Medium to Long Term Outcomes of Selective Dorsal Rhizotomy
NCT Number: NCT06518889
Acronym: MOSAiC
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cerebral Palsy
Interventions: PROCEDURE: Selective Dorsal Rhizotomy
Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-25
Completion Date: 2026-05
Locations: Great Ormond Street Hospital for Children, London, WC1N 3JH, United Kingdom

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.

Primary Outcome Measures: 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 Outcome Measures: Modified Ashworth Scale (MAS), This scale is used to measure muscle tone where a leg in moved fast passively in the available range., Single time-point at the follow-up.|Edinburgh Visual Gait Analysis Scale (EVGS), An observational tool to measure gait quality, Single time-point at the follow-up.|Gait Outcome Assessment List questionnaire (GOAL), The Gait Outcomes Assessment List (GOAL) questionnaire is used to evaluate gait priorities and functional mobility for ambulant children with CP. Scores are additive to provide the item score. Scores for each domain and for the total GOAL are standardized and range from 0 (worst) to 100(best).

Standardized item, domain, and total GOAL scores are calculated for each child. The maximum total GOAL score is 100 and a higher GOAL score equates to higher function., Single time-point; CYP questionnaire included in the online survey|Functional Assessment Questionnaire (FAQ), The FAQ is a 10-point scale of the typical level of a child's walking function in their community environment. The walking scale is scored from 1 'cannot take any steps at all' to 10'walks, runs and climbs on level and uneven terrain without difficulty or assistance'. The FAQ is a measure of performance., Single time-point; included in the online survey|Selective Motor Control (SMC), Grading of selective ankle dorsiflexion movement at the ankle ( 0 to 4 scale), Single time-point at the follow-up.|Timed Up and Go (TUG), A functional dynamic balance test. The time taken for the child to stand up from a chair, walk 3 m, turn around, walk back, and sit down is recorded., Single time-point at the follow-up.|The Medical Research Council (MRC) Scale for Testing Muscle Strength, 0 to 5 grading, Single time-point at the follow-up.