Arm Boot Camp Study: Evaluation of a Program to Increase Upper Limb Recovery After Stroke

Sponsor
University of British Columbia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04232163
Collaborator
(none)
64
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2
32.5
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Study Details

Study Description

Brief Summary

This study will examine the feasibility and effect of a program that combines exercise and feedback from a wearable device on upper limb movement practice and function in individuals with stroke.

Detailed Description

Participants will be randomized into either the Immediate Treatment Group or the Delayed Treatment group. Both groups will complete the same intervention program. The Immediate treatment group will start the program right away while the Delayed Treatment group will start the program after a 3 week delay. The intervention program is 3 weeks in duration and consists of participants completing at least two hours of exercises (adapted from the Home-GRASP program) daily and wearing an activity monitor on their affected wrist during waking hours for the duration of the intervention. Participants will be asked to meet daily movement count goals based on information from the monitor. Participants will have 6 virtual sessions with a therapist who will teach and monitor exercises thru an online platform (Zoom Video Communications), work with participants to generate and progress daily movement goals and discuss barriers and potential solutions to exercise adherence and/or meeting movement goals.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of a Program to Increase Upper Limb Recovery After Stroke
Actual Study Start Date :
Aug 15, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Immediate Treatment Group

Participants will receive the intervention right away

Behavioral: Arm Boot Camp
The intervention involves a combination of daily homework based upper limb exercises and feedback from an activity monitor to motivate use of the affected upper limb. Participants will be supported through virtual sessions with a therapist.

No Intervention: Delayed Treatment Group

Participants will receive usual care (no intervention), however, they will receive the intervention after a 3 week delay

Outcome Measures

Primary Outcome Measures

  1. Hand counts captured using an activity monitor [Post intervention (immediately following 3 weeks of intervention)]

    Participants wear the activity monitor on stroke affected arm during waking hours for 3 consecutive days

Secondary Outcome Measures

  1. ArmCAM (Arm Capacity and Movement Test) [Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention)]

    The online upper extremity functional assessment consists of 10 items that measure gross movements, supported reach, functional reach and grasp movements, functional wrist movement, and fine motor skills.

  2. Stroke Impact Scale - hand and strength scales [Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention)]

    Evaluate how stroke has impacted health and life

  3. Hand count measured during the intervention sessions [Daily counts within 3 week intervention]

    Daily hand count data captured using activity monitor on the stroke affected arm during intervention period

  4. REACH Scale [Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention)]

    A self-report measure for individuals with stroke that captures how the affected arm and hand is being used outside of the clinical setting.

  5. Hand counts captured using an activity monitor [Follow up (two months after completion of intervention)]

    Participants wear the activity monitor on stroke affected arm during waking hours for 3 consecutive days

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 19 years or older

  • < 1 year since the stroke occurred

  • Living in the community

  • Have unilateral upper limb impairment

  • Have some ability to move their arm and hand (> 30° shoulder flexion or abduction and Fugl Meyer finger extension score > 0)

  • Are using their affected upper limb in a different way than prior to their stroke (REACH score < 4)

  • Completed formal physical and occupational therapy rehabilitation for the upper limb

  • Have access to a tablet, computer, laptop or phone with internet and email access.

NOTE: If participant have a caregiver, we would like to invite him/her to assist in this study; however, a caregiver is not a must for participating in this study.

Exclusion Criteria:
  • musculoskeletal/other neurological conditions that limit movement in their arm

  • unable to provide informed consent

  • have another medical condition that would affect their ability to participate in the treatment protocol

  • have persistent pain in their affected upper limb that affects their ability to use the limb

  • Unable to speak, understand, or read English (unless another person, [i.e., family member, care taker or friend] can be present and translate during measurement/treatment sessions, and home activities related to the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Calgary Calgary Alberta Canada T2N 2T9
2 GF Strong Rehab Centre Vancouver British Columbia Canada V5Z 2G9
3 Riverview Health Centre Winnipeg Manitoba Canada R3L 2P4
4 Dalhousie University Halifax Nova Scotia Canada B3H 3J5
5 Parkwood Institute London Ontario Canada B3H 3J5
6 Toronto Rehabilitation Institute - University Health Network Toronto Ontario Canada Evan.Foster@uhn.ca
7 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5

Sponsors and Collaborators

  • University of British Columbia

Investigators

  • Principal Investigator: Janice Eng, PhD, University of British Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Janice Eng, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier:
NCT04232163
Other Study ID Numbers:
  • H19-02005
First Posted:
Jan 18, 2020
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Janice Eng, Principal Investigator, University of British Columbia
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2022