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Completed

NCT Number: NCT04232163

Arm Boot Camp Study: 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.

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Key information

Conditions

Stroke Behavior Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Infarction Cerebrovascular Disorders Infarction Ischemia Motor Activity Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arm Boot Camp

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.

Primary outcomes

  1. Hand counts captured using an activity monitor

    Time frame: 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 outcomes

  1. ArmCAM (Arm Capacity and Movement Test)

    Time frame: 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.

  2. Stroke Impact Scale - hand and strength scales

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

    Evaluate how stroke has impacted health and life

  3. Hand count measured during the intervention sessions

    Time frame: Daily counts within 3 week intervention

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

  4. REACH Scale

    Time frame: 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.

  5. Hand counts captured using an activity monitor

    Time frame: Follow up (two months after completion of intervention)

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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Evaluation of a Program to Increase Upper Limb Recovery After Stroke

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2020
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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