Medium to Long Term Outcomes of Selective Dorsal Rhizotomy (MOSAiC)

July 18, 2024 updated by: Great Ormond Street Hospital for Children NHS Foundation Trust

Medium to Long-term Outcomes After Selective Dorsal Rhizotomy in Ambulatory Children and Young People With Cerebral Palsy: A Mixed-methods Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1N 3JH
        • Recruiting
        • Great Ormond Street Hospital for Children
        • Contact:
          • Deepti Chugh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children and young people with cerebral palsy who had SDR surgery at Great Ormond Street Hospital (GOSH)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross Motor Function Measure (GMFM)
Time Frame: Single time-point at the follow-up.
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)
Time Frame: Single time-point; Parent and CYP questionnaire included in the online survey
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
Time Frame: Single time-point at the follow-up.
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)
Time Frame: Single time-point; Parent and CYP questionnaire included in the online survey
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

Outcome Measure
Measure Description
Time Frame
Modified Ashworth Scale (MAS)
Time Frame: Single time-point at the follow-up.
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)
Time Frame: Single time-point at the follow-up.
An observational tool to measure gait quality
Single time-point at the follow-up.
Gait Outcome Assessment List questionnaire (GOAL)
Time Frame: Single time-point; CYP questionnaire included in the online survey

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)
Time Frame: Single time-point; included in the online survey
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)
Time Frame: Single time-point at the follow-up.
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)
Time Frame: Single time-point at the follow-up.
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
Time Frame: Single time-point at the follow-up.
0 to 5 grading
Single time-point at the follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Investigators

  • Principal Investigator: Eleanor Main, Great Ormond Street Institute of Child Health, University College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

July 18, 2024

First Submitted That Met QC Criteria

July 18, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Actual)

July 24, 2024

Last Update Submitted That Met QC Criteria

July 18, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22BI09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe