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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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 groups in NCT05616832
Study groupRoleWhat they receive
Veterans with upper extremity impairment after strokeVeterans 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.

  1. 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.

  1. First posted15 Nov 2022
  2. Study start1 Jul 2023
  3. Primary completion31 Mar 2025
  4. Study completion31 Mar 2025

Resources

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)
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
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

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