Medium to Long-term Outcomes After Selective Dorsal Rhizotomy in Ambulatory Children and Young People With Cerebral Palsy: A Mixed-methods Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Cerebral Palsy Quality of Life (CPQoL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Children with CP classified as GMFCS level IV, V (non-ambulatory)
- •Have any unrelated musculoskeletal problems, such as a recent acute injury
结局指标
主要结局
Cerebral Palsy Quality of Life (CPQoL)
时间窗: 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.
Functional Mobility Scale (FMS)
时间窗: 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.
Gross Motor Function Measure (GMFM)
时间窗: 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
6- Minute Walk Test
时间窗: 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.
次要结局
- Modified Ashworth Scale (MAS)(Single time-point at the follow-up.)
- Selective Motor Control (SMC)(Single time-point at the follow-up.)
- Edinburgh Visual Gait Analysis Scale (EVGS)(Single time-point at the follow-up.)
- The Medical Research Council (MRC) Scale for Testing Muscle Strength(Single time-point at the follow-up.)
- Gait Outcome Assessment List questionnaire (GOAL)(Single time-point; CYP questionnaire included in the online survey)
- Timed Up and Go (TUG)(Single time-point at the follow-up.)
- Functional Assessment Questionnaire (FAQ)(Single time-point; included in the online survey)