EMG activity.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Chronic, severe hand hemiparesis resulting from a single stroke (Chedoke- McMaster Stroke Assessment: Stage of Hand 2 or 3)

    • Single stroke occurring at least 6 months prior to enrollment

    • Spasticity

    • Capacity to provide informed consent

    Exclusion Criteria:
    • Excessive pain in paretic upper limb

    • Hemispatial neglect (as assessed by the Behavioral Inattention Test)

    • Apraxia (as assessed by the FABERS battery)

    • Botulinum toxin injection in the upper extremity within the past 6 months

    • Introduction of new anti-spasticity medication within the past 6 months

    • Orthopaedic impairments

    • History of seizure disorder

    • Other major health impairment

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Rehabilitation Institute of ChicagoChicagoIllinoisUnited States60611

    Sponsors and Collaborators

    • Shirley Ryan AbilityLab
    • National Institutes of Health (NIH)
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    Investigators

    • Study Director: Derek G Kamper, PhD, North Carolina State University
    • Principal Investigator: Elliot Roth, MD, Shirley Ryan AbilityLab

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Elliot Roth, Medical Director, Patient Recovery Unit, Attending Physician, RIC Professor & Chairman, PM&R, Northwestern Feinberg School of Medicine, Shirley Ryan AbilityLab
    ClinicalTrials.gov Identifier:
    NCT02418949
    Other Study ID Numbers:
    • STU00078099
    • 1R01HD075813-01A1
    First Posted:
    Apr 17, 2015
    Last Update Posted:
    Jul 13, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Elliot Roth, Medical Director, Patient Recovery Unit, Attending Physician, RIC Professor & Chairman, PM&R, Northwestern Feinberg School of Medicine, Shirley Ryan AbilityLab
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleCyproheptadine + AMPPlacebo for Cyproheptadine + StretchingCyproheptadine + StretchingPlacebo for Cyproheptadine + AMP
    Arm/Group DescriptionCyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment. Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest. Dose will be titrated down to zero in the 2 weeks following treatment. Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest. Dose will be titrated down to zero in the 2 weeks following treatment. Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment. Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.
    Period Title: Overall Study
    STARTED23222625
    COMPLETED20212324
    NOT COMPLETED3131

    Baseline Characteristics

    Arm/Group TitleCyproheptadine + AMPPlacebo for Cyproheptadine + StretchingCyproheptadine + StretchingPlacebo for Cyproheptadine + AMPTotal
    Arm/Group DescriptionCyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment. Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest. Dose will be titrated down to zero in the 2 weeks following treatment. Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest. Dose will be titrated down to zero in the 2 weeks following treatment. Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment. Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.Total of all reporting groups
    Overall Participants2222252594
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    60
    (8.1)
    57.1
    (11.2)
    58.9
    (13.1)
    57.3
    (9.5)
    58.3
    (10.6)
    Sex: Female, Male (Count of Participants)
    Female
    8
    36.4%
    9
    40.9%
    10
    40%
    8
    32%
    35
    37.2%
    Male
    14
    63.6%
    13
    59.1%
    15
    60%
    17
    68%
    59
    62.8%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    1
    4.5%
    21
    95.5%
    23
    92%
    23
    92%
    68
    72.3%
    Not Hispanic or Latino
    21
    95.5%
    1
    4.5%
    2
    8%
    2
    8%
    26
    27.7%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    3
    13.6%
    0
    0%
    2
    8%
    1
    4%
    6
    6.4%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    11
    50%
    9
    40.9%
    12
    48%
    13
    52%
    45
    47.9%
    White
    8
    36.4%
    13
    59.1%
    11
    44%
    11
    44%
    43
    45.7%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Chedoke McMaster Scale of Hand (Count of Participants)
    Equal or less than 2
    6
    27.3%
    11
    50%
    6
    24%
    8
    32%
    31
    33%
    Equal or Greater than 3
    16
    72.7%
    11
    50%
    19
    76%
    17
    68%
    63
    67%
    Fugl-Meyer Upper Extremity Assessment (Score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Score]
    15
    (8.1)
    12.9
    (5.5)
    16.1
    (7.1)
    15.6
    (5.6)
    15
    (6.6)
    Lesion Side (Count of Participants)
    Left
    10
    45.5%
    7
    31.8%
    11
    44%
    12
    48%
    40
    42.6%
    Right
    12
    54.5%
    15
    68.2%
    14
    56%
    13
    52%
    54
    57.4%
    Time Since Stroke onset (Years) (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    5.9
    (4.3)
    5.4
    (5.3)
    5.6
    (4.7)
    8.5
    (8.6)
    6.4
    (6.0)

    Outcome Measures

    1. Primary Outcome
    TitleChange in Mean Completion Time for Graded Wolf Motor Function Test (GWMFT)
    DescriptionGWMFT is a clinical outcome measure comprised of 15 timed tasks focusing on upper extremity function. Maximum allowable time per task is 120 seconds.
    Time Framebaseline and 9 weeks (immediately post intervention)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleCyproheptadine + AMPPlacebo for Cyproheptadine + StretchingCyproheptadine + StretchingPlacebo for Cyproheptadine + AMP
    Arm/Group DescriptionCyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment. Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest. Dose will be titrated down to zero in the 2 weeks following treatment. Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest. Dose will be titrated down to zero in the 2 weeks following treatment. Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment. Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.
    Measure Participants20212324
    Mean (95% Confidence Interval) [Seconds]
    -3.66
    -0.51
    -4.00
    -3.89
    2. Secondary Outcome
    TitleChange in Grip Relaxation Time (Following a Maximum Voluntary Contraction (MVC)
    DescriptionFollowing a maximum voluntary contraction (MVC) -- Time (s) required for muscle electromyographic (EMG) signals to reduce to within 3 SD of pre-MVC EMG activity.
    Time Framebaseline and 9 weeks (immediately post intervention)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleCyproheptadine + AMPPlacebo for Cyproheptadine + StretchingCyproheptadine + StretchingPlacebo for Cyproheptadine + AMP
    Arm/Group DescriptionCyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment. Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest. Dose will be titrated down to zero in the 2 weeks following treatment. Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest. Dose will be titrated down to zero in the 2 weeks following treatment. Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment. Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.
    Measure Participants20212324
    Mean (95% Confidence Interval) [Seconds]
    -1.66
    -0.96
    -1.06
    -2.65

    Adverse Events

    Time FrameAdverse events were collected during study enrollment, from screening to the final follow up appointment (13 total weeks after initial screening)
    Adverse Event Reporting Description
    Arm/Group TitleCyproheptadine + AMPPlacebo for Cyproheptadine + StretchingCyproheptadine + StretchingPlacebo for Cyproheptadine + AMP
    Arm/Group DescriptionCyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment. Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest. Dose will be titrated down to zero in the 2 weeks following treatment. Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest. Dose will be titrated down to zero in the 2 weeks following treatment. Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug Passive Cyclical Stretching: Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment. Placebo for Cyproheptadine: Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug Active Movement Practice (AMP): Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.
    All Cause Mortality
    Cyproheptadine + AMPPlacebo for Cyproheptadine + StretchingCyproheptadine + StretchingPlacebo for Cyproheptadine + AMP
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/23 (0%) 0/22 (0%) 0/26 (0%) 0/25 (0%)
    Serious Adverse Events
    Cyproheptadine + AMPPlacebo for Cyproheptadine + StretchingCyproheptadine + StretchingPlacebo for Cyproheptadine + AMP
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total2/23 (8.7%) 2/22 (9.1%) 1/26 (3.8%) 0/25 (0%)
    Cardiac disorders
    CHF Exacerbation0/23 (0%) 00/22 (0%) 01/26 (3.8%) 10/25 (0%) 0
    Coronary Blockage0/23 (0%) 01/22 (4.5%) 10/26 (0%) 00/25 (0%) 0
    Gastrointestinal disorders
    Bowel Obstruction1/23 (4.3%) 10/22 (0%) 00/26 (0%) 00/25 (0%) 0
    Nervous system disorders
    Convulsions0/23 (0%) 01/22 (4.5%) 10/26 (0%) 00/25 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia1/23 (4.3%) 10/22 (0%) 00/26 (0%) 00/25 (0%) 0
    Skin and subcutaneous tissue disorders
    Foot Wound1/23 (4.3%) 10/22 (0%) 00/26 (0%) 00/25 (0%) 0
    Other (Not Including Serious) Adverse Events
    Cyproheptadine + AMPPlacebo for Cyproheptadine + StretchingCyproheptadine + StretchingPlacebo for Cyproheptadine + AMP
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total19/23 (82.6%) 15/22 (68.2%) 18/26 (69.2%) 21/25 (84%)
    Gastrointestinal disorders
    Constipation6/23 (26.1%) 65/22 (22.7%) 56/26 (23.1%) 66/25 (24%) 6
    General disorders
    Dry Mouth9/23 (39.1%) 99/22 (40.9%) 911/26 (42.3%) 119/25 (36%) 9
    Low Energy10/23 (43.5%) 107/22 (31.8%) 712/26 (46.2%) 124/25 (16%) 4
    Restless/Jittery4/23 (17.4%) 43/22 (13.6%) 34/26 (15.4%) 43/25 (12%) 3
    Slowness/Trouble getting moving3/23 (13%) 36/22 (27.3%) 67/26 (26.9%) 75/25 (20%) 5
    Sleep Problems3/23 (13%) 34/22 (18.2%) 45/26 (19.2%) 55/25 (20%) 5
    Memory Problems2/23 (8.7%) 28/22 (36.4%) 89/26 (34.6%) 94/25 (16%) 4
    Metabolism and nutrition disorders
    Weight Gain7/23 (30.4%) 76/22 (27.3%) 69/26 (34.6%) 95/25 (20%) 5
    Psychiatric disorders
    Low Motivation1/23 (4.3%) 15/22 (22.7%) 59/26 (34.6%) 92/25 (8%) 2
    Renal and urinary disorders
    Frequent Urination7/23 (30.4%) 76/22 (27.3%) 67/26 (26.9%) 74/25 (16%) 4
    Difficulty Urinating4/23 (17.4%) 42/22 (9.1%) 22/26 (7.7%) 22/25 (8%) 2

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleAlexander Barry
    OrganizationShirley Ryan AbilityLab
    Phone3122381435
    Emailabarry@sralab.org
    Responsible Party:
    Elliot Roth, Medical Director, Patient Recovery Unit, Attending Physician, RIC Professor & Chairman, PM&R, Northwestern Feinberg School of Medicine, Shirley Ryan AbilityLab
    ClinicalTrials.gov Identifier:
    NCT02418949
    Other Study ID Numbers:
    • STU00078099
    • 1R01HD075813-01A1
    First Posted:
    Apr 17, 2015
    Last Update Posted:
    Jul 13, 2021
    Last Verified:
    Jul 1, 2021