Technology-supported Motor Rehabilitation for People With Rett Syndrome

NCT07418905 | Active Not Recruiting

• 1 other identifier: 13GW0488B
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rett Syndrome

Keywords

habilitation; recovery of function; purposeful arm use; gaming

Outcome Measures

Primary Outcomes (3)

• Counts and timing of obligatory stereotypies

  We will collect two variables: the number of times the participant engages in her unique stereotypy and the length of time (in seconds) that the stereotypy occurs. Data will be collected from both weekly intervention sessions and the two functional assessments. Functional data will be collected from the movements made by the individual as well as from BEFORE and AFTER questionnaires to be completed by the caregivers of the participant.

  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.

• Timing and number of separations (ceasing stereotypies)

  Data will be collected from intervention sessions and the two functional assessments. Data will be in both the number of times each girls separates hands (counts) and timing (in seconds) to record how long hands remained apart. Functional data will be collected from the movements made by the individual as well as from BEFORE and AFTER questionnaires to be completed by the caregivers of the participant.

  Two 60 minute assessment periods: one just before start of intervention (baseline) and one at the end of intervention (post-intervention testing). Data from intervention sessions will run from enrollment to end of intervention 26 weeks later.

• Reaching data for number of reaches and amount of time reaching occurs

  Data will be collected from intervention sessions and the two functional reach assessments. Counts of the number of purposeful reaches and the extent of time (measured in seconds) the reach is maintained. Functional data will be collected from the movements made by the individual as well as from BEFORE and AFTER questionnaires to be completed by the caregivers of the participant.

  Two 60-minute assessment periods: one at baseline and one post final intervention session. Data from weekly intervention will be gathered from enrollment to 26 weeks later when intervention is complete.

Study Arms (1)

Gaming system

EXPERIMENTAL

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.

Behavioral: computer gaming

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.

Gaming system

Eligibility Criteria

• Age: 4 Years - 65 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• dx of Rett syndrome
• functional range of motion of both arms
• no seizures or seizures managed with medication
• understanding cause and effect
• midline stereotypies

You may not qualify if:

• no competing orthopedic or neuromuscular diagnosis that impacts shoulder movements

Sponsors & Collaborators

• Georgetown University: lead
• Fraunhofer Heinrich Hertz Institut (HHI): collaborator
• Max-Planck-Institute for Cognition: collaborator
• Charite University, Berlin, Germany: collaborator
• Rett Syndrome of Germany: collaborator

Study Sites (1)

Georgetown University School of Medicine

Bethesda, Maryland, 20814, United States

Location

Related Publications (3)

• McAmis NE, Foreman MH, Himmelrich MD, Diener PS and Engsberg JR. Development of a Method to Use a Color Tracker for Motor Therapy for Individuals with Rett Syndrome. SM J Pediatr. 2017; 2(2): 1012.

  BACKGROUND

• Mraz KM, Amadio G, Diener P, Eisenberg G, Engsberg JR. Improving upper extremity motor skills in girls with rett syndrome using virtual reality. J of Intellect Disabil - Diagnosis and Treatment, 2016, 4(3):142-151.

  BACKGROUND

• Mraz, K, Eisenberg G, Diener P, Amadio G, Foreman MH, Engsberg JR. The Effects of Virtual Reality on the Upper Extremity Skills of Girls with Rett Syndrome: A Single Case Study. J of Intellect Disabil- Diagnosis and Treatment. 2016, 4(3):152-9.

  BACKGROUND

MeSH Terms

Conditions

Rett Syndrome

Condition Hierarchy (Ancestors)

X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heredodegenerative Disorders, Nervous System

Study Officials

• Pamela Diener, PhD,MS,OT/L

  Georgetown 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: Co-Principal Investigator

Model Details: Customized gaming system used to improve purposeful arm use. Games are personalized based on what is motivating to the participant, so each session is personalizable. A variety of games will be available for the participant's choosing. The image or video game that the participant selected will then be projected onto the surface of a table and webcams directed at their body and programmed to detect the participant's movements will serve as the means to record what the participant is doing. Participants are typically engaged in stereotypies; such posturing will be counted as a STOP signal. As participants move their hands apart from each other or otherwise stop their unique stereotypy, the separation or reaching movements will be translated into key strokes that guide the games the participants are playing. The game play for each sessoin lasts for 15 minutes. The aim is to play at least 4 of these sessions over 7 days.

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: February 18, 2026
• Study Start: October 1, 2024
• Primary Completion: July 31, 2026
• Study Completion: July 31, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)