An observational study in Cerebral Palsy, sponsored by Great Ormond Street Hospital for Children NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 7 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-07-24.
Sponsored by Great Ormond Street Hospital for Children NHS Foundation Trust · Observational
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.
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.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's planned enrollment of 90 is above the median of 63 across 472 observational studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Great Ormond Street Hospital for Children NHS Foundation Trust is the lead sponsor of 82 studies on the registry; 19 are open to participants now.
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Children and young people with cerebral palsy who had SDR surgery at Great Ormond Street Hospital (GOSH)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Parents of CYP with CP who have undergone SDR surgery (and meet the above criteria for CYP)
Exclusion Criteria:
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.
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.
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 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.
Time frame: 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.
Time frame: Single time-point; Parent and CYP questionnaire included in the online survey
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.
Edinburgh Visual Gait Analysis Scale (EVGS)
An observational tool to measure gait quality
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: Single time-point at the follow-up.
The Medical Research Council (MRC) Scale for Testing Muscle Strength
0 to 5 grading
Time frame: Single time-point at the follow-up.
Plan to share: Undecided
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Great Ormond Street Hospital for Children NHS Foundation Trust