Medium to Long Term Outcomes of Selective Dorsal Rhizotomy
ConditionCerebral Palsy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-90
SponsorGreat Ormond Street Hospital for Children NHS Foundation Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Children with CP classified as GMFCS level IV, V (non-ambulatory)
Have any unrelated musculoskeletal problems, such as a recent acute injury
Trial population
Children and young people with cerebral palsy who had SDR surgery at Great Ormond Street Hospital (GOSH)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Selective Dorsal Rhizotomy
Procedure/SurgerySelective 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
Single time-point at the follow-up.2
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.
Time frame
Single time-point; Parent and CYP questionnaire included in the online survey3
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.
Time frame
Single time-point at the follow-up.4
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.
Time frame
Single time-point; Parent and CYP questionnaire included in the online surveySecondary outcomes
1
Modified Ashworth Scale (MAS)
This scale is used to measure muscle tone where a leg in moved fast passively in the available range.
Time frame
Single time-point at the follow-up.2
Edinburgh Visual Gait Analysis Scale (EVGS)
An observational tool to measure gait quality
Time frame
Single time-point at the follow-up.3
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.
Time frame
Single time-point; CYP questionnaire included in the online survey4
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.
Time frame
Single time-point; included in the online surveySponsors and contacts
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Source ClinicalTrials.gov