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

Not Applicable

Completed

• Conditions: Stroke; Central Nervous System Diseases; Cerebrovascular Disorders; Cardiovascular Diseases; Cerebral Infarction; Brain Diseases; Infarction; Brain Infarction; Vascular Diseases; Nervous System Diseases
• Interventions: Behavioral: Arm Boot Camp

• Registration Number: NCT04232163
• Lead Sponsor: University of British Columbia

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-23
• Study First Submitted QC: 2020-01-14
• Study First Posted: 2020-01-18
• Study Start: 2020-08-15
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Treatment Group	Arm Boot Camp	Participants will receive the intervention right away

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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
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
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.
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

Trial Locations

Locations (7)

Dalhousie University; 🇨🇦 Halifax, Nova Scotia, Canada

GF Strong Rehab Centre; 🇨🇦 Vancouver, British Columbia, Canada

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

Parkwood Institute; 🇨🇦 London, Ontario, Canada

Toronto Rehabilitation Institute - University Health Network; 🇨🇦 Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Riverview Health Centre; 🇨🇦 Winnipeg, Manitoba, Canada