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临床试验/NCT03193489
NCT03193489已完成不适用

A High-intensity Multi-component Agility Intervention in Parkinson's Patients: Two-year Follow-up

Somogy Megyei Kaposi Mór Teaching Hospital0 个研究点目标入组 3 人开始时间: 2015年5月11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
3
主要终点
EQ5D-5L

研究概览

简要总结

Individualization of exercise is recommended but rarely performed in patients with Parkinson's disease (PD).

Unusually High Intensity and Individual Sensor Motor with Visuomotor Mobility Trainer The clinical symptoms, mobility and posture of PD patients. After 3 weeks of intensive treatment, treated patients and the control group were subjected to a two-year observation.

Objectives: The effect of the unusually highly intense and strictly individualized sensomotor and visuomotor agility program was determined for the clinical symptoms, mobility and stability of non-demented PD patients with a two-year follow-up. Detection and comparison of results of patients undergoing biphasic maintenance with the results of intensively treated patients and the control group.

Patients were recalled every 3 months after the first intensive examination and one year after a one-year control. The results of the active group were continuously compared with the results of the passive and control groups, thus determining the effectiveness of our treatment and the deterioration of the other groups in life-quality.

The treated groups will be divided into two. One Parkinson's group takes part in a treadmill treatment that takes place 3 times a week for 2 years. The other group does not undergo a special series of exercises after 3 weeks of intensive therapy.

Main outcome measures: Movement disorder Society Unified Parkinson Disease Rating Scale, Motor Experiences of Daily Living, a measure sensitive to changes in a broad spectrum of PD symptoms.

In group time, repeated measurements of variance analysis were compared to MDS-UPDRS M-EDL, Beck Depression Score, PDQ-39, EQ5D VAS, Schwab & England Scale for Parkinson's Disease. The TUG test and 12 static posturographic measurements are compared and compared to the healthy group as a standard.

An at-limit and individualized sensorimotor and visuomotor agility exercise program vs. standard care, will improve non-demeted, stage 2-3 PD patient's clinical symptoms, mobility, and postural stability by functionally meaningful margins. As a long-term solution, a follow-up treatment can slow down the progression of clinical symtoms.

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
None

入排标准

年龄范围
55 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Parkinson's disease
  • •Hoenh Yahr scale of 2-3
  • •Instability problem

排除标准

  • •Severe heart problems
  • •Severe demeanor
  • •Alcoholism
  • •Drug problems

研究组 & 干预措施

Exercise therapy

Experimental

Parkinson's group takes part in a treadmill treatment that takes place 3 times a week for 2 years.

干预措施: Follow-up (Other)

Exercise therapy

Experimental

Parkinson's group takes part in a treadmill treatment that takes place 3 times a week for 2 years.

干预措施: Post-treatment control (Other)

Exercise therapy

Experimental

Parkinson's group takes part in a treadmill treatment that takes place 3 times a week for 2 years.

干预措施: Control Parkinson group (Other)

结局指标

主要结局

EQ5D-5L

时间窗: 0-5 scale (2 year-long, higher point is better)

Questionnaire

posturography

时间窗: mm (2 year-long, the smaller the mm the better the result)

body sway, Objective measurement of holding instability

Timed up and Go test

时间窗: sec (2 year-long, the less time you take the test, the better the result )

Measuring the speed of walking

次要结局

未报告次要终点

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

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