Health TrialsbyHealthPanel

Measuring Impact of Computer Gaming on Arm Use in Rett Syndrome

ConditionRett Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-60
SponsorGeorgetown University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Rett syndrome,

Understanding of cause and effect,

Functional range of motion of arms to complete the movements needed to control the games.

Disqualifiers

no competing orthopedic or neuromuscular diagnosis that impacts shoulder movements

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: ParticipantsExperimental treatment 1 intervention

Trial outcomes

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.

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).

Secondary outcomes

1

Goal Attainment Scale (GAS)

In collaboration with the parents/carers, investigators will create three goals specific for each participant that relate to study aims and improving quality of daily living.

Time frame
To measure change, this test is administered on Day 1 (Baseline) and repeated at Day 120 (end of intervention phase)
2

Functional Range of Motion (FROM)

Assess range of shoulder and hand motion at start and at end of study to be sure that shoulder mobility is unchanged and/or not impacting the required motions for the intervention.

Time frame
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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Georgetown University

Lead sponsor

International Rett Syndrome Foundation

Collaborator

Source ClinicalTrials.gov
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