Augmented Reality-based Telerehabilitation Platform for Patients With Stroke

NCT06963645 | Withdrawn FDA Device

• 1 other identifier: 80062
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• Adherence

  Percentage of days during the 8-week intervention period that a patient completes their 30-minute rehabilitation session.

  8 weeks

• Percentage of participants who successfully complete the vFMA-UE

  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.

  Day 70

Study Arms (1)

Telerehabilitation Group

EXPERIMENTAL

Participants will use a mobile medical device in a augmented reality (AR) headset for 30 minutes daily to support their rehabilitation process after stroke by completing assessments and training programs.

Device: AR rehabilitation app

Interventions

AR rehabilitation app DEVICE

The intervention will consist of an 8-week home rehabilitation program during which the participant will have 1) a total of 7 weekly remote video visits with a therapist and 2) daily at-home exercises using the AR headset with rehabilitation app, done independently.

Also known as: Reia

Telerehabilitation Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• University of California, Berkeley: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Maarten Lansberg, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 9, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)