Clinical trial NCT04232163: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 62
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hand counts captured using an activity monitor
timeFrame: Post intervention (immediately following 3 weeks of intervention)
Secondary outcomes:
measure: ArmCAM (Arm Capacity and Movement Test)
timeFrame: Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention)
measure: Stroke Impact Scale - hand and strength scales
timeFrame: Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention)
measure: Hand count measured during the intervention sessions
timeFrame: Daily counts within 3 week intervention
measure: REACH Scale
timeFrame: Post intervention (immediately following 3 weeks of intervention), follow up (2 months after completion of intervention)
measure: Hand counts captured using an activity monitor
timeFrame: Follow up (two months after completion of intervention)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: GF Strong Rehab Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: Riverview Health Centre
state: Manitoba
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
city: London
country: Canada
facility: Parkwood Institute
state: Ontario
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute - University Health Network
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: University of British Columbia
name: Janice Eng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.