Rett SyndromeNCT05012475
Measuring Impact of Computer Gaming on Arm Use in Rett Syndrome
A study testing Modified Virtual Reality Gaming in people with Rett Syndrome, run by Georgetown University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 60 years
- Conditions the study is for
- Rett Syndrome
- What is being tested?
- Modified Virtual Reality Gaming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 1 Feb 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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Rett syndrome,
- Understanding of cause and effect,
- Functional range of motion of arms to complete the movements needed to control the games.
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
Washington D.C., District of Columbia, 20057
About this study
Official title: Assessing the Effectiveness of Customized Computer Activities on Reducing Stereotypies and Improving Independent Upper Extremity Motor Skills in Persons With Rett Syndrome
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.
Read the detailed description
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.
- Conditions
- Rett Syndrome
- Being tested
- Modified Virtual Reality Gaming
- Keywords
- enrichment, sensory stimulation, motor recovery, upper extremity function
- Medical subject headings
- Rett Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Virtual Reality GamingBehavioural
Investigators customize each gaming session based on the motivators and interests of each participant. The intervention facilitates independent hand separations (minimizing stereotypies) and encourages independent arm/hand movement that serves to activate or control the computer-generated activities.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | The study involves a pre-intervention phase (4 weeks long), followed by a cause and effect training phase (1 week long), followed by an intervention phase (12 weeks long), and ending with a post-intervention phase (4-weeks long) for a total of 5-6 months from start to finish. Receives: Behavioral: Modified Virtual Reality Gaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional Reach Test
Investigators will video record all testing sessions so that the video can be viewed slow motion or frame by frame to count hand separations, number of reaches, time of sustained reaches, and sustained hand separations.
Measured: To measure change, this test is administered (repeated) 5 times during the 5 month study: Day 1 (baseline); Day 32 (start of wk long training); Day 40 (after one wk training session); Day Day 130 (end of 12 wk intervention); Day 160 (post-intervention).
Secondary outcomes (2)
Goal Attainment Scale (GAS)
In collaboration with the parents/carers, investigators will create three goals specific for each participant that relate to study aims and improving quality of daily living.
Measured: To measure change, this test is administered on Day 1 (Baseline) and repeated at Day 120 (end of intervention phase)
Functional Range of Motion (FROM)
Assess range of shoulder and hand motion at start and at end of study to be sure that shoulder mobility is unchanged and/or not impacting the required motions for the intervention.
Measured: To assess if a change in FROM occurs during the study, this test is administered on Day 1 (Baseline) and repeated at Day 120 (Post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 May 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Feb 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
- Investigators accept individuals with Rett syndrome who meet the inclusion criteria that requires functional arm range of motion, understanding of cause and effect and a diagnosis of Rett syndrome.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- International Rett Syndrome Foundation
- Responsible party
- Principal investigator, Pamela Diener, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012475
- Sponsor's protocol ID
- 2015-0656
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2021
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Assessing the Effectiveness of Customized Computer Activities on Reducing Stereotypies and Improving Independent Upper Extremity Motor Skills in Persons With Rett Syndrome
- ClinicalTrials.gov ID
- NCT05012475
- Acronym / sponsor ID
- 2015-0656
- Conditions
- Rett Syndrome
- Keywords
- enrichment, sensory stimulation, motor recovery, upper extremity function
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- International Rett Syndrome Foundation
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 19 Aug 2021 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Investigators accept individuals with Rett syndrome who meet the inclusion criteria that requires functional arm range of motion, understanding of cause and effect and a diagnosis of Rett syndrome.
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Behavioral: Modified Virtual Reality GamingThe study involves a pre-intervention phase (4 weeks long), followed by a cause and effect training phase (1 week long), followed by an intervention phase (12 weeks long), and ending with a post-intervention phase (4-weeks long) for a total of 5-6 months from start to finish. |
Who may qualify
- Ages
- 4 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Rett syndrome,
- Understanding of cause and effect,
- Functional range of motion of arms to complete the movements needed to control the games.
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 |
|---|---|---|
| Modified Virtual Reality GamingInvestigators customize each gaming session based on the motivators and interests of each participant. The intervention facilitates independent hand separations (minimizing stereotypies) and encourages independent arm/hand movement that serves to activate or control the computer-generated activities. | Behavioural | Participants |
Primary outcome
functional Reach Test
Time frame: To measure change, this test is administered (repeated) 5 times during the 5 month study: Day 1 (baseline); Day 32 (start of wk long training); Day 40 (after one wk training session); Day Day 130 (end of 12 wk intervention); Day 160 (post-intervention).
Investigators will video record all testing sessions so that the video can be viewed slow motion or frame by frame to count hand separations, number of reaches, time of sustained reaches, and sustained hand separations.
2 secondary outcomes
Goal Attainment Scale (GAS)
Time frame: To measure change, this test is administered on Day 1 (Baseline) and repeated at Day 120 (end of intervention phase)
Functional Range of Motion (FROM)
Time frame: To assess if a change in FROM occurs during the study, this test is administered on Day 1 (Baseline) and repeated at Day 120 (Post-intervention)
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Virtual Reality 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 3 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?
functional Reach Test (time frame: To measure change, this test is administered (repeated) 5 times during the 5 month study: Day 1 (baseline); Day 32 (start of wk long training); Day 40 (after one wk training session); Day Day 130 (end of 12 wk intervention); Day 160 (post-intervention).). 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 NCT05012475, 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.