Augmented Reality-based Telerehabilitation Platform for Patients With Stroke

Not Applicable

Not yet recruiting

• Conditions: Stroke

• Registration Number: NCT06963645
• Lead Sponsor: Stanford University

Brief Summary

The study is to 1) determine the feasibility of the use of our augmented reality (AR) rehabilitation program, including its preliminary efficacy, 2) determine the feasibility of obtaining an augmented reality assessment based on the Fugl-Meyer Assessment - Upper Extremity (FMA-UE).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-30
• Study First Submitted QC: 2025-04-30
• Last Update Submitted: 2025-04-30
• Study First Posted: 2025-05-09
• Last Update Posted: 2025-05-09
• Study Start: 2025-06
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. 18 years or older
2. ≥3 months post ischemic or hemorrhagic stroke
3. Upper extremity deficit with an FMA-UE score between 20-50
4. Able to operate the AR device independently or with the help of a caregiver
5. Sufficiently proficient in the English language to follow instructions from Reia

Exclusion Criteria

1. History of developmental, neurological or psychological impairment leading to functional disability
2. Vision or visual field impairment that interferes with the use of the AR headset
3. Severe photosensitivity that makes use of the AR headset uncomfortable
4. History of visually provoked seizures
5. Hearing aids
6. Cardiac pacemaker
7. Implantable cardioverter-defibrillator (ICD)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adherence	8 weeks	Percentage of days during the 8-week intervention period that a patient completes their 30-minute rehabilitation session.
Percentage of participants who successfully complete the vFMA-UE	Day 70	Feasibility of obtaining the Fugl-Meyer Assessment - Upper Extremity (vFMA-UE) unsupervised, described by the percentage of participants who successfully complete the vFMA-UE at home on day 70, among patients who attempted to do the unsupervised vFMA-UE.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States