Just In Time Intervention to Enhance Physical Activity Among Stroke Survivors

NCT ID: NCT06693999

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-06-30
• Study Completion Date: 2026-12-31

Brief Summary

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

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Adult stroke Survivors

This arm consists of stroke survivors with specified inclusion/exclusion criteria who will receive goal reminders and motivational, in addition to coping messages through Google Pixel Watches.

Group Type: OTHER

Google-Pixel Watch 3

Intervention Type: DEVICE

The participant will wear Google-Pixel Watch 3 for at least 10 hours during the 3-month intervention and will receive goal reminders and motivational and coping messages through those watches. At baseline and after 3-months intervention, demographics (standard questionnaire pertaining to subjects' age, sex, race, education and income), technology literacy (eHealth Literacy Scale pertaining to subjects' ability to perform a number of tasks such as turning on the device, using internet and communication), and wearables affinity (pertains to how the subject currently uses wearable in their daily living tasks) will be measured.

Exercise prompts

Intervention Type: BEHAVIORAL

The participants will receive goal reminders.

Interventions

Google-Pixel Watch 3

The participant will wear Google-Pixel Watch 3 for at least 10 hours during the 3-month intervention and will receive goal reminders and motivational and coping messages through those watches. At baseline and after 3-months intervention, demographics (standard questionnaire pertaining to subjects' age, sex, race, education and income), technology literacy (eHealth Literacy Scale pertaining to subjects' ability to perform a number of tasks such as turning on the device, using internet and communication), and wearables affinity (pertains to how the subject currently uses wearable in their daily living tasks) will be measured.

Intervention Type: DEVICE

Exercise prompts

The participants will receive goal reminders.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ramin Zand

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ramin Zand, MD

Role: CONTACT

rzand@pennstatehealth.psu.edu

717-531-0003 ext. 320854

Other Identifiers

STUDY00025868

Identifier Type: -

Identifier Source: org_study_id