- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05616832
How do Psychosocial Factors Relate to Completing a Home Exercise Program for Arm and Hand Recovery in Veteran Stroke Survivors? (VHE)
Examining the Association Between Psychosocial Factors and Adherence to a Home Exercise Program for Upper Extremity Recovery in Veteran Stroke Survivors
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29401-5703
- Ralph H. Johnson VA Medical Center, Charleston, SC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- No volitional movement of the affected UE
- Language barrier or cognitive impairment that precludes following 3-step commands and/or providing consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
Veterans with upper extremity impairment after stroke
Veterans with upper extremity impairment after stroke will be recruited for this study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
7 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gabrielle Scronce, PT DPT PhD, Ralph H. Johnson VA Medical Center, Charleston, SC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- O4277-M
- 1IK1RX00427701A1 (Registry Identifier: Department of Veterans Affairs)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University of PittsburghRecruitingHemorrhagic Stroke | Embolic Stroke of Undetermined Source | Ischemic Stroke, Cryptogenic | Recurrent Ischemic Stroke | Ischemic Stroke, EmbolicUnited States
-
National Assembly ClinicBayero University Kano, NigeriaRecruitingStroke | Stroke Hemorrhagic | Stroke Ischemic | Hemiparesis After StrokeNigeria
-
Mahidol UniversityNot yet recruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke SurvivorsThailand
-
Mahidol UniversityRecruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke PatientThailand
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
University Hospital HeidelbergCompletedAcute Ischemic Stroke | Acute Ischemic Stroke AIS | Acute Ischemic Stroke PatientsGermany
-
Samsung Medical CenterCompletedChronic Stroke | Subacute Stroke | ExoskeletonSouth Korea