Stroke
Conditions
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).
Interventions
DEVICEAR 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.
Sponsors
Stanford University
University of California, Berkeley
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMaarten Lansberg, MD, PhD
Stanford University
Outcome results
None listed