Clinical trial NCT06518889: Medium to Long Term Outcomes of Selective Dorsal Rhizotomy
Official title: Medium to Long-term Outcomes After Selective Dorsal Rhizotomy in Ambulatory Children and Young People With Cerebral Palsy: A Mixed-methods Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy
Keywords: Selective Dorsal Rhizotomy
Rehabilitation
Physiotherapy
Lead sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 90
Sex: ALL
Minimum age (years): 7
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and young people with cerebral palsy who had SDR surgery at Great Ormond Street Hospital (GOSH)

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: Gross Motor Function Measure (GMFM)
timeFrame: Single time-point at the follow-up.
measure: Cerebral Palsy Quality of Life (CPQoL)
timeFrame: Single time-point; Parent and CYP questionnaire included in the online survey
measure: 6- Minute Walk Test
timeFrame: Single time-point at the follow-up.
measure: Functional Mobility Scale (FMS)
timeFrame: Single time-point; Parent and CYP questionnaire included in the online survey
Secondary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: Single time-point at the follow-up.
measure: Edinburgh Visual Gait Analysis Scale (EVGS)
timeFrame: Single time-point at the follow-up.
measure: Gait Outcome Assessment List questionnaire (GOAL)
timeFrame: Single time-point; CYP questionnaire included in the online survey
measure: Functional Assessment Questionnaire (FAQ)
timeFrame: Single time-point; included in the online survey
measure: Selective Motor Control (SMC)
timeFrame: Single time-point at the follow-up.
measure: Timed Up and Go (TUG)
timeFrame: Single time-point at the follow-up.
measure: The Medical Research Council (MRC) Scale for Testing Muscle Strength
timeFrame: Single time-point at the follow-up.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children
Study officials:
affiliation: Great Ormond Street Institute of Child Health, University College London
name: Eleanor Main
role: PRINCIPAL_INVESTIGATOR
References: