What side effects are associated with this type of intervention?

Common treatments for Rett Syndrome that focus on improving motor function and reducing stereotypies include physical therapy, occupational therapy, and interactive computer-based activities like modified virtual reality. Known side effects of these treatments are generally minimal but can include temporary fatigue, muscle soreness, and frustration or anxiety due to the challenges of the activities. These interventions are considered safe and are designed to enhance the quality of life and functional abilities of individuals with Rett Syndrome.

What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically for the treatment of Rett Syndrome. However, various symptomatic treatments are used to manage the condition, including medications for seizures, motor difficulties, and breathing irregularities. The trial involving modified virtual reality aims to reduce stereotypies and improve motor function, which is a novel approach not yet reflected in current FDA-approved treatments for Rett Syndrome.

What other types of research exist?

Promising novel alternatives to Modified Virtual Reality for Rett Syndrome patients include: 1) Music therapy, which has been shown to improve social interaction and communication skills. 2) Therapeutic horseback riding, which can enhance social functioning and motor skills. 3) Transcranial Magnetic Stimulation (TMS), which has potential benefits for neurological and motor function. 4) Sensory integration therapies, which target sensory processing issues and can improve motor skills and behavior. 5) Parent-mediated interventions, which involve caregivers in therapeutic activities to enhance engagement and outcomes.

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Behavioral Intervention

Virtual Reality Gaming for Rett Syndrome

N/A

Recruiting

Research Sponsored by Georgetown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Rett syndrome

Be younger than 65 years old

Must not have

No competing orthopedic or neuromuscular diagnosis that impacts shoulder movements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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).

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves computer-based activities without medication or invasive procedures, significant side effects are not anticipated. However, fatigue or frustration may occur due to game challenges.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with Rett syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

functional Reach Test

Secondary study objectives

Functional Range of Motion (FROM)

Goal Attainment Scale (GAS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ParticipantsExperimental Treatment1 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.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Rett Syndrome include physical, occupational, and communication therapies, which aim to improve motor function, balance, and purposeful hand use. These therapies often involve multimodal approaches such as traditional physiotherapy, hydrotherapy, music therapy, and computerized systems. The mechanisms of action typically involve promoting neuroplasticity, enhancing motor learning, and reducing repetitive hand movements through structured, engaging activities. For instance, virtual reality-based interventions can provide interactive and stimulating environments that encourage movement and cognitive engagement, which are crucial for improving motor function and reducing stereotypies in Rett Syndrome patients. These treatments matter because they help preserve autonomy, improve quality of life, and enhance social interaction for individuals with Rett Syndrome.

Balance rehabilitation with a virtual reality protocol for patients with hereditary spastic paraplegia: Protocol for a clinical trial.Integration of Motor Learning Principles Into Virtual Reality Interventions for Individuals With Cerebral Palsy: Systematic Review.