Effectiveness in Improving Gait and Feasibility of a Transcutaneous Electrical Stimulation Garment in Children With Cerebral Palsy in Singapore
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Cadence (steps/ minute)
研究概览
简要总结
Living with cerebral palsy is challenging for the child as well as the family charged with their care and support needs. Many families seek effective and sustainable interventions to improve gait of their children with cerebral palsy. The Mollii suit is a non-invasive therapeutic technology using electrical stimulation in the form of whole-body garment with multiple electrodes individually programmed to stimulate selected muscles. This study aims to examine if the Mollii suit improve gait in ambulant children with cerebral palsy and if the Mollii suit is acceptable and tolerable to children with cerebral palsy. We will recruit up to 20 children with cerebral palsy. This study will evaluate change in gait and function following a four-week intervention period using a protocol of wearing the Mollii suit at home for one hour every day for four weeks using instrumented 3-dimensional gait analysis and objective standardised assessment tools.
详细描述
BACKGROUND
Living with cerebral palsy is challenging for the child as well as the family charged with their care and support needs. Many families seek effective and sustainable interventions to improve gait of their children with cerebral palsy. An intervention that could be used in the home setting, assessed periodically by health care professionals of a tertiary pediatric centre, that has a benefit on gait and motor function in children with cerebral palsy might be feasible to families in the local Singapore healthcare setting. The Mollii suit is a non-invasive therapeutic technology using electrical stimulation in the form of whole-body garment with multiple electrodes individually programmed to stimulate selected muscles. Based on small preliminary studies, it is suggested that the Mollii suit improves mobility, gait, function and quality of life.
OBJECTIVES
This study aims to examine the effectiveness of the Mollii suit in improving gait in children with cerebral palsy. It also aims to determine the value of the Mollii suit by evaluating the acceptability, tolerance and compliance of the Mollii suit in children with cerebral palsy.
METHODOLOGY
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 4-18
- •GMFCS level I to III
- •Spasticity as the dominant motor feature
- •Children agree to wear the Mollii suit as per procedures and consent to the study
- •Parents/carers agree to assist their child to wear the Mollii suit as per procedures
- •Medical practitioner's approval
排除标准
- •Individuals with electrical implanted stimulatory device
- •Individuals with medical devices that are affected by magnets, such as programmable shunts.
- •Individuals with cardiovascular diseases, infectious diseases, malignance (cancer), fever, pregnancy, rashes or skin problems.
- •Individuals who have had Botulinum toxin done 6 months prior intervention or soft tissue release surgery done 6 months prior intervention.
- •Individuals who have had change in oral medication for spasticity 1 month prior intervention.
结局指标
主要结局
Change in Cadence (steps/ minute)
时间窗: 2 months post intervention
The higher the cadence, the better the result.
Change in Gait Profile Score (GPS)
时间窗: 2 months post intervention
GPS is a single index measure that summarises the overall deviation of kinematic gait data relative to normative data. It ranges from 0 to 30, the higher the score, the more severe the gait. We will measure change in GPS pre and post intervention.
Change in Gait deviation index (GDI)
时间窗: 2 months post intervention
GDI provides a numerical value that expresses overall gait pathology (ranging from 0 to 100, where 100 indicates the absence of gait pathology). The higher the GDI, the better the result.
Change in Gait speed (metre/sec)
时间窗: 2 months post intervention
The faster the gait speed, the better the result.
次要结局
- Change in Functional Assessment Questionnaire (FAQ)(2 months post intervention)
- Change in ICF-CY ratings(2 months post intervention)
- Change in Gross motor function measure (GMFM)(2 months post intervention)
- Acceptance(2 months post intervention)
- Change in EQ5D(2months post intervention)
- Compliance(2 months post intervention)
研究者
Ng Zhi Min
Senior Consultant
KK Women's and Children's Hospital