AzTrials
AzTrials

StrokeNCT04232163

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

A study testing Arm Boot Camp in people with Stroke and Cerebral Infarction, run by University of British Columbia at 7 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Stroke, Cerebral Infarction, Brain Diseases
What is being tested?
Arm Boot Camp
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
7 sitesCanada
Study dates
15 Aug 2020to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Canada7 sites

  • University of Calgary

    Calgary, Alberta, T2N 2T9

  • Dalhousie University

    Halifax, Nova Scotia, B3H 3J5

  • Parkwood Institute

    London, Ontario, B3H 3J5

  • Toronto Rehabilitation Institute - University Health Network

    Toronto, Ontario, Evan.Foster@uhn.ca

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • GF Strong Rehab Centre

    Vancouver, British Columbia, V5Z 2G9

  • Riverview Health Centre

    Winnipeg, Manitoba, R3L 2P4

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Arm Boot Camp
Keywords
Stroke, Upper extremity, Rehabilitation, Wearable device, Exercise, Randomized Controlled Trial
Medical subject headings
Stroke, Cerebral Infarction, Brain Diseases, Central Nervous System Diseases, Cerebrovascular Disorders, Brain Ischemia, Brain Infarction, Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arm Boot CampBehavioural

    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.

Study groups in NCT04232163
Study groupRoleWhat they receive
Immediate Treatment GroupExperimentalParticipants will receive the intervention right away
Receives: Behavioral: Arm Boot Camp
Delayed Treatment GroupNo interventionParticipants will receive usual care (no intervention), however, they will receive the intervention after a 3 week delay

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hand counts captured using an activity monitor

    Participants wear the activity monitor on stroke affected arm during waking hours for 3 consecutive days

    Measured: Post intervention (immediately following 3 weeks of intervention)

Secondary outcomes (5)

  1. 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.

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

  2. Stroke Impact Scale - hand and strength scales

    Evaluate how stroke has impacted health and life

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

  3. Hand count measured during the intervention sessions

    Daily hand count data captured using activity monitor on the stroke affected arm during intervention period

    Measured: Daily counts within 3 week intervention

  4. 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.

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

  5. Hand counts captured using an activity monitor

    Participants wear the activity monitor on stroke affected arm during waking hours for 3 consecutive days

    Measured: Follow up (two months after completion of intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2020
  2. Study start15 Aug 2020
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04232163
Sponsor's protocol ID
H19-02005
Status last verified
Feb 2023
First submitted
23 Dec 2019
Last updated
3 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31662119

  • 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.

    PubMed 39727287

  • 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.

    PubMed 35135585

Questions about this trial

What is this clinical trial studying?

A study testing Arm Boot Camp in people with Stroke and Cerebral Infarction, run by University of British Columbia at 7 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hand counts captured using an activity monitor (time frame: Post intervention (immediately following 3 weeks of intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04232163, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in