Telehealth Support to Increase Physical Activity in Rett Syndrome (ActivRett)

February 2, 2020 updated by: Telethon Kids Institute

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

60

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

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

5 years to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Waitlist-Control Group
The 'waitlist control' group will receive the 12-week non-intervention period first, followed by 12 week intervention period.
Behavioral: Telehealth-delivered participation strategies to increase physical activity
Therapists and primary caregivers will meet online on 6 occasions at fortnightly intervals over a 12 week period. Sessions will enable the development of strategies that will aim to increase the amount the participant stands and walks. Throughout, the therapists and primary caregivers will discuss physical activity needs, determine relevant activities, modify the program as necessary and plan additional goals.
EXPERIMENTAL: Immediate Treatment
The 'immediate treatment' group will receive the 12-week intervention period first, followed by 12 week non-intervention period.
Behavioral: Telehealth-delivered participation strategies to increase physical activity
Therapists and primary caregivers will meet online on 6 occasions at fortnightly intervals over a 12 week period. Sessions will enable the development of strategies that will aim to increase the amount the participant stands and walks. Throughout, the therapists and primary caregivers will discuss physical activity needs, determine relevant activities, modify the program as necessary and plan additional goals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average daily uptime (%)
Time Frame: Average over 4 days, data capture at baseline, after 12 weeks and after 24 weeks
Percentage of time spent active (uptime) over total awake time, measured with an ActivPAL
Average over 4 days, data capture at baseline, after 12 weeks and after 24 weeks
Average daily step count
Time Frame: Average over 4 days, data capture at baseline, after 12 weeks and after 24 weeks
Number of daily steps measured by Stepwatch Activity Monitor
Average over 4 days, data capture at baseline, after 12 weeks and after 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep quality
Time Frame: Parent caregiver recall over previous month, data capture at baseline, after 12 weeks and after 24 weeks
Sleep Disturbance Scale for Children.
Parent caregiver recall over previous month, data capture at baseline, after 12 weeks and after 24 weeks
Behaviour
Time Frame: Parent caregiver recall over previous month, data capture at baseline, after 12 weeks and after 24 weeks
Rett Syndrome Behaviour Scale
Parent caregiver recall over previous month, data capture at baseline, after 12 weeks and after 24 weeks
Child Quality of Life
Time Frame: Parent caregiver recall over previous month, data capture at baseline, after 12 weeks and after 24 weeks
Quality of Life Inventory-Disability (QI-Disability)
Parent caregiver recall over previous month, data capture at baseline, after 12 weeks and after 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Telethon Kids Institute

Collaborators

Rigshospitalet, Denmark
University of Haifa
Ariel University

Investigators

  • Principal Investigator: Jenny Downs, PhD, Telethon Kids Institute

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

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)

January 1, 2020

Primary Completion (ANTICIPATED)

September 1, 2020

Study Completion (ANTICIPATED)

September 1, 2021

Study Registration Dates

First Submitted

November 14, 2019

First Submitted That Met QC Criteria

November 14, 2019

First Posted (ACTUAL)

November 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 2, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGS0000003371

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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