Post Stroke Hand Functions: Bilateral Movements and Electrical Stimulation Treatments

Sponsor
University of Florida (Other)
Overall Status
Completed
CT.gov ID
NCT00369668
Collaborator
(none)
30
1
3
34
0.9

Study Details

Study Description

Brief Summary

The purpose of this study was to determine the effect of two amounts of treatment therapy on post stroke motor recovery in the arms. The therapy is bilateral movement training combined with electrical stimulation on the impaired limb.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Bilateral movements and neuromuscular electrical stimulation
  • Behavioral: Bilateral movements and neuromuscular electrical stimulation
  • Behavioral: Bilateral movements and sham electrical stimulation
Phase 2

Detailed Description

Intense movement training (practice) with the affected arm after stroke has the potential to improve upper extremity (UE) function resulting from neuroplasticity changes in the motor cortex. However, the necessary and sufficient parameters of this therapy in humans have not been fully investigated. Delineation of the most efficacious and efficient therapy for promoting UE recovery post-stroke is necessary before effective clinical implementation of this therapy. The current compared the effects on motor function impairments for three bilateral movement groups involving two doses of treatment (i.e., bilateral training coupled with neuromuscular electrical stimulation) and a sham control. During the subacute recovery phase (3 - 6 months), patients who meet motor capabilities criteria will be randomly assigned to one of three groups: (a) low intensity: 90 minutes/session, 2 sessions/week 2 weeks; bilateral movement training coupled with active neuromuscular stimulation on the impaired wrist/fingers; (b) high intensity: 90 minutes/session, 4 sessions/week for 2 weeks; bilateral movement training coupled with active stimulation on the impaired wrist/finger extensors; and (c) control group (sham active stimulation). Patients' UE motor capabilities were assessed before treatment therapy began (pretest) and within the first week after the treatment therapy ended (posttest).

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Subacute Stroke Recovery (Upper Extremity Motor Function): Bimanual Coordination Training
Study Start Date :
Aug 1, 2006
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: High Intensity

Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.

Behavioral: Bilateral movements and neuromuscular electrical stimulation
Participants practice moving their paretic arm at the same time as they move their non-paretic arm in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the movements. Training period was 4 times per week for 2 weeks.
Other Names:
  • functional electrical stimulation
  • Active Comparator: Low Intensity

    Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.

    Behavioral: Bilateral movements and neuromuscular electrical stimulation
    Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the movements. Training period was 2 times per week for 2 weeks.
    Other Names:
  • functional electrical stimulation
  • Active Comparator: Control

    Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation

    Behavioral: Bilateral movements and sham electrical stimulation
    Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Sham electrical stimulation (low level electrical stimulation that can be felt but is insufficient to trigger a muscle contraction) is provided to the paretic arm during the movement. Training period was 2 times per week for 2 weeks.
    Other Names:
  • functional electrical stimulation - sham
  • Outcome Measures

    Primary Outcome Measures

    1. Box and Block Test; Data Collected = Number of Blocks Moved [Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)]

      A 60 second timed hand/arm manipulation test in which participants reach, grasp, lift, and release a 1" x 1" block of wood. They must lift a block from one side of a box, carry it over a low barrier and release the block into the other side of the box.

    2. Fugl-Meyer Upper Extremity Motor Test [Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)]

      FM motor test assesses functional impairments post stroke as participants attempt various movements from daily activities. Minimum score = 0; maximum score = 66; lower scores indicate more impairments and higher scores indicate less impairments.

    3. Fractionated Reaction Time [Baseline/pretest; posttest given between days 17-22 (posttest days 3-8)]

      Premotor reaction times in milliseconds were recorded for the impaired arm of each participant in the three intervention (arm) groups. Premotor reaction time represents central processes. Lower times are faster reaction times, indicating less time to initiate a movement.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    44 Years to 86 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • an ability to complete 10º of wrist or finger extension from a 60 - 65 º flexed position

    • score less than a 56 on the UE subscale of the Fugl-Meyer Assessment

    • an ability to voluntarily activate slight movements in the wrist and fingers so that the EMG activity reaches a minimal level on the microprocessor for electrical stimulation to be activated

    • unilateral, first stroke of ischemic or hemorrhagic origin in the carotid artery distribution

    • free of major post stroke complications

    • able to attend therapy 2 days/week or 4 days/week for 2 weeks

    • score at least a 16 on the Mini Mental Status Examination

    • able to discriminate sharp from dull and light touch using traditional sensation tests.

    Exclusion Criteria:
    • hemiparetic arm is insensate

    • motor impairments from stroke on opposite side of body

    • pre-existing neurological disorders such as Parkinson's disease, Multiple Sclerosis, or dementia

    • Legal blindness or severe visual impairment; 5) Life expectancy less than one year

    • Severe arthritis or orthopedic problems that limit passive ranges of motion of upper extremity (passive finger extension < 40º; passive wrist extension < 40º; passive elbow extension <40º; shoulder flexion/abduction < 80º)

    • History of sustained alcoholism or drug abuse in the last six months

    • Has pacemaker or other implanted device

    • pregnant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Motor Behavior Laboratory, University of Florida Gainesville Florida United States 32611

    Sponsors and Collaborators

    • University of Florida

    Investigators

    • Principal Investigator: James H. Cauraugh, Ph.D., University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT00369668
    Other Study ID Numbers:
    • 00061194
    First Posted:
    Aug 29, 2006
    Last Update Posted:
    Jun 15, 2012
    Last Verified:
    Apr 1, 2012
    Keywords provided by University of Florida
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Started August 2006 and ended June 2009
    Pre-assignment Detail Inability to voluntarily execute 10 degrees of wrist/finger extension from a 60-65 degrees flexed position.
    Arm/Group Title High Intensity Low Intensity Control
    Arm/Group Description Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks. Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks. Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.
    Period Title: Overall Study
    STARTED 10 10 10
    COMPLETED 6 5 3
    NOT COMPLETED 4 5 7

    Baseline Characteristics

    Arm/Group Title High Intensity Low Intensity Control Total
    Arm/Group Description Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks. Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks. Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation. Total of all reporting groups
    Overall Participants 10 10 10 30
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    4
    40%
    3
    30%
    5
    50%
    12
    40%
    >=65 years
    6
    60%
    7
    70%
    5
    50%
    18
    60%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    65.3
    (8.1)
    67.2
    (6.8)
    61.8
    (2.6)
    65.2
    (6.6)
    Sex: Female, Male (Count of Participants)
    Female
    6
    60%
    6
    60%
    5
    50%
    17
    56.7%
    Male
    4
    40%
    4
    40%
    5
    50%
    13
    43.3%
    Region of Enrollment (participants) [Number]
    United States
    10
    100%
    10
    100%
    10
    100%
    30
    100%

    Outcome Measures

    1. Primary Outcome
    Title Box and Block Test; Data Collected = Number of Blocks Moved
    Description A 60 second timed hand/arm manipulation test in which participants reach, grasp, lift, and release a 1" x 1" block of wood. They must lift a block from one side of a box, carry it over a low barrier and release the block into the other side of the box.
    Time Frame Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)

    Outcome Measure Data

    Analysis Population Description
    All participants who completed the bilateral training protocols were submitted to statistical analysis. Data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment.
    Arm/Group Title High Intensity Low Intensity Control
    Arm/Group Description Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks. Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks. Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation
    Measure Participants 6 5 3
    Baseline/Pretest
    24.5
    (22.1)
    24.6
    (12.7)
    40
    (27.1)
    Posttest
    27.5
    (21.7)
    31.8
    (12.6)
    42
    (26.5)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection High Intensity, Low Intensity, Control
    Comments Group by Test Session ANOVA with repeated measures on second factor.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments
    Method Mixed Models Analysis
    Comments Greenhouse-Geisser degrees of freedom adjustment was not necessary.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 30
    Confidence Interval (2-Sided) 95%
    22.5 to 37.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.65
    Estimation Comments
    2. Primary Outcome
    Title Fugl-Meyer Upper Extremity Motor Test
    Description FM motor test assesses functional impairments post stroke as participants attempt various movements from daily activities. Minimum score = 0; maximum score = 66; lower scores indicate more impairments and higher scores indicate less impairments.
    Time Frame Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)

    Outcome Measure Data

    Analysis Population Description
    All participants who completed the bilateral training protocols were submitted to statistical analysis. Data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment.
    Arm/Group Title High Intensity Low Intensity Control
    Arm/Group Description Bilateral movements coupled with neuromuscular electrical stimulation. Four times per week for two weeks. Bilateral movements coupled with neuromuscular electrical stimulation. Two times per week for two weeks. Bilateral movements coupled with sham neuromuscular electrical stimulation. Two times per week for two weeks.
    Measure Participants 6 5 3
    Baseline/Pretest
    39
    (19.8)
    41
    (16.3)
    53
    (9.7)
    Posttest
    42
    (17.1)
    45
    (15.6)
    56
    (6.9)
    3. Primary Outcome
    Title Fractionated Reaction Time
    Description Premotor reaction times in milliseconds were recorded for the impaired arm of each participant in the three intervention (arm) groups. Premotor reaction time represents central processes. Lower times are faster reaction times, indicating less time to initiate a movement.
    Time Frame Baseline/pretest; posttest given between days 17-22 (posttest days 3-8)

    Outcome Measure Data

    Analysis Population Description
    All participants who completed the bilateral training protocols were submitted to statistical analysis. Premotor reaction data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment.
    Arm/Group Title High Intensity Low Intensity Control
    Arm/Group Description Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks. Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks. Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation
    Measure Participants 6 5 3
    Baseline/Pretest
    179
    (27.1)
    225
    (19.3)
    135
    (5.6)
    Posttest
    170
    (22.8)
    241
    (23.4)
    161
    (5.4)

    Adverse Events

    Time Frame 2 years, 10 months
    Adverse Event Reporting Description
    Arm/Group Title High Intensity Low Intensity Control
    Arm/Group Description Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks. Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks. Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.
    All Cause Mortality
    High Intensity Low Intensity Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    High Intensity Low Intensity Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/10 (0%) 0/10 (0%) 0/10 (0%)
    Other (Not Including Serious) Adverse Events
    High Intensity Low Intensity Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/10 (0%) 0/10 (0%) 0/10 (0%)

    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/Title James Cauraugh, Ph.D., PI
    Organization University of Florida, Motor Behavior Laboratory
    Phone 352-294-1623
    Email jcaura@hhp.ufl.edu
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT00369668
    Other Study ID Numbers:
    • 00061194
    First Posted:
    Aug 29, 2006
    Last Update Posted:
    Jun 15, 2012
    Last Verified:
    Apr 1, 2012