Home-based exercise program for children with ataxia telangiectasia
Exploring Effectiveness, Feasibility, and Acceptability of a Novel Home-based Complex Intervention for Children With Ataxia Telangiectasia: a Pilot Randomised Controlled Trial
This study is testing a home exercise program to see if it can help children with ataxia telangiectasia improve their fitness and health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 4 Years to 11 Years |
| Sex | All |
| Sponsor | University of Plymouth Academic / other |
| Locations | 1 site (Plymouth) |
| Trial ID | NCT05692622 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness, feasibility, and acceptability of a home-based complex exercise intervention designed for children diagnosed with ataxia telangiectasia (A-T). The intervention includes whole-body and respiratory exercises tailored to improve fitness and overall health in this population. Developed in collaboration with families, therapists, and researchers, the program seeks to address the unique challenges faced by children with A-T, who often require multi-disciplinary care. The study will assess how well these interventions can be integrated into daily life and their impact on managing symptoms of A-T.
Who should consider this trial
Good fit: Ideal candidates are children aged 4-11 years with a clinically confirmed diagnosis of ataxia telangiectasia who can walk independently.
Not a fit: Patients with significant intellectual disabilities or those currently undergoing cancer therapies may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could enhance the quality of life and physical health of children with ataxia telangiectasia.
How similar studies have performed: While there is limited evidence on similar interventions specifically for A-T, the approach of home-based exercise programs has shown promise in other pediatric populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of A-T confirmed clinically * Aged 4-11 years * Able to walk independently (with no or only intermittent support) over 10 metres and stand unaided for 1 minute * Able to communicate in English either independently or with the assistance of their parent/legal guardian (where parent/guardian is able to communicate in English) or using a translator arranged by the participating family * Has the ability to assent and parents/legal guardians have the ability to give consent on their child's behalf Exclusion Criteria: * Those with other/additional diagnoses thought by the study team to probably compromise the intervention, e.g. with significant intellectual disability * Currently undergoing cancer therapies or acutely unwell * Children who are participants of another trial/intervention programme * Non-UK based families
Where this trial is running
Plymouth
- University of Plymouth — Plymouth, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Lisa Bunn, PhD
- Email: lisa.bunn@plymouth.ac.uk
- Phone: +44 1752 588800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.