Virtual Reality Gaming for Rett Syndrome

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

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Georgetown University

Disqualifiers: Orthopedic, neuromuscular, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial uses special computer games with wristbands to help individuals with Rett syndrome move their arms and hands more independently. The wristbands track arm movements, allowing participants to control the games. The goal is to reduce repetitive hand movements and improve quality of life.

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 data supports the effectiveness of the treatment Modified Virtual Reality Gaming, Virtual Reality Gaming, Computer-Based Gaming Therapy for Rett Syndrome?

Research shows that virtual reality and game-based therapies can improve motivation and engagement in rehabilitation for neurological conditions, and they have been used effectively in children with cerebral palsy and adults after strokes. These therapies provide repetitive, task-oriented training that can enhance learning and neuroplasticity (the brain's ability to reorganize itself), which may be beneficial for individuals with Rett Syndrome. ^{1 2 3 4 5}

Is virtual reality gaming safe for use in humans?

Research on virtual reality gaming for rehabilitation, including for conditions like stroke and cerebral palsy, shows that it is generally safe for humans, with most participants experiencing no significant adverse effects. ^{1 3 5 6 7}

How is the treatment 'Virtual Reality Gaming for Rett Syndrome' different from other treatments for this condition?

Virtual Reality Gaming for Rett Syndrome is unique because it uses interactive simulations to create engaging and realistic environments for active learning and rehabilitation, which can promote neuroplasticity (the brain's ability to reorganize itself) and sensory/motor practice, unlike traditional therapies that may not offer such immersive and motivating experiences. ^{1 4 7 8 9}

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Modified Virtual Reality Gaming (Behavioral Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Development and Reliability Evaluation of the Movement Rating Instrument for Virtual Reality Video Game Play. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile game-based virtual reality rehabilitation program for upper limb dysfunction after ischemic stroke. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality and Serious Games in Neurorehabilitation of Children and Adults: Prevention, Plasticity, and Participation. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Role of virtual reality for cerebral palsy management. [2015]

5. England pubmed.ncbi.nlm.nih.gov

End-user involvement in rehabilitation virtual reality implementation research. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Immersive Virtual Reality during Robot-Assisted Gait Training: Validation of a New Device in Stroke Rehabilitation. [2023]

7. England 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. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Gaming Technology for Pediatric Neurorehabilitation: A Systematic Review. [2022]

9. Italy 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. [2022]