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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of a Program to Increase Upper Limb Recovery After Stroke

Conditions
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Stroke, Cerebral Infarction, Brain Diseases, Central Nervous System Diseases, Cerebrovascular Disorders, Brain Ischemia, Brain Infarction, Vascular Diseases, Infarction, Nervous System Diseases, Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: Arm Boot Camp


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Treatment Group<br>Participants will receive the intervention right away | Behavioral: Arm Boot Camp<br>* 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.<br>|
| No Intervention: Delayed Treatment Group<br>Participants will receive usual care (no intervention), however, they will receive the intervention after a 3 week delay | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand counts captured using an activity monitor | 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) | 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 | 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 | Daily hand count data captured using activity monitor on the stroke affected arm during intervention period | Daily counts within 3 week intervention | 
| REACH Scale | 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 | Participants wear the activity monitor on stroke affected arm during waking hours for 3 consecutive days | Follow up (two months after completion of intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Upper extremity, Rehabilitation, Wearable device, Exercise, Randomized Controlled Trial