Just in Time Intervention to Enhance Physical Activity Among Stroke Survivors

Not Applicable

Not yet recruiting

• Conditions: Stroke

• Registration Number: NCT06693999
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

A 3-month single-arm pilot trial to evaluate the feasibility of an automated and individualized coping intervention among stroke survivors.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-15
• Study First Submitted QC: 2024-11-15
• Study First Posted: 2024-11-19
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Study Start: 2025-10
• Primary Completion: 2026-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Adult Patients Diagnosed with Stroke: Participants must be adults (age ≥ 18) who have been clinically diagnosed with a stroke between 3 months and 3 years.
2. Community-Dwelling: Participants should be living independently in the community rather than in institutional settings such as nursing homes or hospitals.
3. Independently Mobile: Participants must be able to walk without any aid or assistance, corresponding to a modified Rankin Scale (mRS) score of 0-2.
4. Physically Inactive: Participants should have engaged in less than 10 minutes of moderate-to-vigorous physical activity (MVPA) in the past week.
5. Internet Access: Participants must have access to the Internet for at least a few hours every day.
6. Medically Cleared to participate: Before enrollment, participants must obtain medical clearance to ensure they are fit to participate in the study.

Exclusion Criteria

1. Participating in Another Research Project Involving Physical Activity: To avoid potential confounding variables that could affect the study's outcomes.
2. Planning to Move or Have Surgery in the Next 6 Months: Participants who plan to move or undergo surgery within the next six months may face disruptions that could affect their ability to complete the study.
3. Cognitive Impairment: Cognitive impairment can affect a participant's ability to understand and follow study protocols, which is crucial for informed consent and reliable data collection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of participants retained	3 months	The number of participants who remain in the study until its conclusion.

Secondary Outcome Measures

Name	Time	Method
Number of subjects recruited for the study	3 months	This measures how effectively participants are being enrolled in the study.
Number of hours devices were worn	3 months	Number of hours device were worn by the subjects.
Number of prompts	3 months	This refers to the number of prompts responded by participants throughout the study duration.