Effect of Hydrotherapy (Halliwick Concept)on Motor Function in Spastic Cerebral Palsy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from Gross motor function measure at 3 months [ Time Frame: 3 months ]
研究概览
简要总结
This randomized controlled trial will investigate the effect of hydrotherapy (halliwick concept) on motor functions in children with spastic cerebral palsy (CP). Minimum of 30 Spastic CP children will be recruited for this study. Children will be randomly assigned into control group who will receive conventional selected exercise treatment or study group who will receive the same conventional program in addition to underwater exercise program. Motor function will be evaluated at baseline and after 3 months of treatment. No potential harms are expected during this study.
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
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from both sexes diagnosed with spastic CP according to a pediatrician
- •The degree of spasticity will be determined as grade two or less according to modified Ashworth scale
- •Their age will range from five to nine years
- •Intelligence quotient score > 35 (no worse than moderate intellectual disability) as assessed via Wechsler test scales
- •No severe psychosocial or behavioral problems, such high aggression or risk of self-harm.
排除标准
- •Initiation of oral antispastic medication
- •botulinum toxin injections or surgery performed less than 90 days before enrollment
- •severe visual or auditory impairment
- •uncontrollable epilepsy (defined as the occurrence of seizures despite the use of at least one antiepileptic drug)
- •open wounds
- •children with a psychiatric disorder
- •cognitive disorders evaluated by the pediatric evaluation of disability inventory
- •uncontrolled epilepsy
- •active infection
- •severe cardiopulmonary disorders.
研究组 & 干预措施
Group A (Halliwick method group)
Under water exercise program according to halliwick concept which will be applied as three sessions per week for three successive months. Underwater exercises will be performed under the supervision of a certified aquatic therapist. This practitioner will instruct the child in proper techniques for performing exercises while ensuring child's safety by using flotation devices, body boards or float belts when necessary. Also the pool where the children will perform underwater exercises will be equipped with ramps, chair lifts, stairs, and handrails to facilitate a child's ability to access the pool.
干预措施: Aquatic Halliwick method (Other)
Group B (conventional physical therapy group)
Conventional selected exercise program for 60 minutes , three sessions per week for three successive months aiming to improve the motor functions of the children in form of: (1) Neuro-developmental technique, (2) Back and abdominal exercises, (3) improving postural responses, (4) Flexibility exercises, (5) Strengthening exercise (particularly knee extensors, hip abductors and the ankle dorsi-flexors muscles) and (6) Improving standing, weight transfer and shift and finally facilitation of normal walking pattern .
干预措施: Conventional physical therapy (Procedure)
结局指标
主要结局
Change from Gross motor function measure at 3 months [ Time Frame: 3 months ]
时间窗: Baseline and after 3 months
The Gross Motor Function Measure (GMFM) is an observational clinical tool designed to evaluate change in gross motor function in children with cerebral palsy. There are two versions of the GMFM - the original 88-item measure (GMFM-88) and the more recent 66-item GMFM (GMFM-66) The scoring system of the GMFM is a four-point scale divided into five categories (lying and rolling; sitting; crawling and kneeling; standing; walking, running).
次要结局
未报告次要终点
研究者
Mohamed Magdy Ali Hassan ElMeligie
Principal investigator
October 6 University