Technology-supported Motor Rehabilitation for People With Rett Syndrome

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Georgetown University
Study ID
NCT07418905
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
4 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • computer gaming — BEHAVIORAL
    Investigators will personalize gaming sessions based on the motivators and interests of each participant. During each intervention session, the participant will be encouraged to initiate voluntary hand separations in order to activate or control the gaming activity.

Study Details

This study focuses on improving purposeful arm use while simultaneously reducing engagement in stereotypies. It is typically expected that the training period for this study will last about 6 months. The first half of the training periods will be devoted to learning to separate hands to stop the stereotypies that interfere with arm and hand use. In this first half, participants will also need to learn to keep arms apart in order to be actively involved in the chosen game. The second half of the training period will be devoted to learning to stop stereotypies and reach for targets that are intended to start game play. When not touching the targets, the software will interpret that the game should stop and wait for the next target to be touched.

Key Dates

Start date
Oct 1, 2024
Status verified
Feb 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
14 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gaming system
    The study will involve several sequential phases: pre-intervention testing, cause-and-effect training/intervention, and a post-intervention testing phase. The aim is to learn to control stereotypies and learn to interact with their environment to increase independent play skills. Training will take place using telemedicine methods. The game consists of computer generated games developed by the researchers specifically for the needs of individuals with dyspraxia. The images or video that the participant will watch will be projected to the table. The participant's hand movements to stop their stereotypies will be detected as the Start signal for the game to begin. When hands return to their stereotypy, the computer camera will detect that as the Stop signal and the game will pause until hands are detected separated from each other again.

Primary Outcome Measure

Counts and timing of obligatory stereotypies [ Time Frame: 60 min functional assessment periods: one just before start of intervention (baseline) and one at the end of intervention (post-intervention testing) Weekly data collection from intervention sessions: enrollment to end of intervention 26 weeks later. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Georgetown University School of MedicineBethesdaMaryland20814-

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