Telehealth Support to Increase Physical Activity in Rett Syndrome

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Brief Title

Telehealth Support to Increase Physical Activity in Rett Syndrome

Official Title

Implementing Telehealth Support to Increase Physical Activity in Girls and Women With Rett Syndrome

Brief Summary

      This study will recruit families with a daughter with Rett syndrome living in either
      Australia, Denmark or Israel, and thereafter deliver individually designed participation
      programs using telehealth strategies. We will evaluate the effectiveness of the programs on
      reducing sedentary behaviours, increasing physical activity and increasing quality of life.
    

Detailed Description

      This project will implement two intertwined strategies that will build the capacity of the
      carer, clinical and therapy communities to support physical activity in Rett syndrome.
      Individuals with Rett syndrome experience difficulties with movement and this can make it
      difficult to participate in regular physical activity. Individuals with Rett syndrome need
      support to participate in physical activities and it is important to work with primary
      caregivers when developing strategies to support physical activity. We will conduct a
      clinical trial that tests the effectiveness of working with primary caregivers to develop
      strategies suitable to their lives that aim to increase participation in physical activity in
      the individual with Rett syndrome whom they support. We will use a clinical trial design and
      work with primary caregivers using Telehealth. We will test whether this approach decreases
      sedentary time and increases physical activity. We will also test if there are changes in the
      sleep, behaviour and quality of life. We aim to recruit 60 families for this study, 26 of
      whom will live in Australia. Data from the three sites will be pooled for a stronger
      analysis. We acknowledge that physical activity can be associated with a fall and therefore
      our program will be developed with the primary caregiver to be suitable for their lives and
      capacity to provide support. However, by practicing more activity, the individuals with Rett
      syndrome could be stronger and risks of falling could be reduced. The risks for the
      individual with Rett syndrome are therefore low. To let the Rett syndrome community know our
      results, we will then develop an online resource documenting the physical activity program
      and the evidence available to support it, and this will be freely available to families,
      carers and therapists wherever they live in the world.
    


Study Type

Interventional


Primary Outcome

Average daily uptime (%)

Secondary Outcome

 Sleep quality

Condition

Rett Syndrome

Intervention

Telehealth-delivered participation strategies to increase physical activity

Study Arms / Comparison Groups

 Waitlist-Control Group
Description:  The 'waitlist control' group will receive the 12-week non-intervention period first, followed by 12 week intervention period.

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

60

Start Date

January 1, 2020

Completion Date

September 1, 2021

Primary Completion Date

September 1, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Genetically confirmed Rett syndrome

          -  Able to stand (with or without assistance)

          -  Live in Australia, Denmark or Israel

        Exclusion Criteria:

          -  Individuals who have had spinal fusion over the previous 12 months

          -  Individuals who have had lower extremity orthopaedic surgery over the previous 6
             months
      

Gender

All

Ages

5 Years - 40 Years

Accepts Healthy Volunteers

No

Contacts

Jenny Downs, PhD, +61 8 6319 1763, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT04167059

Organization ID

RGS0000003371


Responsible Party

Sponsor

Study Sponsor

Telethon Kids Institute

Collaborators

 Rigshospitalet, Denmark

Study Sponsor

Jenny Downs, PhD, Principal Investigator, Telethon Kids Institute


Verification Date

February 2020