Technology-supported Motor Rehabilitation for People With Rett Syndrome (TeMoRett)

February 18, 2026 updated by: Pamela Diener, Georgetown University

Technology-supported Motor Rehabilitation for People With Rett Syndrome (TeMoRett) Sub-project: Psychophysiological Personalization of the Technology-supported Motor Rehabilitation for People With Rett Syndrome

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Baseline measurements taken at start of study. Training occurs for separation tasks for the first 13 weeks, with four 15-min sessions running per week. To gradually improve in ability to control gaming with arms/hands, each participant has the option of trying 13 levels or challenges on the extent of separation (how far apart hands can be taken.) Training occurs for the final 13 weeks for reaching tasks. Here, the participant must separate hands and reach for a defined target in order to initiate game play. These sessions will also last 15 minutes each and four sessions will be required per week.

At the conclusion of the 26 weeks of training, the measurements of functional arm/hand use, and other behavioral measurements taken at Baseline will be repeated and compared to Baseline to assist in determining the success of the gaming used to train purposeful and functional arm use.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Georgetown University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • no competing orthopedic or neuromuscular diagnosis that impacts shoulder movements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: computer gaming
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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)
Time Frame: 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.
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
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Georgetown University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Charite University, Berlin, Germany
Fraunhofer Heinrich Hertz Institut (HHI)
Max-Planck-Institute for Cognition
Rett Syndrome of Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pamela Diener, PhD,MS,OT/L, Georgetown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.
  • 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.
  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13GW0488B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Publications resulting from the study will be the means by which the outcomes of the study and details of participants within in (coded to maintain confidentiality) be disseminated.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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