StrokeVHENCT05616832
How do Psychosocial Factors Relate to Completing a Home Exercise Program for Arm and Hand Recovery in Veteran Stroke Survivors?
An observational study of Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Research shows that exercising at home can improve arm and hand movement after a stroke. Unfortunately, it can be hard to exercise enough to make a difference in arm and hand movement after stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 31 Mar 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Veteran stroke survivors
Who may be able to join
- U.S. Veteran
- History of stroke
- Stroke-related hand impairment requiring concurrent standard rehabilitation therapy or for which participant indicates interest in obtaining rehabilitation therapy
- Ability to engage in therapeutic tasks, demonstrated by grasping and moving a small, everyday object such as keys or phone with affected hand
- Can put on a wrist-worn device like a watch on the paretic wrist every day, either using the nonparetic hand or with assistance from a caregiver
- Can read and understand words and numbers on a smart phone screen
Who cannot join
- No volitional movement of the affected UE
- Language barrier or cognitive impairment that precludes following 3-step commands and/or providing consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703
About this study
Official title: Examining the Association Between Psychosocial Factors and Adherence to a Home Exercise Program for Upper Extremity Recovery in Veteran Stroke Survivors
Research shows that exercising at home can improve arm and hand movement after a stroke. Unfortunately, it can be hard to exercise enough to make a difference in arm and hand movement after stroke. In this study, the investigators will try to determine things that make it easy or hard for Veterans to exercise their arm and hand after a stroke. In this study, the investigators will recruit Veteran stroke survivors who have difficulty using their arm and hand after a stroke. First, the investigators will administer surveys and questionnaires to get Veteran stroke survivors' perspectives on their self-confidence, mood, sleep, and more. Then, the investigators will ask them to track their home exercise using a wearable movement tracker (like a smart watch). Then, Veteran stroke survivors will meet with a researcher to talk about their experience doing home exercise and why they think it was easy or hard to do.
Read the detailed description
Stroke affects nearly 800,000 people in the United States annually. Around 15,000 Veterans are admitted to Veterans Affairs (VA) facilities per year with stroke, and Veterans attend approximately 60,000 outpatient visits for stroke each year. Upper extremity (UE) impairment is a common consequence of stroke that requires ongoing outpatient visits for treatment. UE impairment reduces individuals' ability to perform activities for self-care, employment, and recreation, thereby diminishing independence and quality of life.
Extensive repetitions of UE activity improve functional recovery of the UE post-stroke. However, the high amount of UE activity necessary for neuroplasticity and functional recovery is not achieved within typical therapy sessions. To circumvent limited time with a therapist, a home exercise program (HEP) is commonly prescribed. Unfortunately, patient adherence to HEP is known to be low,16-19 resulting in poor motor recovery.
Behavioral interventions are effective in improving adherence to medication regimes for people with diabetes and hypertension, as well as for physical activity among older adults. Thus, there is a growing call to provide behavioral interventions within rehabilitation to increase adherence. However, there is no evidence for efficacy of such interventions in stroke rehabilitation, let alone specifically for Veterans. Only one systematic review exists to find that 4 out of 5 randomized controlled trials failed to show statistically significant differences for a behavioral intervention over control in increasing physical activity adherence for stroke survivors among the general population. This result indicates that conventional behavioral interventions are inadequate to address adherence to HEP post-stroke. This is likely because practicing HEP after stroke is more difficult than taking medication, and promoting adherence to HEP post-stroke requires more consideration of individual survivors' psychosocial factors than is needed for medication adherence. Therefore, understanding Veteran stroke survivors' psychosocial factors is the key to developing a behavioral intervention that adequately addresses barriers to increase adherence to HEP and promote recovery.
Study design: The study will be an observational pilot study using a single group of Veteran stroke survivors.
Home exercise program: Participants will be asked to complete a home exercise program consisting of upper extremity movement to meet a daily activity goal measured by a wrist-worn tracker (like a smartwatch).
Evaluations: Outcome measures will be administered using conventional clinical assessments and questionnaires in-person prior to the home exercise program. For the clinical assessments, participants will be asked to move the affected hand and arm, grasp objects and perform prescribed tasks such as moving a small wooden block, reaching as high as possible, and opening the hand as much as possible. These clinical assessments will be videotaped for scoring. Questionnaires will not be videotaped. Completing clinical assessments and questionnaires will take about 3-5 hours and can occur over 1-2 visits, depending on the participant's preference.
Interview: Participants will be interviewed at an in-person visit after the completion of the home exercise program in a semi-structured interview format, to discuss their perspectives on barriers and facilitators to completing a home exercise program for the upper extremity. The interview will be audio-recorded for transcription. The interview will last approximately 30 minutes.
- Conditions
- Stroke
- Keywords
- stroke, rehabilitation, upper extremity, psychosocial, exercise
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Veterans with upper extremity impairment after stroke | Veterans with upper extremity impairment after stroke will be recruited for this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Home Exercise Program Adherence
Home Exercise Program adherence will be quantified as the average percent of an upper extremity activity goal met daily over 7 days after a 3-day baseline period during which activity will be tracked but no home exercise program will be completed. Accommodating for the 3-day baseline period, the 7-day home exercise program period, and any scheduling issues, the total time frame to complete this outcome will be no more than 2 weeks.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 Jul 2023
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Gabrielle Scronce, PT DPT PhD, Principal investigator, Ralph H. Johnson VA Medical Center, Charleston, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616832
- Sponsor's protocol ID
- O4277-M
- Other IDs
- 1IK1RX00427701A1
- Acronym
- VHE
- Status last verified
- Apr 2026
- First submitted
- 28 Oct 2022
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Association Between Psychosocial Factors and Adherence to a Home Exercise Program for Upper Extremity Recovery in Veteran Stroke Survivors
- ClinicalTrials.gov ID
- NCT05616832
- Acronym / sponsor ID
- VHE / O4277-M
- Conditions
- Stroke
- Keywords
- stroke, rehabilitation, upper extremity, psychosocial, exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Posted 5 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research shows that exercising at home can improve arm and hand movement after a stroke. Unfortunately, it can be hard to exercise enough to make a difference in arm and hand movement after stroke. In this study, the investigators will try to determine things that make it easy or hard for Veterans to exercise their arm and hand after a stroke. In this study, the investigators will recruit Veteran stroke survivors who have difficulty using their arm and hand after a stroke. First, the investigators will administer surveys and questionnaires to get Veteran stroke survivors' perspectives on their self-confidence, mood, sleep, and more. Then, the investigators will ask them to track their home exercise using a wearable movement tracker (like a smart watch). Then, Veteran stroke survivors will meet with a researcher to talk about their experience doing home exercise and why they think it was easy or hard to do.
Detailed description
Stroke affects nearly 800,000 people in the United States annually. Around 15,000 Veterans are admitted to Veterans Affairs (VA) facilities per year with stroke, and Veterans attend approximately 60,000 outpatient visits for stroke each year. Upper extremity (UE) impairment is a common consequence of stroke that requires ongoing outpatient visits for treatment. UE impairment reduces individuals' ability to perform activities for self-care, employment, and recreation, thereby diminishing independence and quality of life.
Extensive repetitions of UE activity improve functional recovery of the UE post-stroke. However, the high amount of UE activity necessary for neuroplasticity and functional recovery is not achieved within typical therapy sessions. To circumvent limited time with a therapist, a home exercise program (HEP) is commonly prescribed. Unfortunately, patient adherence to HEP is known to be low,16-19 resulting in poor motor recovery.
Behavioral interventions are effective in improving adherence to medication regimes for people with diabetes and hypertension, as well as for physical activity among older adults. Thus, there is a growing call to provide behavioral interventions within rehabilitation to increase adherence. However, there is no evidence for efficacy of such interventions in stroke rehabilitation, let alone specifically for Veterans. Only one systematic review exists to find that 4 out of 5 randomized controlled trials failed to show statistically significant differences for a behavioral intervention over control in increasing physical activity adherence for stroke survivors among the general population. This result indicates that conventional behavioral interventions are inadequate to address adherence to HEP post-stroke. This is likely because practicing HEP after stroke is more difficult than taking medication, and promoting adherence to HEP post-stroke requires more consideration of individual survivors' psychosocial factors than is needed for medication adherence. Therefore, understanding Veteran stroke survivors' psychosocial factors is the key to developing a behavioral intervention that adequately addresses barriers to increase adherence to HEP and promote recovery.
Study design: The study will be an observational pilot study using a single group of Veteran stroke survivors.
Home exercise program: Participants will be asked to complete a home exercise program consisting of upper extremity movement to meet a daily activity goal measured by a wrist-worn tracker (like a smartwatch).
Evaluations: Outcome measures will be administered using conventional clinical assessments and questionnaires in-person prior to the home exercise program. For the clinical assessments, participants will be asked to move the affected hand and arm, grasp objects and perform prescribed tasks such as moving a small wooden block, reaching as high as possible, and opening the hand as much as possible. These clinical assessments will be videotaped for scoring. Questionnaires will not be videotaped. Completing clinical assessments and questionnaires will take about 3-5 hours and can occur over 1-2 visits, depending on the participant's preference.
Interview: Participants will be interviewed at an in-person visit after the completion of the home exercise program in a semi-structured interview format, to discuss their perspectives on barriers and facilitators to completing a home exercise program for the upper extremity. The interview will be audio-recorded for transcription. The interview will last approximately 30 minutes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Veterans with upper extremity impairment after stroke | – | –Veterans with upper extremity impairment after stroke will be recruited for this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veteran stroke survivors
Key inclusion criteria (6 listed)
- U.S. Veteran
- History of stroke
- Stroke-related hand impairment requiring concurrent standard rehabilitation therapy or for which participant indicates interest in obtaining rehabilitation therapy
- Ability to engage in therapeutic tasks, demonstrated by grasping and moving a small, everyday object such as keys or phone with affected hand
- Can put on a wrist-worn device like a watch on the paretic wrist every day, either using the nonparetic hand or with assistance from a caregiver
Key exclusion criteria (2 listed)
- No volitional movement of the affected UE
- Language barrier or cognitive impairment that precludes following 3-step commands and/or providing consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Home Exercise Program Adherence
Time frame: 7 days
Home Exercise Program adherence will be quantified as the average percent of an upper extremity activity goal met daily over 7 days after a 3-day baseline period during which activity will be tracked but no home exercise program will be completed. Accommodating for the 3-day baseline period, the 7-day home exercise program period, and any scheduling issues, the total time frame to complete this outcome will be no more than 2 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Gabrielle Scronce, PT DPT PhD principal investigator
Ralph H. Johnson VA Medical Center, Charleston, SC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by VA Office of Research and Development 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 6 inclusion and 2 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 5 May 2026. 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?
Yes. Results are posted in the registry (first posted 5 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Home Exercise Program Adherence (time frame: 7 days). 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 5 May 2026.