Cerebral PalsyMOSAiCNCT06518889
Medium to Long Term Outcomes of Selective Dorsal Rhizotomy
An observational study of Cerebral Palsy, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 90 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Selective Dorsal Rhizotomy
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jun 2024to May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children and young people with cerebral palsy who had SDR surgery at Great Ormond Street Hospital (GOSH)
Who may be able to join
- 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)
Who cannot join
- Children with CP classified as GMFCS level IV, V (non-ambulatory)
- Have any unrelated musculoskeletal problems, such as a recent acute injury
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Great Ormond Street Hospital for Children
London, WC1N 3JH
Deepti Chugh
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Selective Dorsal Rhizotomy
- Keywords
- Selective Dorsal Rhizotomy, Rehabilitation, Physiotherapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Dorsal RhizotomyProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Single time-point; Parent and CYP questionnaire included in the online survey
Secondary outcomes (7)
Modified Ashworth Scale (MAS)
This scale is used to measure muscle tone where a leg in moved fast passively in the available range.
Measured: Single time-point at the follow-up.
Edinburgh Visual Gait Analysis Scale (EVGS)
An observational tool to measure gait quality
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: Single time-point at the follow-up.
The Medical Research Council (MRC) Scale for Testing Muscle Strength
0 to 5 grading
Measured: Single time-point at the follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start25 Jun 2024
- Primary completionDec 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eleanor Main, Principal investigator, Great Ormond Street Institute of Child Health, University College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518889
- Sponsor's protocol ID
- 22BI09
- Acronym
- MOSAiC
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chugh D, Kilbride C, Gimeno H, Aquilina K, Alderson L, Theologis T, Main E. Mixed-methods study exploring medium to longer-term outcomes following selective dorsal rhizotomy in ambulatory children with cerebral palsy at a tertiary hospital in the UK: MOSAiC study protocol. BMJ Open. 2025 Dec 8;15(12):e108558. doi: 10.1136/bmjopen-2025-108558.
PubMed 41365584
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medium to Long-term Outcomes After Selective Dorsal Rhizotomy in Ambulatory Children and Young People With Cerebral Palsy: A Mixed-methods Study
- ClinicalTrials.gov ID
- NCT06518889
- Acronym / sponsor ID
- MOSAiC / 22BI09
- Conditions
- Cerebral Palsy
- Keywords
- Selective Dorsal Rhizotomy, Rehabilitation, Physiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children and young people with cerebral palsy who had SDR surgery at Great Ormond Street Hospital (GOSH)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Children with CP classified as GMFCS level IV, V (non-ambulatory)
- Have any unrelated musculoskeletal problems, such as a recent acute injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective Dorsal RhizotomySelective 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. | Procedure or surgery | – |
Primary outcome
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
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.
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.
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.
7 secondary outcomes
Modified Ashworth Scale (MAS)
Time frame: Single time-point at the follow-up.
Edinburgh Visual Gait Analysis Scale (EVGS)
Time frame: 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
Functional Assessment Questionnaire (FAQ)
Time frame: Single time-point; included in the online survey
Selective Motor Control (SMC)
Time frame: Single time-point at the follow-up.
Timed Up and Go (TUG)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Derived from this study: PubMed 41365584Chugh D, Kilbride C, Gimeno H, Aquilina K, Alderson L, Theologis T, Main E. Mixed-methods study exploring medium to longer-term outcomes following selective dorsal rhizotomy in ambulatory children with cerebral palsy at a tertiary hospital in the UK: MOSAiC study protocol. BMJ Open. 2025 Dec 8;15(12):e108558. doi: 10.1136/bmjopen-2025-108558.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleanor Main principal investigator
Great Ormond Street Institute of Child Health, University College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deepti Chugh (02074059200, deepti.chugh@gosh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Measure (GMFM) (time frame: Single time-point at the follow-up.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06518889, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.