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临床试验/NCT07006259
NCT07006259已完成不适用

Effect of Bobath Therapy on Balance Alterations in Patients With Multiple Sclerosis

Universidad Rey Juan Carlos1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年9月26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
入组人数
45
试验地点
1
主要终点
Balance Evaluation Systems Test (Mini BESTest).

研究概览

简要总结

To evaluate the effects of a foot treatment to improve balance according to the Bobath Concept in people with Multiple sclerosis, comparing it with treatment through home exercise and with treatment from Bobath Concept combined with the use of virtual reality.

As a secondary objective, we seek to know the state of the art of Bobath therapy in Multiple Sclerosis.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • •Age: over 18 years old.
  • •Have a diagnosis of multiple sclerosis, according to Mc Donald criteria at least 6 months before the start of the intervention.
  • •Be able to walk independently in a closed environment with or without technical aids, having a maximum score of 6.5 on the Expanded Disability Status Scale or EDSS, according to its acronym in English:
  • •6.5= constant bilateral help (canes, crutches or braces) to walk about 20 meters without rest. The usual functional system (FS) is equivalent to combinations with more than two FS of grade 3+.

排除标准

  • •Participants who are not able to understand instructions,
  • •Participants who are in a clinically unstable situation or who have risk factors or concomitant pathologies of the musculoskeletal system, neurological or cardiovascular, which make it difficult to carry out the treatment.
  • •Participants with visual disturbances or severe upper limb involvement who therefore have difficulty using the VR glasses or performing reaching exercises with them.

研究组 & 干预措施

Control group

Experimental

Treatment with bobath Therapy

干预措施: Bobath Therapy (Other)

Experimental group A

Active Comparator

Bobath Therapy plus Virtual Reality

干预措施: Bobath therapy plus virtual reality (Other)

Experimental group B

Active Comparator

Home exercises

干预措施: Home exercises (Other)

结局指标

主要结局

Balance Evaluation Systems Test (Mini BESTest).

时间窗: At the beginning, at the month and we would reevaluate after 15 days

It assesses balance in six items (biomechanical restrictions, stability and verticality limits, anticipatory postural adjustments, postural responses, sensory orientation, and gait stability). It has excellent inter- and intra-observer reliability and construct validity in stroke patients. Furthermore, the items on anticipatory postural adjustments and sensory orientation are highly correlated with the risk of falls in this type of pathology.

次要结局

  • Timed Up and Go Test(At the beginning, at the month and we would reevaluate after 15 days)

研究者

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

Josue Fernandez Carnero

Principal Investigator

Universidad Rey Juan Carlos

研究点 (1)

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