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临床试验/NCT01621984
NCT01621984已完成1 期

The Evaluation of Therapeutic Riding in Children and Adolescent With Kinetic Deficits Because of Neuromuscular Disease.

University of Ioannina1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年6月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Change from baseline in posture control at different time points

研究概览

简要总结

The purpose of this current prospective study is to assess the effects of a Therapeutic Riding exercise program conducted in patients suffering from neuromuscular disease. The exercise intervention aims at improving gross motor function, gross motor performance, balance, spasticity, posture and quality of life. Patients were randomized according to age, sex, mental ability and gross motor function. Furthermore, patients will be subdivided into categories of central nervous system (brain/ spinal cord) and peripheral (peripheral nerve or muscle) diseases. The exercise program duration will be 12 weeks, once a week with 30-40 minutes sessions. Six measurements will be conducted: the Gross Motor Function Measure, the Gross Motor Performance Measure, the Quality of life Questionnaire for Children, the Pediatric Balance Scale, the dynamic plate in combination with x-ray for posture control, the Modified Ashworth Scale for spasticity and the Wisc 3 for mental ability. The results will be collected and evaluated using the statistical programme SPSS.

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
Single (Outcomes Assessor)

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

入选标准

  • Children with neuromuscular disease
  • Parental consent
  • Sitting posture capability
  • Hip abduction capability on horseback
  • Ability to communicate and collaborate with the researcher

排除标准

  • Children with Scheuermann disease
  • uncontrolled seizures (A) child with generalized seizure over 2 minutes in the last three months (B) Children who are not well-adjusted levels of antiepileptic drugs.
  • musculoskeletal disorder that may be aggravated by the movement of the horse such as atlantoaxial instability, osteoporosis etc.
  • Scoliosis > 30 degree
  • Allergy to dust

研究组 & 干预措施

Therapeutic Riding/ Hippotherapy

Experimental

12 week Therapeutic Riding program that focused on gross motor function, gross motor performance, balance, spasticity, posture and quality of life

干预措施: Therapeutic Riding/ Hippotherapy Intervention (Other)

without Therapeutic Riding/ Hippotherapy

No Intervention

结局指标

主要结局

Change from baseline in posture control at different time points

时间窗: Measures will be done: 1 two months before treatment, 2 one month before treatment, 3 one day before start of treatment, 4 six weeks after the start of treatment, 5 twelve weeks, the end of treatment 6 two months after the end of treatment.

posture control measured by the dynamic plate in combination with x-ray.

Change from baseline in balance at different time points

时间窗: Measures will be done: 1 two months before treatment, 2 one month before treatment, 3 one day before start of treatment, 4 six weeks after the start of treatment, 5 twelve weeks, the end of treatment 6 two months after the end of treatment.

Balance measured by the Pediatric Balance Scale

次要结局

  • Improvement in Gross Motor Function(Measures will be done: 1 two months before treatment, 2 one month before treatment, 3 just before treatment, 4 six weeks after the start of treatment, 5 twelve weeks, the end of treatment 6 two months after the end of treatment.)
  • Improvement in Quality of life(Measures will be done: 1 two months before treatment, 2 one month before treatment, 3 just before treatment, 4 six weeks after the start of treatment, 5 twelve weeks, the end of treatment 6 two months after the end of treatment.)
  • Improvement in Gross Motor Performance(Measures will be done: 1 two months before treatment, 2 one month before treatment, 3 just before treatment, 4 six weeks after the start of treatment, 5 twelve weeks, the end of treatment 6 two months after the end of treatment.)
  • Decrease of spasticity(Measures will be done: 1 two months before treatment, 2 one month before treatment, 3 just before treatment, 4 six weeks after the start of treatment, 5 twelve weeks, the end of treatment 6 two months after the end of treatment.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Avraam Ploumis

Assistant Professor of PMR, Orthopaedic Spine Surgeon

University of Ioannina

研究点 (1)

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