Telehealth Support to Increase Physical Activity in Rett Syndrome

Not Applicable

• Conditions: Rett Syndrome
• Interventions: Behavioral: Telehealth-delivered participation strategies to increase physical activity

• Registration Number: NCT04167059
• Lead Sponsor: Telethon Kids Institute

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 Timeline

• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-14
• Study First Posted: 2019-11-18
• Study Start: 2020-01-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-02
• Last Update Posted: 2020-02-05
• Primary Completion: 2020-09-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Waitlist-Control Group	Telehealth-delivered participation strategies to increase physical activity	The 'waitlist control' group will receive the 12-week non-intervention period first, followed by 12 week intervention period.
Immediate Treatment	Telehealth-delivered participation strategies to increase physical activity	The 'immediate treatment' group will receive the 12-week intervention period first, followed by 12 week non-intervention period.

Primary Outcome Measures

Name	Time	Method
Average daily uptime (%)	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 daily step count	Average over 4 days, data capture at baseline, after 12 weeks and after 24 weeks	Number of daily steps measured by Stepwatch Activity Monitor

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Center for Rett Syndrom, Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Ari'el University; 🇮🇱 Ari'el, Israel