Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518889
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Medium to Long Term Outcomes of Selective Dorsal Rhizotomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Medium to Long-term Outcomes After Selective Dorsal Rhizotomy in Ambulatory Children and Young People With Cerebral Palsy A Mixed-methods Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOSAiC
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
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 CYPs 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None