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临床试验/NCT03424538
NCT03424538已完成不适用

The Effect of Variable Intensity Work on Postural Instability, Motion Performance and Quality of Life in Multiple Sclerosis Patients

Somogy Megyei Kaposi Mór Teaching Hospital1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2018年2月5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
2
试验地点
1
主要终点
quality of life

研究概览

简要总结

Abstract Introduction: Postural control disorders are the most common motor disorder associated with multiple sclerosis.

Objective: The aim of this study is to demonstrate the potential for improvement of postural control, motion performance and quality of life in patients with multiple sclerosis who are performing a special neurorevolutionary balancing program.

Intervention: The treated group (n = 15) performed five times a week for the treatment we defined. (60 minutes per day). The experimental group performed movements using the Xbox 360 and Kinect consoles. The study team participated in 25 sessions, five times a week. The duration of treatment was 5 weeks.The MStp group (n=14) participated in a 5-week physiotherapy course. The general treatment consisted of strengthening, stretching and walking correction. During the 5-week period, 25 patients attended training. One treatment takes 60 minutes. Sensory Organisation Test / Body Sway at the end of the baseline and treatment protocol is used to evaluate each patient. The quality of life mapping was measured by subjective tests (EQ-5D-5L, ADL). To assess the depressive state, a Beck depression questionnaire was used. Balance and motion performance were used by the Berg Balance Test and 6Minutes Walk Test. The results were compared with the control group results (n = 14) and showed improvement in overall balance and motion performance.

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 (Investigator)

入排标准

年龄范围
35 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Multiple Sclerosis
  • •instability problem

排除标准

  • •Severe heart problems, severe demeanor, alcoholism, drug problems

研究组 & 干预措施

MSt

Experimental

The MSt group that received 5 weeks of intensive therapy.

干预措施: Neurorehabilitation (Other)

MSc

No Intervention

The MS controll group that did not receive treatment.

MStp

Experimental

The MStp Group performs a traditional physiotherapy for 5 weeks.

干预措施: Physiotherapy (Other)

结局指标

主要结局

quality of life

时间窗: 5 weeks

EQ-5D (EQ-5D was first introduced in 1990 by the EuroQol Group, The EQ-5D questionnaire is made up for two components; health state description and evaluation)

balance test

时间窗: 5 weeks

Berg Balance test (The Berg Balance Scale (BBS) was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks, 41-56 = low fall risk, 21-40 = medium fall risk, 0 -20 = high fall risk )

Postural instability

时间窗: 5 weeks

Body sway (mm) (Posturography test)

mobility test

时间窗: 5 weeks

Six minutes walk test (6MWT) (m) (The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway)

次要结局

  • depression scale(5 weeks)

研究者

发起方
Somogy Megyei Kaposi Mór Teaching Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tollár József

Principal Investigator

Somogy Megyei Kaposi Mór Teaching Hospital

研究点 (1)

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