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

NCT ID: NCT04232163

Last Updated: 2023-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-15

Study Completion Date

2022-12-31

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.

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Immediate Treatment Group

Participants will receive the intervention right away

Group Type EXPERIMENTAL

Arm Boot Camp

Intervention Type BEHAVIORAL

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.

Delayed Treatment Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Janice Eng

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Janice Eng, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status

GF Strong Rehab Centre

Vancouver, British Columbia, Canada

Site Status

Riverview Health Centre

Winnipeg, Manitoba, Canada

Site Status

Dalhousie University

Halifax, Nova Scotia, Canada

Site Status

Parkwood Institute

London, Ontario, Canada

Site Status

Toronto Rehabilitation Institute - University Health Network

Toronto, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Simpson LA, Mow A, Menon C, Eng JJ. Preliminary Examination of the Ability of a New Wearable Device to Capture Functional Hand Activity After Stroke. Stroke. 2019 Dec;50(12):3643-3646. doi: 10.1161/STROKEAHA.119.026921. Epub 2019 Oct 30.

Reference Type BACKGROUND
PMID: 31662119 (View on PubMed)

Simpson LA, Barclay R, Bayley MT, Brasher PMA, Dukelow SP, MacIntosh BJ, MacKay-Lyons M, Menon C, Mortenson WB, Peng TH, Pollock CL, Pooyania S, Silverberg ND, Teasell R, Yao J, Eng JJ. A Randomized Control Trial of a Virtually Delivered Program for Increasing Upper Limb Activity After Stroke. Neurorehabil Neural Repair. 2025 Mar;39(3):179-189. doi: 10.1177/15459683241303702. Epub 2024 Dec 27.

Reference Type DERIVED
PMID: 39727287 (View on PubMed)

Simpson LA, Barclay R, Bayley MT, Dukelow SP, MacIntosh BJ, MacKay-Lyons M, Menon C, Mortenson WB, Peng TH, Pollock CL, Pooyania S, Teasell R, Yang CL, Yao J, Eng JJ. Virtual Arm Boot Camp (V-ABC): study protocol for a mixed-methods study to increase upper limb recovery after stroke with an intensive program coupled with a grasp count device. Trials. 2022 Feb 8;23(1):129. doi: 10.1186/s13063-022-06047-9.

Reference Type DERIVED
PMID: 35135585 (View on PubMed)

Other Identifiers

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H19-02005

Identifier Type: -

Identifier Source: org_study_id

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