Clinical Effectiveness of Increased Standing Time in Non-ambulant Children With Cerebral Palsy:a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Hip migration Percentage
研究概览
简要总结
Children with cerebral palsy commonly use standing frames to position them to help prevent contracture and deformity and to help their function. There is a lack of evidence to support the correct dosage of standing frame use.
The aim of this study is to pilot a randomised controlled trial of the clinical effects of doubling the duration of standing, using standing frames, in young children who are unable to walk, who have cerebral palsy or developmental delay.
It will determine whether it is feasable to carry out a multi-centred trial.
The study objectives will be to determine:
- presence of adverse events
- recruitment and drop out rate
- compliance with the intervention
- feasibility of the randomisation and minimisation process
- the proportion of the outcome measures taken
- effect size estimate
- required study costs
- effectiveness of blinding procedure
详细描述
Thirty non-ambulant children with cerebral palsy will be randomised into one of two groups that either (a) maintains the child's current standing frame program- the control group (n=15) (b) doubles the standing time- the intervention group (n=15). Outcome measures will be taken at baseline and at 6 monthly intervals by a blinded assessor.
Research process and flow Families who are willing to participate in the study will be provided with a diary sheet that will allow them to record over a baseline 2 week period how frequently their child stood and in what position. The diary sheet will be available in word or hard copy format. An e mail/ stamped addressed envelope will be provided to return the diary at the end of 2 weeks. Participants will be reminded via text/ phone / e mail (depending on their preferred method of communication) after 1 week if they have not returned their diary sheets.
On receipt of the diary sheets participants will be randomized into an intervention or control group (see below). A therapist will explain the group allocation to the families at their home or their local CDC. The trial will run for 12 months with the outcome measures being taken by an assessor blinded to group allocation. The primary outcome measure (hip migration percentage) will be taken at 0 and 12 months so as to fit in with practice across the South West and not to increase x ray exposure. The secondary outcome measures will be taken at baseline, 6 and 12 months. The final RCT will involve a 3 yr follow-up phase.
Sample Size We aim to recruit 15 people per group. An audit of CDC records suggests that there are between 5-6 eligible participants over a 12 month recruitment period. With 8 main recruitment centres this would result in 40-48 potential participants and a required recruitment rate of 75-63%. An on-going study looking at walking in children with older children with CP at Plymouth University suggests that this recruitment rate is feasible. Determining the actual recruitment rate in this particular patient population and the feasibility of using multiple centres across one region is one objective of the pilot study.
Randomisation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of cerebral palsy or developmental delay
- •Aged between 1-12 years at the beginning of the study
- •Signs UMN involvement with spasticity or hypertonia in at least one limb
- •Gross motor function classification III-V
- •undertaking a standing programme of at least 1.5hours per week for at least a month
排除标准
- •Soft tissue release that would require imobilization which would prevent standing within 6 months from the onset of the trial
- •Bony surgery Soft that would require imobilization which would prevent standing within 12 months from the onset of the trial
- •a fracture that would prevent standing
研究组 & 干预措施
Control
Normal standing time
干预措施: control (Behavioral)
Doubling standing time
Doubled standing time calculated by doubling baseline standing time
干预措施: Doubling standing time (Behavioral)
结局指标
主要结局
Hip migration Percentage
时间窗: baseline and 12 months
In line with planned hip screening, not additional x rays.
次要结局
- Muscle length(0, 6 months and 12 months)
- Paediatric pain profile(0, 6 12 months)
- Standing time(weekly over 12 months)
- CP CHILD questionnaire(0, 6, 12 months)
- Rectus femoris circumference using ultrasound(0, 6, 12 months)
- Muscle tone hip flexors hamstrings and ankle plantarflexors Tardieu test(0, 6, 12 months)
- Muscle tone of gastrocnemius using the myotonometer(0, 6, 12 months)
- Gross motor function measure(0, 6, 12 months)
研究者
Rachel Rapson
Research Assistant
University of Plymouth