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临床试验/NCT03887507
NCT03887507已完成不适用

The Implementation of a Reflex Locomotion Program According to Vojta Produces Short-term Automatic Postural Control Changes in Patients With Multiple Sclerosis.

NUMEN Foundation2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2019年1月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
2
主要终点
10 metres walk

研究概览

简要总结

This Study evaluates the effectiveness of a Vojta locomotion reflex program as short-term automatic postural control in patients with Multiple sclerosis

详细描述

In two consecutive weeks two interventions will be conducted: Vojta group(A) and standard therapy group(B). The last one is based on balance exercises targeting core stability, Bobath concept and sensory strategies. In the Vojta group 5 sessions will be conducted for a duration of 2 weeks and the same will be realised on the standard group. In addition, during the study, a daily activity shall be prescribed in both groups: Vojta exercise during 20 minutes for group A and walking for 20 minutes in group B.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Final diagnosis of MS according to McDonald criteria.
  • Walkability with or without assistance (4.0 to 6.5 in EDSS) and dysfunctions defined by the inability to hold the tandem position for 30 seconds with the arms close to body.
  • Older than 18 years-old.
  • Escorted sessions, a family member or close person.

排除标准

  • Phase outbreak or outbreak in the 3 months before the study.
  • Medication that prevents or limits the performance of the Locomotion reflex.
  • Participation in other studies during the conduct of this study.
  • Score inferior to 6 in the Abbreviated Mental Test that prevents understanding of the study consent or that limits the understanding of the test during its realisation.

研究组 & 干预措施

Experimental

Experimental

There will be 3 Vojta therapy sessions conducted on 2 consecutive weeks with an interval of 7 dayssessions, on 1st, 7th and 14th days. Each session will consist of a 45-minute Vojta thera between py protocol based on three exercises, 15 minutes per exercise: Crawling Réflex, and 1st phase and 2nd phase Rolling reflex. The relative or close person will be instructed to carry out an exercise protocol to do at home every day for 20 minutes during the 2-week study. All interventions will be made by the principal investigator.

干预措施: Vojta Therapy (Other)

Standard Therapy

Active Comparator

The standard group shall perform 4 sessions of physiotherapy in the same period for two consecutive weeks, with one hour per session in its specialized MS association, on 1st, 3rd, 8th, 10th and 15th days. This will be applied by experienced physiotherapists during the treatment of people with MS. The program will consist in balance exercises targeting core stability, exercises of coordination and Pilates as well as individual sessions using the Bobath concept. Patients in this group will walk at least for 20 minutes per day during the study period.

干预措施: Standard Program (Other)

结局指标

主要结局

10 metres walk

时间窗: 2 weeks

This Test measures the speed during 10 meter walking at normal pace

Berg Balance Scale

时间窗: 2 weeks

This test measures the automatic postural control. The Berg scale comprises 14 items (score included 0-4). The total scores can range from 0 (severely affected balance) to 56 (excellent balance).

次要结局

  • Tandem 6 metres test(2 weeks)

研究者

发起方
NUMEN Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luis Perales Lopez

Physiotherapy service coordinator

NUMEN Foundation

研究点 (2)

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