NCT04232163

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable stroke

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

August 15, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

2.4 years

First QC Date

December 23, 2019

Last Update Submit

February 1, 2023

Conditions

StrokeCerebral InfarctionBrain DiseasesCentral Nervous System DiseasesCerebrovascular DisordersBrain IschemiaBrain InfarctionVascular DiseasesInfarctionNervous System DiseasesCardiovascular Diseases

Keywords

StrokeUpper extremityRehabilitationWearable deviceExerciseRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • ArmCAM (Arm Capacity and Movement Test)

    Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention)

  • Stroke Impact Scale - hand and strength scales

    Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention)

  • Hand count measured during the intervention sessions

    Daily counts within 3 week intervention

  • REACH Scale

    Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention)

  • Hand counts captured using an activity monitor

    Follow up (two months after completion of intervention)

Study Arms (2)

Immediate Treatment Group

EXPERIMENTAL

Participants will receive the intervention right away

Behavioral: Arm Boot Camp

Delayed Treatment Group

NO INTERVENTION

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

Interventions

Arm Boot CampBEHAVIORAL

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.

Immediate Treatment Group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

GF Strong Rehab Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Location

Riverview Health Centre

Winnipeg, Manitoba, R3L 2P4, Canada

Location

Dalhousie University

Halifax, Nova Scotia, B3H 3J5, Canada

Location

Parkwood Institute

London, Ontario, B3H 3J5, Canada

Location

Toronto Rehabilitation Institute - University Health Network

Toronto, Ontario, Evan.Foster@uhn.ca, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (3)

  • 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.

    PMID: 31662119BACKGROUND

  • 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.

    PMID: 39727287DERIVED

  • 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.

    PMID: 35135585DERIVED

MeSH Terms

Conditions

StrokeCerebral InfarctionBrain DiseasesCentral Nervous System DiseasesCerebrovascular DisordersBrain IschemiaBrain InfarctionVascular DiseasesInfarctionNervous System DiseasesCardiovascular DiseasesMotor Activity

Condition Hierarchy (Ancestors)

IschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisBehavior

Study Officials

  • Janice Eng, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 23, 2019

First Posted

January 18, 2020

Study Start

August 15, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 3, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(7)