Medium to Long Term Outcomes of Selective Dorsal Rhizotomy

NCT06518889 | Recruiting

• 1 other identifier: 22BI09
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy

Keywords

Selective Dorsal Rhizotomy; Rehabilitation; Physiotherapy

Outcome Measures

Primary Outcomes (4)

• Gross Motor Function Measure (GMFM)

  It is a clinical tool designed to evaluate changes in gross motor function in children with cerebral palsy. Performance-based observational tool

  Single time-point at the follow-up.

• Cerebral Palsy Quality of Life (CPQoL)

  It is a validated tool designed to assess the Quality of Life for children with cerebral palsy across a variety of domains including social wellbeing and acceptance, feelings about functioning, participation and physical health, emotional wellbeing and self-esteem, access to services, pain and impact of disability, and family and parent health.

  Single time-point; Parent and CYP questionnaire included in the online survey

• 6- Minute Walk Test

  Used to test walking capacity and endurance in children with cerebral palsy. Children use their usual walking aids, footwear and orthoses.

  Single time-point at the follow-up.

• Functional Mobility Scale (FMS)

  The FMS is a performance measure, classifying mobility on the basis of the use of mobility devices across three distances, 5m, 50m, and 500m, which represent home, school, and community distances. The mobility of the child is scored from 1 to 6 for each distance, with 1 representing use of a wheelchair and 6 representing independence on all surfaces.

  Single time-point; Parent and CYP questionnaire included in the online survey

Secondary Outcomes (7)

• Modified Ashworth Scale (MAS)

  Single time-point at the follow-up.

• Edinburgh Visual Gait Analysis Scale (EVGS)

  Single time-point at the follow-up.

• Gait Outcome Assessment List questionnaire (GOAL)

  Single time-point; CYP questionnaire included in the online survey

• Functional Assessment Questionnaire (FAQ)

  Single time-point; included in the online survey

• Selective Motor Control (SMC)

  Single time-point at the follow-up.

Interventions

Selective Dorsal Rhizotomy PROCEDURE

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.

Eligibility Criteria

• Age: 7 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children and young people with cerebral palsy who had SDR surgery at Great Ormond Street Hospital (GOSH)

You may qualify if:

• 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)

You may not qualify if:

• Children with CP classified as GMFCS level IV, V (non-ambulatory)
• Have any unrelated musculoskeletal problems, such as a recent acute injury

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead

Study Sites (1)

Great Ormond Street Hospital for Children

London, WC1N 3JH, United Kingdom

RECRUITING

Related Publications (1)

• Chugh D, Kilbride C, Gimeno H, Aquilina K, Alderson L, Theologis T, Main E. Mixed-methods study exploring medium to longer-term outcomes following selective dorsal rhizotomy in ambulatory children with cerebral palsy at a tertiary hospital in the UK: MOSAiC study protocol. BMJ Open. 2025 Dec 8;15(12):e108558. doi: 10.1136/bmjopen-2025-108558.

  PMID: 41365584 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Eleanor Main

  Great Ormond Street Institute of Child Health, University College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deepti Chugh

CONTACT

02074059200; deepti.chugh@gosh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: June 25, 2024
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

GB (1)