Education + Coaching for Stroke

(U4S Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas, El Paso

Disqualifiers: Unable to consent, No transportation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

46 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Camila Torriani-Pasin, PhD, PT

Principal Investigator

The University of Texas at El Paso

Eligibility Criteria

The United4Stroke program is for individuals aged 18 or older who have experienced a stroke at least six months ago. Family caregivers are also welcome to participate. The program takes place in El Paso, TX and includes group education on physical activity and individual coaching sessions.

Inclusion Criteria

I had a stroke more than 6 months ago.

I can travel to the UTEP physical therapy building for visits.

My health condition is stable and not worsening quickly.

Exclusion Criteria

Individuals who attend less than 60% of the group-based educational sessions

I don't have a way to get to the study visits.

I need a caregiver who cannot attend with me.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Initial Assessment

Participants undergo initial assessments including cognitive and physical evaluations, and are fitted with movement sensors

1 week

1 visit (in-person)

Intervention

Participants attend group-based education sessions and receive individualized coaching to increase physical activity and reduce sedentary behavior

12 weeks

12 visits (in-person)

Post-Intervention Assessment

Participants undergo post-intervention assessments to evaluate progress and provide feedback

1 week

2 visits (in-person)

Follow-up

Participants are monitored for retention of physical activity improvements and quality of life one month after the program concludes

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• United4Stroke (U4S)

Trial Overview This study tests a combination of group-based education and personalized coaching aimed at increasing physical activity and reducing sedentary time among stroke survivors. Participants will attend sessions over several months, including evaluations before, during, and after the program.

Participant Groups

Group I: Group-Based Education plus Individualized Coaching Experimental Treatment 2 Interventions

Participants 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.

Group II: Group-Based Education Only Active Control 1 Intervention

Participants 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.

Who Is Running the Clinical Trial?

University of Texas, El Paso

Lead Sponsor

Trials

17

Recruited

3,000+