Commissioning Through Evaluation: Selective Dorsal Rhizotomy Database
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 主要终点
- Change in the Cerebral Palsy Quality of Life Questionnaire for Children
研究概览
简要总结
A national database is being set-up to collate clinical outcome information before and after children undergo Selective Dorsal Rhizotomy (SDR). SDR is a surgical procedure that has been used for many years but has not been routinely available within the United Kingdom National Health Service (NHS). The SDR procedure is used to improve spasticity in children with cerebral palsy and involves dividing some of the nerve fibres running from the muscles back to the spinal cord. While it is believed that SDR is effective, there are no definitive data. In July 2014 NHS England commissioned five NHS Trusts to undertake SDR surgery in eligible children for a two-year period, and to collect detailed information on their outcomes. The proposed database will aggregate these data from the five centres and analyse them to provide overall evidence on the clinical effectiveness of SDR. This information will be used to inform future commissioning decisions. The database has been developed by the King's Technology Evaluation Centre (KiTEC) in conjunction with NHS England and the national clinical SDR steering committee and its data subcommittee. KiTEC undertakes research evaluations for the National Institute for Health and Care Excellence (NICE), and has been commissioned by NICE to undertake this work. Clinicians in the SDR data subgroup have liaised closely with KiTEC to agree which data to collect so that it the least amount needed and will be in a standardised format across all centres. When all two-year outcome data are recorded, KiTEC will analyse the data and present a report to NHS England, NICE and the SDR steering committee and data sub-group. While there are no firm plans to follow the children beyond two years post-surgery, all parties involved are hoping that further funding can be obtained to continue following these children up as these data will be unique.
详细描述
Disease overview:
Cerebral Palsy is an all-encompassing term for numerous neurological conditions caused by problems in the brain and nervous system. More specifically, cerebral palsy is related to problems in muscle movement, which result in abnormalities in walking, posture, and balance. Other important functions can also be affected, such as language/communication, learning, and vision. There is currently no cure for cerebral palsy; however, there are several treatment options that can aid alleviation of symptoms and improve quality of life. The selection of appropriate treatment(s) for each child requires input from a multi-disciplinary team of health professionals, such as paediatricians, social workers, physiotherapists, speech and language therapists, occupational therapists, neurologists and surgeons.
Treatment overview:
The National Institute for Health and Care Excellence (NICE) published guidance related to treatment options for cerebral palsy in 2012 (CG145). One of the treatment options discussed was Selective Dorsal Rhizotomy (SDR). SDR is an irreversible surgical procedure, which involves the division of some of the sensory nerves of the spinal cord in order to reduce sensory input to the sensory-motor reflex arcs. Intensive physiotherapy is required SDR post surgery for up to 24 months to achieve the outcome goals of improvement in muscle function, tone, and quality of life. NICE CG145 recommends consideration of SDR in children with a GMFCS level II or III. This recommendation was based on a review of evidence evaluation, which concluded that there was reasonable evidence that SDR combined with appropriate post-operative treatment can result in significant improvements in motor function and quality of life.
Study Overview:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who have consented to the SDR procedure in one of the five Trusts who are commissioned to do SDR.
- •These will be asked to consent to their outcome data being added to the national database. There are no exclusions to the database.
- •For inclusion in the CTE SDR programme, the criteria were established as:
- •Children between the ages of 3 and 9 years with a diagnosis of spastic diplegic cerebral palsy (based on NICE guidance [2]).
- •Dynamic spasticity in lower limbs affecting function and mobility and no dystonia
- •MRI shows typical Cerebral palsy changes and no damage to key areas of brain controlling posture and coordination.
- •GMFCS level II or III.
- •No evidence of genetic or neurological progressive illness.
- •Mild to moderate lower limb weakness with ability to maintain antigravity postures.
- •No significant scoliosis or hip dislocation (Reimer's index [10] should be <40%).
- •In addition to the above clinical criteria there must be written agreement from the referring responsible commissioner confirming financial and resource commitment to provide the post operative physiotherapy package as outlined in the CTE SDR programme selection criteria [5].
排除标准
- •Under 3 years of age, or older than 9 years.
- •Gross Motor Function Classification System levels I, IV or V.
- •Any other medical or personal aspects in conflict with those listed above under inclusion criteria.
结局指标
主要结局
Change in the Cerebral Palsy Quality of Life Questionnaire for Children
时间窗: Change from Baseline, to 6 months, 12 months and 24 months
The Change in the Cerebral Palsy Quality of Life Questionnaire for Children, is a quality of life measure for children with cerebral palsy which can be completed by either the child, or the parent. It contains 53 items in the child version, and 65 items in the parent version.
Change in Gross Motor Function Measure (GMFM-66)
时间窗: Change from baseline, to 6 months, 12 months and 24 months.
The GMFM-66 is a clinical tool to evaluate gross mortar function change in children with cerebral palsy. It contains 66 items in the tool, which a aggregated using a predefined summary calculation of all completed items.
次要结局
- Duncan Ely Test: used to assess rectus femoris spasticity or tightness(Change from Baseline, to 6 months, 12 months and 24 months)
- Modified Ashworth Scale(Change from Baseline, to 6 months, 12 months and 24 months)
- Physiotherapy assessment measures: use of mobility and orthotic devices, and functional mobility scale.(Change from Baseline, to 6 months, 12 months and 24 months)