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Measuring Impact of Computer Gaming on Arm Use in Rett Syndrome

Primary Purpose

Rett Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modified Virtual Reality Gaming
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rett Syndrome focused on measuring enrichment, sensory stimulation, motor recovery, upper extremity function

Eligibility Criteria

4 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Georgetown University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 4, 2021
Last Updated
February 21, 2023
Sponsor
Georgetown University
Collaborators
International Rett Syndrome Foundation Rettsyndrome.org
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1. Study Identification

Unique Protocol Identification Number
NCT05012475
Brief Title
Measuring Impact of Computer Gaming on Arm Use in Rett Syndrome
Official Title
Assessing the Effectiveness of Customized Computer Activities on Reducing Stereotypies and Improving Independent Upper Extremity Motor Skills in Persons With Rett Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgetown University
Collaborators
International Rett Syndrome Foundation Rettsyndrome.org

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rett Syndrome
Keywords
enrichment, sensory stimulation, motor recovery, upper extremity function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
No masks needed as no direct contact will take place. This study is designed to be entirely virtual.
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Modified Virtual Reality Gaming
Intervention Description
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 Information:
Title
functional Reach Test
Description
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 Outcome Measure Information:
Title
Goal Attainment Scale (GAS)
Description
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)
Title
Functional Range of Motion (FROM)
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela S Diener, PhD, MS, OT/L
Phone
2403811763
Email
psd23@georgetown.edu
Facility Information:
Facility Name
Georgetown University School of Medicine
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela S Diener, PhD, MS, OT/L

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
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Citation
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.
Results Reference
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Citation
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.
Results Reference
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Measuring Impact of Computer Gaming on Arm Use in Rett Syndrome

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