Virtual Reality Gaming for Rett Syndrome

Recruiting at 1 trial location

Overseen By Pamela S Diener, PhD, MS, OT/L

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Georgetown University

Disqualifiers: Orthopedic, neuromuscular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality gaming can help individuals with Rett syndrome improve hand and arm use while reducing repetitive movements. It also aims to determine if these changes enhance overall quality of life. Conducted online, the study allows participants to join from anywhere in the U.S. or other countries. It is best suited for those with Rett syndrome who understand cause and effect and have the arm movement needed to control the games. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve daily living for those with Rett syndrome.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this virtual reality gaming is safe for participants?

Research has shown that virtual reality (VR) gaming can be safe and beneficial for individuals with conditions like Rett Syndrome. One study found that using VR for rehabilitation improved motor skills and maintained participant engagement, indicating that VR games could provide a positive experience.

Another study found that participants playing VR games experienced less pain and fewer uncomfortable body sensations. This suggests that VR gaming might be well-tolerated and could help alleviate some symptoms.

Although detailed safety data specific to this trial is not available, VR is generally considered safe for similar applications. The absence of reported negative effects in these studies suggests it is likely a safe option for Rett Syndrome rehabilitation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using modified virtual reality gaming for Rett Syndrome because it offers a novel and interactive way to engage individuals with this condition. Unlike conventional therapies, such as medication and behavioral therapies, which can often be passive, this virtual reality approach actively involves participants in cause-and-effect training and intervention phases. This method could potentially improve motor skills and cognitive engagement by providing a stimulating and immersive environment, which holds promise for enhancing the quality of life for those with Rett Syndrome.

What evidence suggests that modified virtual reality gaming is effective for Rett syndrome?

Research has shown that virtual reality (VR) gaming, which participants in this trial will experience, can help individuals with Rett syndrome improve arm and hand movement. Studies have found that VR use can reduce repetitive movements, common in Rett syndrome. VR therapy also boosts motivation and interest, facilitating participation in rehabilitation exercises. Previous findings suggest that VR can enhance motor skills and promote more independent arm use. Overall, VR gaming appears promising for improving the quality of life for those with Rett syndrome. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with Rett Syndrome who understand cause and effect, can move their arms to control games, and have no other conditions affecting shoulder movement. It's open to participants from multiple countries and all US states.

Inclusion Criteria

You understand how one thing can lead to another.

I have been diagnosed with Rett syndrome.

I can move my arms well enough to play video games.

Exclusion Criteria

I don't have any bone or muscle conditions that affect my shoulder movement.

Timeline for a Trial Participant

Pre-intervention

Participants undergo a pre-intervention phase to establish baseline measurements

4 weeks

Cause and Effect Training

Participants engage in a cause and effect training phase to prepare for the main intervention

1 week

Intervention

Participants engage in computer-based activities designed to improve arm use and reduce stereotypies

12 weeks

3 sessions per week (virtual)

Post-intervention

Participants are assessed for changes in arm function and quality of life after the intervention

4 weeks

Follow-up

Participants are monitored for long-term effects of the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Modified Virtual Reality Gaming

Trial Overview The study tests if modified virtual reality gaming can reduce repetitive movements (stereotypies) and improve independent arm use in people with Rett Syndrome, aiming also to enhance quality of life through a tele-research approach.

How Is the Trial Designed?

Group I: Participants Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials

355

Recruited

142,000+

International Rett Syndrome Foundation Rettsyndrome.org

Collaborator

Trials

3

Recruited

230+

Published Research Related to This Trial

The Movement Rating Instrument for Virtual Reality Game Play (MRI-VRGP) was developed to quantify movements during virtual reality gaming, showing excellent reliability for many movement types, particularly for upper extremity far reach and jumping movements.

The study involved 176 gameplay sessions from 11 children (7 typically developing and 4 with cerebral palsy), and while the instrument showed strong reliability for some movements, issues like video quality and rater interpretation need to be addressed for improved accuracy in future assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Reliability Evaluation of the Movement Rating Instrument for Virtual Reality Video Game Play. Levac, D., Nawrotek, J., Deschenes, E., et al.[2020]

A systematic review of 43 studies on gaming technologies for pediatric neurorehabilitation revealed that most research consists of small-scale feasibility trials, limiting the ability to draw strong evidence-based conclusions.

The review emphasizes the need for more rigorous studies that adhere to neuroscientific principles to better understand the efficacy of gaming technologies in treating common pediatric neurological conditions like cerebral palsy and autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gaming Technology for Pediatric Neurorehabilitation: A Systematic Review. Iosa, M., Verrelli, CM., Gentile, AE., et al.[2022]

Virtual reality (VR) and interactive computer play have been effectively used in pediatric rehabilitation for over 15 years, providing engaging and realistic environments that promote active learning and motor practice.

These technologies enhance neuroplasticity and learning in children with neurological disorders by allowing for repetitive motor and sensory practice, which is crucial for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of virtual reality for cerebral palsy management. Weiss, PL., Tirosh, E., Fehlings, D.[2015]

The mobile game-based VR rehabilitation program (MoU-Rehab) significantly improved upper extremity function in stroke patients compared to conventional therapy, as measured by the Fugl-Meyer Assessment and other metrics.

The program was well-tolerated with no adverse effects reported, and patients expressed high satisfaction, indicating its feasibility as a rehabilitation tool for upper limb recovery after ischemic stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile game-based virtual reality rehabilitation program for upper limb dysfunction after ischemic stroke. Choi, YH., Ku, J., Lim, H., et al.[2019]

A new fully immersive virtual reality (VR) application for robot-assisted gait training (RAGT) was tested on 37 healthy participants, showing high usability and a low incidence of cybersickness, with 78.4% reporting no significant adverse effects.

Participants experienced a strong sense of presence in the virtual environment, indicating that the VR device is engaging and could potentially enhance rehabilitation for non-ambulatory stroke patients in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive Virtual Reality during Robot-Assisted Gait Training: Validation of a New Device in Stroke Rehabilitation. Morizio, C., Compagnat, M., Boujut, A., et al.[2023]

Virtual reality (VR) and serious games (SGs) are emerging as effective motivational tools in rehabilitation for individuals with neurological conditions, showing promise in improving body functions and some activity outcomes.

A thorough evaluation of clients' goals and careful selection of VR and SG interventions are essential for maximizing their benefits, highlighting the need for further research in areas like prevention and participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality and Serious Games in Neurorehabilitation of Children and Adults: Prevention, Plasticity, and Participation. Deutsch, JE., Westcott McCoy, S.[2019]

In a pilot study involving 11 children with cerebral palsy, the group that underwent a 1-week virtual reality (VR) intervention followed by a 6-week home active video gaming (AVG) program did not show significant improvements in gross motor skills compared to the AVG-only group.

The AVG-only group showed a significant improvement in gross motor function, while the VR + AVG group experienced a notable decrease in walking distance, indicating that the combination of VR and AVG may not be beneficial and could even be counterproductive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active Video Gaming for Children with Cerebral Palsy: Does a Clinic-Based Virtual Reality Component Offer an Additive Benefit? A Pilot Study. Levac, D., McCormick, A., Levin, MF., et al.[2018]

Involving end users, such as therapists and rehabilitation clients, in the research and implementation of virtual reality (VR) and active video games (AVGs) can significantly improve the alignment of these technologies with their needs, potentially increasing clinical uptake.

The authors identified common benefits from user engagement, including enhanced buy-in from therapists and better technology integration, while also noting challenges in balancing technology capabilities with practical rehabilitation goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

End-user involvement in rehabilitation virtual reality implementation research. Proffitt, R., Glegg, S., Levac, D., et al.[2022]

Video-game based therapy (VGT) significantly improved upper limb motor outcomes in children with cerebral palsy (CP) compared to conventional therapy (CT), as measured by the Quality of Upper Extremities Skills Test (QUEST).

Children engaged in VGT performed three times more movements than during CT, suggesting that the increased quantity of movements contributed to the improvement in motor skills, although CT was more effective for enhancing manual abilities for daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video-game based therapy performed by children with cerebral palsy: a cross-over randomized controlled trial and a cross-sectional quantitative measure of physical activity. Zoccolillo, L., Morelli, D., Cincotti, F., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-rett-syndrome-4-2021-13625

Virtual Reality Gaming for Rett Syndrome This trial uses special computer games with wristbands to help individuals with Rett syndrome move their arms and hands more independently.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12030142/

Virtual Reality as a Tool for Upper Limb Rehabilitation in ... The findings support the VR intervention's efficacy, showing improvements in motor skills, reduction in stereotypical behaviors, and enhanced ...

3. researchgate.net researchgate.net/publication/377873390_The_use_of_virtual_reality_in_Rett_Syndrome_rehabilitation_to_improve_the_learning_motivation_and_upper_limb_motricity_A_pilot_study

The use of virtual reality in Rett Syndrome rehabilitation to ... Conclusions: This study demonstrates the potential of VR as a tool for RTT rehabilitation, addressing both motor and engagement challenges.

4. pdfs.semanticscholar.org pdfs.semanticscholar.org/cf06/31fb09b406c17516d3fd74160a4b31263026.pdf

The Effects of Virtual Reality on the Upper Extremity Skills ... An effective way to increase motivation for therapy and enhance the frequency, duration, and intensity of therapy movements is the use of VR and gaming therapy ...

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05012475?keyword=%22Upper%20Extremity%20Function%22

Measuring Impact of Computer Gaming on Arm Use in Rett ... 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11571987/

Virtual Reality Gaming in Occupational Rehabilitation The participants experienced symptom relief while playing VR games, such as relief from pain, unpleasant body sensations, and mental symptoms ...

7. mdpi.com mdpi.com/2227-9067/11/9/1110

Effects of Immersive Virtual Reality with Treadmill in ... The aim of this study was to assess the feasibility of a short treadmill training coupled to VR in girls with Rett syndrome.