Stroke, Stroke Hemorrhagic, Stroke Ischemic, Stroke Sequelae
Conditions
Keywords
lifestyle, physical activity, duoABLE, ABLE, rehabilitation, rehab, occupational therapy, physical therapy, stroke
Brief summary
The goal of this intervention study is to test whether a behavioral program that involves people with stroke and their caregivers is acceptable, safe, and can promote physically active lifestyles using enjoyable activities. Participant duos (person with stroke and their caregiver) will be asked to complete assessments at 2 timepoints, wear an activity tracker, participate in 12 sessions with an occupational therapist, and complete an interview.
Interventions
BEHAVIORALduoABLE
Stroke participant-caregiver duos (dyads) will meet with an occupational therapist 12 times (2x/week for 6 weeks, approximately 30 minutes/session) to apply activity monitoring, activity scheduling, collaborative problem solving, self-assessment, and social interdependence to self-selected activities that aim to increase both dyad members' physical activity levels
Sponsors
American Occupational Therapy Foundation
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(Stroke Participants): * Stroke diagnosed more than 6 months ago * Are 18 years of age or older * Report ≥6 hours of sedentary behavior on a typical day OR report engagement in ≤90 minutes of moderate-to-vigorous physical activity in the past week * Reside in a community-based setting * Are mobile within their home, with or without an assistive device and without physical assistance * Are able to identify an eligible caregiver who will engage in assessments and intervention. Inclusion Criteria (Caregiver Participants): * Are 18 years of age or older * Report ≥6 hours of sedentary behavior on a typical day OR report engagement in ≤90 minutes of moderate-to-vigorous physical activity in the past week * Reside in a community-based setting * Are mobile within their home, with or without an assistive device and without physical assistance
Exclusion criteria
(Stroke Participants): * Severe aphasia * Are currently receiving chemotherapy or radiation treatments for cancer * Have a medical diagnosis of neurodegenerative disorder (i.e., dementia, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma) * Received inpatient treatment for substance use disorder or psychiatric condition within the past 12 months * Have a history of skin sensitivity related to adhesives * Are pregnant or expecting to become pregnant in the next 2 months * Reside in an institutional setting * Are currently incarcerated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant satisfaction | Score at week 8 | Measured using the Client Satisfaction Questionnaire-8 (CSQ-8) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in daily step count | Baseline to 8 weeks | Count of steps per day, measured using the activPAL micro4 (mean daily step count determined by 7-day wear protocol) at baseline and week 8. |
| Change in sedentary minutes per day | Baseline to 8 weeks | Minutes of sedentary time per day, measured using the activPAL micro4 (mean minutes per day determined by 7-day wear protocol) at baseline and week 8. |
| Change in activity restrictions | Baseline to 8 weeks | Proportion of activities retained assessed at baseline and 8-weeks by the Activity Card Sort 3 |
| Change in Health-related quality of life | Baseline to 8 weeks | Change in score on the EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) measured at baseline and week 8 |
| Adverse event count | Count of adverse events at week 8 | Total count of adverse events over the course of the study based on an adverse events questionnaire completed at 8 weeks |
Countries
United States
Outcome results
None listed