Measuring Impact of Computer Gaming on Arm Use in Rett Syndrome

NCT ID: NCT05012475

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2025-12-01

Brief 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. 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.

Conditions

Rett Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants

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.

Group Type: EXPERIMENTAL

Modified Virtual Reality Gaming

Intervention Type: BEHAVIORAL

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.

Interventions

Modified Virtual Reality Gaming

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Rett Syndrome Foundation Rettsyndrome.org

UNKNOWN

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Pamela Diener

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Georgetown University School of Medicine

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

Site Status: RECRUITING

Countries

United States

Central Contacts

Pamela S Diener, PhD, MS, OT/L

Role: CONTACT

psd23@georgetown.edu

2403811763

Facility Contacts

Pamela S Diener, PhD, MS, OT/L

Role: primary

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

Other Identifiers

2015-0656

Identifier Type: -

Identifier Source: org_study_id