Long-term outcomes of Selective Dorsal Rhizotomy in children with cerebral palsy
Medium to Long-term Outcomes After Selective Dorsal Rhizotomy in Ambulatory Children and Young People With Cerebral Palsy: A Mixed-methods Study
This study looks at how well Selective Dorsal Rhizotomy helps children with cerebral palsy over several years by gathering their feedback and measuring their progress.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 7 Years to 90 Years |
| Sex | All |
| Sponsor | Great Ormond Street Hospital for Children NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06518889 on ClinicalTrials.gov |
What this trial studies
This study investigates the medium to long-term outcomes of Selective Dorsal Rhizotomy (SDR) in ambulatory children and young people with cerebral palsy over a period of 3 to 10 years. Participants will complete surveys and undergo measurements and tests at the hospital, while some will also participate in interviews to share their experiences. The study employs a mixed methods approach, combining quantitative data from standardized outcome measures with qualitative insights from interviews to provide a comprehensive understanding of the impact of SDR on patients and their families. The International Classification of Functioning, Disability and Health (ICF) framework guides the data collection and integration.
Who should consider this trial
Good fit: Ideal candidates include children and young people aged 2-15 years with cerebral palsy classified as GMFCS level II and III who have undergone SDR surgery at Great Ormond Street Hospital.
Not a fit: Patients classified as GMFCS level IV or V (non-ambulatory) or those with unrelated musculoskeletal problems may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness of SDR, potentially improving treatment approaches for children with cerebral palsy.
How similar studies have performed: While there have been studies on SDR, this particular approach focusing on long-term outcomes and mixed methods is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children and young people with cerebral palsy (CYPwCP) * Classified as GMFCS level II and III (ambulatory) * Aged between 2-15 years at the time of surgery * Underwent SDR surgery at Great Ormond Street Hospital for Children (GOSH) (between 2013- 2021) * Had baseline (pre-surgery) assessment and at least one follow-up assessment at 6, 12 or 24 months post-SDR Parents of CYP with CP who have undergone SDR surgery (and meet the above criteria for CYP) Exclusion Criteria: * Children with CP classified as GMFCS level IV, V (non-ambulatory) * Have any unrelated musculoskeletal problems, such as a recent acute injury
Where this trial is running
London
- Great Ormond Street Hospital for Children — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Eleanor Main — Great Ormond Street Institute of Child Health, University College London
- Study coordinator: Deepti Chugh
- Email: deepti.chugh@gosh.nhs.uk
- Phone: 02074059200
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.