Augmented Reality-based Telerehabilitation Platform for Patients With Stroke

NCT ID: NCT06963645

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Telerehabilitation Group

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.

Group Type EXPERIMENTAL

AR rehabilitation app

Intervention Type 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.

Interventions

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AR rehabilitation app

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.

Intervention Type DEVICE

Other Intervention Names

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Reia

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Berkeley

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Maarten Lansberg

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maarten Lansberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Central Contacts

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Study Team

Role: CONTACT

650-723-8886

Other Identifiers

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80062

Identifier Type: -

Identifier Source: org_study_id

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