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

May 20, 2022 updated by: Janice Eng, University of British Columbia

Evaluation of a Program to Increase Upper Limb Recovery After Stroke

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Recruiting
        • University of Calgary
        • Contact:
        • Sub-Investigator:
          • Sean Dukelow, MD
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 2G9
        • Recruiting
        • GF Strong Rehab Centre
        • Contact:
        • Principal Investigator:
          • Janice Eng, PhD
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3L 2P4
        • Recruiting
        • Riverview Health Centre
        • Contact:
        • Sub-Investigator:
          • Ruth Barclay, PhD
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3J5
        • Recruiting
        • Dalhousie University
        • Contact:
        • Sub-Investigator:
          • Marilyn Mackay-Lyons, PhD
    • Ontario
      • London, Ontario, Canada, B3H 3J5
        • Recruiting
        • Parkwood Institute
        • Contact:
        • Sub-Investigator:
          • Robert Teasell, MD
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
        • Sub-Investigator:
          • Bradley MacIntosh, PhD
      • Toronto, Ontario, Canada, Evan.Foster@uhn.ca
        • Recruiting
        • Toronto Rehabilitation Institute - University Health Network
        • Contact:
        • Sub-Investigator:
          • Mark Bailey, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand counts captured using an activity monitor
Time Frame: Post intervention (immediately following 3 weeks of intervention)
Participants wear the activity monitor on stroke affected arm during waking hours for 3 consecutive days
Post intervention (immediately following 3 weeks of intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ArmCAM (Arm Capacity and Movement Test)
Time Frame: 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.
Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention)
Stroke Impact Scale - hand and strength scales
Time Frame: Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention)
Evaluate how stroke has impacted health and life
Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention)
Hand count measured during the intervention sessions
Time Frame: Daily counts within 3 week intervention
Daily hand count data captured using activity monitor on the stroke affected arm during intervention period
Daily counts within 3 week intervention
REACH Scale
Time Frame: 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.
Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention)
Hand counts captured using an activity monitor
Time Frame: Follow up (two months after completion of intervention)
Participants wear the activity monitor on stroke affected arm during waking hours for 3 consecutive days
Follow up (two months after completion of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

December 23, 2019

First Submitted That Met QC Criteria

January 14, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 20, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H19-02005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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