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

Stroke Clinical Trial

Official title:

Evaluation of a Program to Increase Upper Limb Recovery After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04232163
• Other study ID #: H19-02005
• Status: Completed
• Phase: N/A
• Start date: August 15, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Infarction
• Brain Ischemia
• Cardiovascular Diseases
• Central Nervous System Diseases
• Cerebral Infarction
• Cerebrovascular Disorders
• Infarction
• Nervous System Diseases
• Stroke
• Vascular Diseases

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Dalhousie University	Halifax	Nova Scotia
Canada	Parkwood Institute	London	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto Rehabilitation Institute - University Health Network	Toronto	Ontario
Canada	GF Strong Rehab Centre	Vancouver	British Columbia
Canada	Riverview Health Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention)
Secondary	Stroke Impact Scale - hand and strength scales	Evaluate how stroke has impacted health and life	Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention)
Secondary	Hand count measured during the intervention sessions	Daily hand count data captured using activity monitor on the stroke affected arm during intervention period	Daily counts within 3 week intervention
Secondary	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.	Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention)
Secondary	Hand counts captured using an activity monitor	Participants wear the activity monitor on stroke affected arm during waking hours for 3 consecutive days	Follow up (two months after completion of intervention)