StrokeNCT05964400
duoABLE for People With Stroke and Their Caregivers
A study testing duoABLE in people with Stroke and Stroke Ischemic, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke Ischemic, Stroke Hemorrhagic
- What is being tested?
- duoABLE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 24 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- Reside in an institutional setting
- Are currently incarcerated
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Kinesiology, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: duoABLE for People With Stroke and Their Caregivers (Feasibility)
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.
- Conditions
- Stroke, Stroke Ischemic, Stroke Hemorrhagic, Stroke Sequelae
- Being tested
- duoABLE
- Keywords
- lifestyle, physical activity, duoABLE, ABLE, rehabilitation, rehab, occupational therapy, physical therapy, stroke
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duoABLEBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| duoABLE | Experimental | 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 Receives: Behavioral: duoABLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant satisfaction
Measured using the Client Satisfaction Questionnaire-8 (CSQ-8)
Measured: Score at week 8
Secondary outcomes (5)
Change in activity restrictions
Proportion of activities retained assessed at baseline and 8-weeks by the Activity Card Sort 3
Measured: Baseline to 8 weeks
Change in sedentary minutes per day
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.
Measured: Baseline to 8 weeks
Change in daily step count
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.
Measured: Baseline to 8 weeks
Change in Health-related quality of life
Change in score on the EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) measured at baseline and week 8
Measured: Baseline to 8 weeks
Adverse event count
Total count of adverse events over the course of the study based on an adverse events questionnaire completed at 8 weeks
Measured: Count of adverse events at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Sep 2023
- Primary completion24 Aug 2024
- Study completion24 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Responsible party
- Sponsor
- Investigators
- Emily A Kringle, PhD, OTR/L, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964400
- Sponsor's protocol ID
- duoABLE
- Other IDs
- AOTFIRG23KRINGLE
- Status last verified
- Oct 2024
- First submitted
- 18 Jul 2023
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There are no current plans to share data with other investigators. Upon the completion of the study, a de-identified dataset that includes questionnaire data, raw and processed activPAL data, and transcribed interview data will be created and stored in the DWELL Laboratory at the University of Minnesota. The PI will consider individual requests for data sharing and provide only the necessary de-identified data upon reasonable request, under a University of Minnesota data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- duoABLE for People With Stroke and Their Caregivers (Feasibility)
- ClinicalTrials.gov ID
- NCT05964400
- Acronym / sponsor ID
- duoABLE
- Conditions
- Stroke, Stroke Ischemic, Stroke Hemorrhagic, Stroke Sequelae
- Keywords
- lifestyle, physical activity, duoABLE, ABLE, rehabilitation, rehab, occupational therapy, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 24 Aug 2024 (actual)
- Study completion
- 24 Aug 2024 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| duoABLE | Experimental | Behavioral: duoABLEStroke 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| duoABLEStroke 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 | Behavioural | duoABLE |
Primary outcome
Participant satisfaction
Time frame: Score at week 8
Measured using the Client Satisfaction Questionnaire-8 (CSQ-8)
5 secondary outcomes
Change in activity restrictions
Time frame: Baseline to 8 weeks
Change in sedentary minutes per day
Time frame: Baseline to 8 weeks
Change in daily step count
Time frame: Baseline to 8 weeks
Change in Health-related quality of life
Time frame: Baseline to 8 weeks
Adverse event count
Time frame: Count of adverse events at week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: Yes. There are no current plans to share data with other investigators. Upon the completion of the study, a de-identified dataset that includes questionnaire data, raw and processed activPAL data, and transcribed interview data will be created and stored in the DWELL Laboratory at the University of Minnesota. The PI will consider individual requests for data sharing and provide only the necessary de-identified data upon reasonable request, under a University of Minnesota data use agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily A Kringle, PhD, OTR/L principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing duoABLE in people with Stroke and Stroke Ischemic, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant satisfaction (time frame: Score at week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.