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

Primary Purpose

Stroke, Cerebral Infarction, Brain Diseases

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Arm Boot Camp
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Upper extremity, Rehabilitation, Wearable device, Exercise, Randomized Controlled Trial

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Calgary
  • GF Strong Rehab Centre
  • Riverview Health Centre
  • Dalhousie University
  • Parkwood Institute
  • Toronto Rehabilitation Institute - University Health Network
  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immediate Treatment Group

Delayed Treatment Group

Arm Description

Participants will receive the intervention right away

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

Outcomes

Primary Outcome Measures

Hand counts captured using an activity monitor
Participants wear the activity monitor on stroke affected arm during waking hours for 3 consecutive days

Secondary Outcome Measures

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.
Stroke Impact Scale - hand and strength scales
Evaluate how stroke has impacted health and life
Hand count measured during the intervention sessions
Daily hand count data captured using activity monitor on the stroke affected arm during intervention period
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.
Hand counts captured using an activity monitor
Participants wear the activity monitor on stroke affected arm during waking hours for 3 consecutive days

Full Information

First Posted
December 23, 2019
Last Updated
February 1, 2023
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04232163
Brief Title
Arm Boot Camp Study: Evaluation of a Program to Increase Upper Limb Recovery After Stroke
Official Title
Evaluation of a Program to Increase Upper Limb Recovery After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebral Infarction, Brain Diseases, Central Nervous System Diseases, Cerebrovascular Disorders, Brain Ischemia, Brain Infarction, Vascular Diseases, Infarction, Nervous System Diseases, Cardiovascular Diseases
Keywords
Stroke, Upper extremity, Rehabilitation, Wearable device, Exercise, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Treatment Group
Arm Type
Experimental
Arm Description
Participants will receive the intervention right away
Arm Title
Delayed Treatment Group
Arm Type
No Intervention
Arm Description
Participants will receive usual care (no intervention), however, they will receive the intervention after a 3 week delay
Intervention Type
Behavioral
Intervention Name(s)
Arm Boot Camp
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hand counts captured using an activity monitor
Description
Participants wear the activity monitor on stroke affected arm during waking hours for 3 consecutive days
Time Frame
Post intervention (immediately following 3 weeks of intervention)
Secondary Outcome Measure Information:
Title
ArmCAM (Arm Capacity and Movement Test)
Description
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.
Time Frame
Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention)
Title
Stroke Impact Scale - hand and strength scales
Description
Evaluate how stroke has impacted health and life
Time Frame
Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention)
Title
Hand count measured during the intervention sessions
Description
Daily hand count data captured using activity monitor on the stroke affected arm during intervention period
Time Frame
Daily counts within 3 week intervention
Title
REACH Scale
Description
A self-report measure for individuals with stroke that captures how the affected arm and hand is being used outside of the clinical setting.
Time Frame
Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention)
Title
Hand counts captured using an activity monitor
Description
Participants wear the activity monitor on stroke affected arm during waking hours for 3 consecutive days
Time Frame
Follow up (two months after completion of intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice Eng, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
GF Strong Rehab Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 2G9
Country
Canada
Facility Name
Riverview Health Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3L 2P4
Country
Canada
Facility Name
Dalhousie University
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3J5
Country
Canada
Facility Name
Parkwood Institute
City
London
State/Province
Ontario
ZIP/Postal Code
B3H 3J5
Country
Canada
Facility Name
Toronto Rehabilitation Institute - University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
Evan.Foster@uhn.ca
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31662119
Citation
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.
Results Reference
background
PubMed Identifier
35135585
Citation
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. Erratum In: Trials. 2022 Mar 11;23(1):207.
Results Reference
derived

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

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