Clinical trial NCT05964400: duoABLE for People With Stroke and Their Caregivers
Official title: duoABLE for People With Stroke and Their Caregivers (Feasibility)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Stroke Ischemic
Stroke Hemorrhagic
Stroke Sequelae
Keywords: lifestyle
physical activity
duoABLE
ABLE
rehabilitation
rehab
occupational therapy
physical therapy
stroke
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: American Occupational Therapy Foundation
First posted: 2023-07-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Exclusion Criteria (Caregiver Participants):

* Have a history of skin sensitivity related to adhesives
* 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
* Are pregnant or expecting to become pregnant in the next 2 months
* Reside in an institutional setting
* Are currently incarcerated

Primary outcomes:
measure: Participant satisfaction
timeFrame: Score at week 8
Secondary outcomes:
measure: Change in activity restrictions
timeFrame: Baseline to 8 weeks
measure: Change in sedentary minutes per day
timeFrame: Baseline to 8 weeks
measure: Change in daily step count
timeFrame: Baseline to 8 weeks
measure: Change in Health-related quality of life
timeFrame: Baseline to 8 weeks
measure: Adverse event count
timeFrame: Count of adverse events at week 8
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: School of Kinesiology, University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Emily A Kringle, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: