Medium to Long Term Outcomes of Selective Dorsal Rhizotomy
NCT ID: NCT06518889
Last Updated: 2024-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
90 participants
OBSERVATIONAL
2024-06-25
2026-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Selective Dorsal Rhizotomy
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
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Inclusion Criteria
* 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
* Have any unrelated musculoskeletal problems, such as a recent acute injury
7 Years
90 Years
ALL
No
Sponsors
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Great Ormond Street Hospital for Children NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Eleanor Main
Role: PRINCIPAL_INVESTIGATOR
Great Ormond Street Institute of Child Health, University College London
Locations
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Great Ormond Street Hospital for Children
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Deepti Chugh
Role: primary
Other Identifiers
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22BI09
Identifier Type: -
Identifier Source: org_study_id
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