Telehealth Support to Increase Physical Activity in Rett Syndrome

Rett Syndrome Clinical Trial

— ActivRett  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04167059
• Other study ID #: RGS0000003371
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: February 2020
• Source: Telethon Kids Institute
• Contact: Jenny Downs, PhD
• Phone: +61 8 6319 1763
• Email: Jenny.Downs[@]telethonkids.org.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Rett Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Denmark	Center for Rett Syndrom, Rigshospitalet	Copenhagen
Israel	Ari'el University	Ari'el

Sponsors (4)

Lead Sponsor	Collaborator
Telethon Kids Institute	Ariel University, Rigshospitalet, Denmark, University of Haifa

Countries where clinical trial is conducted

Denmark,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average daily uptime (%)	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
Primary	Average daily step count	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	Sleep quality	Sleep Disturbance Scale for Children.	Parent caregiver recall over previous month, data capture at baseline, after 12 weeks and after 24 weeks
Secondary	Behaviour	Rett Syndrome Behaviour Scale	Parent caregiver recall over previous month, data capture at baseline, after 12 weeks and after 24 weeks
Secondary	Child Quality of Life	Quality of Life Inventory-Disability (QI-Disability)	Parent caregiver recall over previous month, data capture at baseline, after 12 weeks and after 24 weeks