United4Stroke (U4S) - El Paso Network Stroke Community Program
Part of paid clinical trials in El Paso, Texas.
- Sponsor
- University of Texas, El Paso
- Study ID
- NCT06970210
- Status
- Enrolling By Invitation
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Group-Based Education — BEHAVIORALThe group-based education will consist of group sessions led by research staff, covering topics such as physical activity, sedentary behavior, balance and fall prevention, and activities of daily living. Social interactions amongst group members will be facilitated through group activities and discussions regarding the topics being discussed.
- Individualized Coaching — BEHAVIORALIndividualized coaching aims to increase the participants daily step count. Participants will be encouraged to achieve step count increases of 2%, 5%, or 10% per week or visit, depending on their readiness and willingness to progress. SMART goal-setting strategies will be employed to assist with the goal setting. Participants may also receive coaching related to reducing sedentary behavior and engaging in physical activities.
Study Details
What is United4Stroke (U4S)? United4Stroke is a research program at the University of Texas at El Paso (UTEP) that aims to help stroke survivors become more active and reduce sedentary time through education, movement, and personalized coaching. Where Does It Happen? All sessions take place at: UTEP's Rehabilitation Sciences Complex located at 3333 North Mesa Street, El Paso, TX 79902 What is Involved? The program includes 12 total visits over several months: * 8 group sessions (held every two weeks) * 4 individual evaluation visits (before, during, and after the program) Who Can Participate? * Individuals 18 years of age or older who have had a stroke at least 6 months prior to joining the study. * Family caregivers may also join What Happens During the Visits? First Visit: * Learn about the study and give consent * Answer questions about memory, movement, general health, and daily activity * Do walking and mobility tests * Get fitted with a small movement sensor (ActivPAL) and a Fitbit Group Sessions (Visits 2-8): * Topics: physical activity, sitting less, balance and falls, and activities of daily living * Led by UTEP physical therapy faculty * Includes group discussions and hands-on activities * Some participants will also get one-on-one coaching to help with physical activity engagement, daily step count, and reducing sedentary behavior. Follow-Up Visits (Visits 9 and 11): * Repeat earlier tests to check progress * Share feedback about the program Final Visit (Visit 10): * Celebrate progress! * Social gathering, certificates, and a presentation of results Goal: To support stroke survivors in becoming more active and living healthier, more independent lives-step by step.
Key Dates
- Start date
- Jun 2, 2025
- Status verified
- Apr 2025
- Primary completion
- Dec 20, 2028
- Completion
- Dec 20, 2028
Study Design
- Enrollment
- 46 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Group-Based Education OnlyParticipants assigned to the group-based education arm will attend the U4S program which will consist of group-based educational sessions led by research staff, covering topics such as physical activity, sedentary behavior, balance and fall prevention, and activities of daily living. This group will not receive individualized coaching aimed at increasing daily step count, but will receive a Fitbit to be worn during the program.
- Experimental: Group-Based Education plus Individualized CoachingParticipants assigned to the group-based education arm will attend the U4S program which will consist of group-based educational sessions led by research staff, covering topics such as physical activity, sedentary behavior, balance and fall prevention, and activities of daily living. This group will receive individualized coaching aimed at increasing daily step count, reducing sedentary behavior, and engaging in physical activities. They will also receive a Fitbit to be worn during the program.
Primary Outcome Measure
Daily Step Count [ Time Frame: Baseline, week 6 (during intervention), week 13 (post-intervention), and week 19 (follow-up). ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Texas at El Paso: Rehabilitation Sciences Complex | El Paso | Texas | 79902 | - |
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