Just In Time Intervention to Enhance Physical Activity Among Stroke Survivors

NCT06693999 | Not Yet Recruiting

• 1 other identifier: STUDY00025868
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Keywords

Stroke; Physical Activity; Wearable tracker; Smart Phone

Outcome Measures

Primary Outcomes (1)

• Number of participants retained

  The number of participants who remain in the study until its conclusion.

  3 months

Secondary Outcomes (3)

• Number of subjects recruited for the study

  3 months

• Number of hours devices were worn

  3 months

• Number of prompts

  3 months

Other Outcomes (2)

• Weekly Goal Adherence

  3 months

• Minutes of Physical Activity

  3 months

Study Arms (1)

Adult stroke Survivors

OTHER

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.

Device: Google-Pixel Watch 3; Behavioral: Exercise prompts

Interventions

Google-Pixel Watch 3 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.

Adult stroke Survivors

Exercise prompts BEHAVIORAL

The participants will receive goal reminders.

Adult stroke Survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Community-Dwelling: Participants should be living independently in the community rather than in institutional settings such as nursing homes or hospitals.
• Independently Mobile: Participants must be able to walk without any aid or assistance, corresponding to a modified Rankin Scale (mRS) score of 0-2.
• Physically Inactive: Participants should have engaged in less than 10 minutes of moderate-to-vigorous physical activity (MVPA) in the past week.
• Internet Access: Participants must have access to the Internet for at least a few hours every day.
• Medically Cleared to participate: Before enrollment, participants must obtain medical clearance to ensure they are fit to participate in the study.

You may not qualify if:

• Participating in Another Research Project Involving Physical Activity: To avoid potential confounding variables that could affect the study's outcomes.
• 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.
• 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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Central Study Contacts

Ramin Zand, MD

CONTACT

717-531-0003; rzand@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11