- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05012475
Measuring Impact of Computer Gaming on Arm Use in Rett Syndrome
February 21, 2023 updated by: Pamela Diener, Georgetown University
Assessing the Effectiveness of Customized Computer Activities on Reducing Stereotypies and Improving Independent Upper Extremity Motor Skills in Persons With Rett Syndrome
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
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Washington, District of Columbia, United States, 20057
- Recruiting
- Georgetown University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Goal Attainment Scale (GAS)
Time Frame: To measure change, this test is administered on Day 1 (Baseline) and repeated at Day 120 (end of intervention phase)
|
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.
|
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)
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)
|
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.
|
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)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2021
Primary Completion (Anticipated)
May 1, 2024
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
August 4, 2021
First Submitted That Met QC Criteria
August 12, 2021
First Posted (Actual)
August 19, 2021
Study Record Updates
Last Update Posted (Estimate)
February 23, 2023
Last Update Submitted That Met QC Criteria
February 21, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-0656
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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