Recruiting

Observational Study

Sponsor:

Georgetown University

Code:

NCT05012475

Conditions

Rett Syndrome

Eligibility Criteria

Sex: All

Age: 4 - 60

Healthy Volunteers: Not accepted

Interventions

Modified Virtual Reality Gaming

Study Details

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

Study ID

NCT05012475

Start date

May 1, 2021

Status verified date

Oct, 2024

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Jun 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

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.

Primary outcome measure

  • functional Reach Test [ Time Frame: 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). ]

Central Contacts and Locations

Central contacts

Pamela S Diener, PhD, MS, OT/L

2403811763psd23@georgetown.edu

Locations

Georgetown University School of Medicine

Recruiting

Washington, District of Columbia, United States, 20057

More Information

Sponsor

Georgetown University

Last update posted

Oct 3, 2024

Last verified

Oct, 2024

Keywords

  • enrichment
  • sensory stimulation
  • motor recovery
  • upper extremity function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgetown University on 2024-10-03.