Measuring Impact of Computer Gaming on Arm Use in Rett Syndrome

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT05012475
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
4 Years - 60 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
May 1, 2021
Status verified
Oct 2024
Primary completion
Jun 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Georgetown University School of MedicineWashington D.C.District of Columbia20057
Pamela S Diener, PhD, MS, OT/L

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Georgetown University School of Medicine· Washington D.C., DC

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