ClinicalTrials.gov record NCT05012475

Measuring Impact of Computer Gaming on Arm Use in Rett Syndrome

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Assessing the Effectiveness of Customized Computer Activities on Reducing Stereotypies and Improving Independent Upper Extremity Motor Skills in Persons with Rett Syndrome

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Oct 3, 2024, about 2 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age4 years old to 60 years old
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This single-group treatment study tests a home-based, customized computer-gaming program for people with Rett Syndrome. Participants are guided remotely and play games while wearing brightly colored wristbands for about one hour, three days per week during a roughly 12-week intervention within a 5–6 month study schedule. Investigators will measure hand movements and family-centered daily-living goals before, during, and after the intervention.

What it is studying. The study tests whether caregiver-guided, customized computer activities (modified virtual reality) change hand stereotypies and increase the amount and quality of independent arm and hand movement in people with Rett Syndrome. It also evaluates effects on three family-developed daily-living goals and monitors shoulder/hand range of motion.

What the researchers hope to learn. To learn whether customized, caregiver-guided computer gaming reduces hand stereotypies, increases independent and sustained arm/hand reaching, and affects family-centered daily-living goals; to document any changes in shoulder/hand range of motion.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Using a tele-research approach, we will recruit, enroll, guide and support carers and participants to engage in computer based activities (modified virtual reality) with the primary outcome of reducing stereotypies and increasing independent arm and hand use and secondary outcome of improving quality of living. Because of our virtual approach, we are able to recruit from multiple countries and all states and territories of the USA.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Behavioral
  • Modified Virtual Reality Gaming

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Rett syndrome,
  • Understanding of cause and effect,
  • Functional range of motion of arms to complete the movements needed to control the games.

Exclusion criteria

  • no competing orthopedic or neuromuscular diagnosis that impacts shoulder movements

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Early in life, individuals with Rett syndrome lose purposeful use of their hands and engage in handwringing and handmouthing stereotypies. It is important to pursue interventions that may facilitate the development and sustained use of arms/hands for productive involvement in daily needs that ultimately improve quality of life. Investigators plan to use a tele-research approach to assist caregivers and the participants in playing customized computer generated games that require independent and sustained hand separations and initiated and sustained movement patterns to control the modified virtual reality activity that serves as our intervention. Customization of the games and activities used will require collaboration with the caregivers of each participant to ensure that the level of motivation and interest of the participant matches the game/activities used. Brightly colored wristbands will be worn on each participant's wrist during the one-hour long intervention in which they will be involved 3 days per week for ~12 weeks. These wrist bands will be detected by the software we developed. As the participants move their arms, our software will detect these position changes and activate the computer-based activities. At 5 different points in the study investigators will test for changes in independent reaching abilities that may result from exposure to the intervention. Specifically, investigators will assess the impact of the intervention on minimizing hand stereotypies and improving the amount and quality of independent arm function. At the start and end of the study, investigators will also assess the impact the intervention had on activities of daily living, and therefore quality of life, via three goals developed in collaboration with the family/caregiver of the participant. Due to the virtual nature (tele-research) of the study, investigators aim to recruit 10-12 participants from multiple countries. Once enrolled, each participant will remain involved for up to 5-6 months. Since all activities are hand selected for each participant in collaboration with the caregivers, risks of involvement in this study are low. Investigators anticipate that this intervention will improve motor planning abilities for arm use and reduce stereotypies.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are involved for about 5–6 months: a 4-week pre-intervention phase, a 1-week training phase, a 12-week intervention phase, and a 4-week post-intervention phase. Using a remote (tele-research) approach, the study team will guide caregivers and participants to play customized computer-based (modified virtual reality) games for about one hour per session, three days per week during the intervention; brightly colored wristbands worn on each wrist let the software detect arm movements. Investigators will video-record reach testing at five time points to count reaches and hand separations, and will assess three caregiver-selected goals (Goal Attainment Scale) and functional range of motion at the start and end of the study. Game selection and session settings are customized in collaboration with the caregiver.

How the study is structured. Interventional, single-group (no comparison group), unblinded study delivered remotely. Participants complete a 4-week pre-intervention period, a 1-week training period, a 12-week intervention (about one hour per session, three days per week), and a 4-week post-intervention follow-up for a total of about 5–6 months. Outcomes include repeated, video-recorded functional reach testing (five time points) and goal and range-of-motion assessments at the start and end. Investigators plan to enroll about 10–12 participants.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Rett syndrome

Clinical trials20 trials listed for Rett syndromeEvery trial the registry lists for Rett syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Rett syndrome researchLatest monthly update: September 2026. Includes: Seizure add-on drug. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 1, 2021
Primary completion
Jun 1, 2025 (estimated)
Study completion
Dec 1, 2025 (estimated)
Target enrollment
10 participants (estimated)
Last updated on registry
Oct 3, 2024
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Georgetown University
Principal investigator
Pamela Diener, Professor
Georgetown University
Collaborators
  • International Rett Syndrome Foundation

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Georgetown University School of MedicineRecruiting

    Washington D.C., District of Columbia, 20057 · United States

    • Pamela S Diener, PhD, MS, OT/L

Terms used on this page · explanations by MedicalUpdates.ai

primary outcome
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
secondary outcome
An additional result the study measures alongside the primary outcome, for example quality of life or a laboratory value.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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