NCT06518889

Medium to Long Term Outcomes of Selective Dorsal Rhizotomy

Medium to Long-term Outcomes After Selective Dorsal Rhizotomy in Ambulatory Children and Young People With Cerebral Palsy: A Mixed-methods Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 7 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to investigate the medium to long-term outcomes (3-10 years) after Selective Dorsal Rhizotomy (SDR) in ambulatory children and young people with cerebral palsy. The participants will complete a survey, come to hospital for some measurements and tests. Some parents and children and young people will also be invited to take part in an interview to understand their experiences of SDR.

Detailed description

The aim of this study is to investigate medium (3-5 years) to long-term (6-10 years) outcomes after SDR surgery in ambulatory children with CP and explore how it affects families' (CYP's and parents') lives over time. A convergent parallel mixed methods study has been designed across two work packages (WPs), which will run in parallel. The International Classification of Functioning, Disability and Health (ICF) will be used as a theoretical framework to guide the data collection and to integrate data from each WP. WP-1 is an observational cohort study and WP-2 is a qualitative study. In the observational cohort study (WP-1), routinely collected standardised outcome measures will be repeated at one additional time point, more than three years after surgery. This will mirror previous assessments carried out as part of the SDR clinical pathway, which normally concludes two years after surgery. A survey including validated Patient Reported Outcome Measures (PROMs) and a study-specific questionnaire will also be administered in WP-1. The qualitative study (WP-2) will involve an in-depth exploration of parents' and CYPs' views through semi-structured interviews to explore parents' and CYPs' experiences, reflections, and perceptions of outcomes and satisfaction of SDR in relation to previous expectations. The results from the two WPs will be combined by comparing and contrasting findings from both WPs to provide a more holistic understanding and gain deeper insights into longer-term SDR outcomes. Findings will be used to create evidence-based family resources and decision aids to help families decide whether SDR surgery is the right treatment choice for the child and support their preparation and adjustments after SDR.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
PROCEDURE	Selective Dorsal Rhizotomy	Selective Dorsal Rhizotomy (SDR) is an irreversible neurosurgical procedure where 50-70% of the sensory nerve roots are cut at the spinal level. The procedure is used to reduce lower limb spasticity permanently and is augmented by intensive rehabilitation for at least two years after surgery to optimise outcomes.

Timeline

• Start date: 2024-06-25
• Primary completion: 2025-12-01
• Completion: 2026-05-01
• First posted: 2024-07-24
• Last updated: 2024-07-24

Locations

1 site across 1 country: United Kingdom