Rett SyndromeTeMoRettNCT07418905
Technology-supported Motor Rehabilitation for People With Rett Syndrome
A study testing computer gaming in people with Rett Syndrome, run by Georgetown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 65 years, women only
- Conditions the study is for
- Rett Syndrome
- What is being tested?
- computer gaming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- dx of Rett syndrome
- functional range of motion of both arms
- no seizures or seizures managed with medication
- understanding cause and effect
- midline stereotypies
Who cannot join
- no competing orthopedic or neuromuscular diagnosis that impacts shoulder movements
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University School of Medicine
Bethesda, Maryland, 20814
About this study
Official title: 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.
Read the 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.
- Conditions
- Rett Syndrome
- Being tested
- computer gaming
- Keywords
- habilitation, recovery of function, purposeful arm use, gaming
- Medical subject headings
- Rett Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer gamingBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: computer gaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Oct 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rett SyndromeStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Fraunhofer Heinrich Hertz Institut (HHI), Max-Planck-Institute for Cognition, Charite University, Berlin, Germany, Rett Syndrome of Germany
- Responsible party
- Principal investigator, Pamela Diener, Georgetown University
- Investigators
- Pamela Diener, PhD,MS,OT/L, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418905
- Sponsor's protocol ID
- 13GW0488B
- Acronym
- TeMoRett
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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 at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07418905
- Acronym / sponsor ID
- TeMoRett / 13GW0488B
- Conditions
- Rett Syndrome
- Keywords
- habilitation, recovery of function, purposeful arm use, gaming
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Fraunhofer Heinrich Hertz Institut (HHI), Max-Planck-Institute for Cognition, Charite University, Berlin, Germany, Rett Syndrome of Germany
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Gaming system | Experimental | Behavioral: computer gamingThe 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. |
Who may qualify
- Ages
- 4 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- dx of Rett syndrome
- functional range of motion of both arms
- no seizures or seizures managed with medication
- understanding cause and effect
- midline stereotypies
Key exclusion criteria (1 listed)
- no competing orthopedic or neuromuscular diagnosis that impacts shoulder movements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computer gamingInvestigators 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. | Behavioural | Gaming system |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- BackgroundMcAmis 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.
- BackgroundMraz 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.
- BackgroundMraz, 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Rett Syndrome
RecruitingPhase 3
A Phase 3 Study of Fenfluramine Hydrochloride in Rett Syndrome
Rett Syndrome
Active, not recruiting
Measuring Impact of Computer Gaming on Arm Use in Rett Syndrome
Rett Syndrome
RecruitingObservational study
Neurophysiologic Biomarkers in Rett Syndrome
Rett Syndrome, RTT
RecruitingPhase 1/2
ATTUNE: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally-Administered ION440 in Participants With Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome (MDS)
Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome
Active, not recruiting
Web Intervention for Parents of Youth With Genetic Syndromes (WINGS)
Telomeric 22Q13 Monosomy Syndrome, Tuberous Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Diener, PhD,MS,OT/L principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computer gaming in people with Rett Syndrome, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07418905, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.