Measuring Impact of Computer Gaming on Arm Use in Rett Syndrome

NCT05012475 | Recruiting

• 1 other identifier: 2015-0656
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Rett Syndrome

Keywords

enrichment; sensory stimulation; motor recovery; upper extremity function

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  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)

Study Arms (1)

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.

Behavioral: Modified Virtual Reality Gaming

Interventions

Modified Virtual Reality Gaming 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.

Participants

Eligibility Criteria

• Age: 4 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Rett syndrome,
• Understanding of cause and effect,
• Functional range of motion of arms to complete the movements needed to control the games.

You may not qualify if:

• no competing orthopedic or neuromuscular diagnosis that impacts shoulder movements

Sponsors & Collaborators

• Georgetown University: lead
• International Rett Syndrome Foundation Rettsyndrome.org: collaborator

Study Sites (1)

Georgetown University School of Medicine

Washington D.C., District of Columbia, 20057, United States

RECRUITING

Related Publications (3)

• 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.

  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.

  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.

  BACKGROUND

MeSH Terms

Conditions

Rett Syndrome

Condition Hierarchy (Ancestors)

X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heredodegenerative Disorders, Nervous System

Central Study Contacts

Pamela S Diener, PhD, MS, OT/L

CONTACT

2403811763; psd23@georgetown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masks needed as no direct contact will take place. This study is designed to be entirely virtual.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 19, 2021
• Study Start: May 1, 2021
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 3, 2024

Record last verified: 2024-10

Locations

US (1)