Measuring Impact of Computer Gaming on Arm Use in Rett Syndrome

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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

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.
    


Study Type

Interventional


Primary Outcome

functional Reach Test

Secondary Outcome

 Goal Attainment Scale (GAS)

Condition

Rett Syndrome

Intervention

Modified Virtual Reality Gaming

Study Arms / Comparison Groups

 Participants
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

10

Start Date

May 1, 2021

Completion Date

May 1, 2023

Primary Completion Date

December 1, 2022

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
      

Gender

All

Ages

4 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

, 2403811763, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05012475

Organization ID

2015-0656


Responsible Party

Principal Investigator

Study Sponsor

Georgetown University

Collaborators

 International Rett Syndrome Foundation Rettsyndrome.org

Study Sponsor

, , 


Verification Date

August 2021