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临床试验/NCT01076712
NCT01076712Unknown不适用

The Effectiveness of Physiotherapy Interventions in Patients With Parkinson's Disease, a Randomized Controlled Trial

Queen Elizabeth Hospital, Hong Kong1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2010年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
112
试验地点
1
主要终点
Movement Disorder Society-Unified Parkinson's Disease Rating Scale

研究概览

简要总结

Parkinson's Disease is an incurable and progressive disease. Treatment includes medication and non-pharmacological intervention such as physiotherapy. Physiotherapy is a main component of non-pharmacological interventions. It includes exercise to strengthen the muscles; improves balance and walking, and adopts the use of visual cue training. Treatment has been found to be effective in patients with mild impairment up to 6 months post-treatment. The present study will investigate the effectiveness of treatment for patients with mild to moderate impairment for short term (3-month) and long term (1 year). The hypothesis is that compared to patient education alone, physiotherapy intervention for patients with Parkinson's disease leads to improve function and quality of life.

详细描述

Parkinson's disease (PD) is an incurable and progressive disease (Rubenis 2007). Current management include medical, neuro-surgical and non-pharmacological intervention. Physiotherapy is a major component in non-pharmacological interventions. Effective interventions including visual or auditory cues improves gait (Nieuwboer et al. 2007), exercise is effective in improving balance (Hirsch et al 2003); intense treadmill training improves motor control, quality of life and walking speed so as to sustain improvement in gait speed and motor control post 4 weeks of treatment (Herman et al 2007). Patient with PD attending physiotherapy twice weekly, one and half hour for 12 weeks showed improvement in walking speed and Activities of Daily Living (Ellis et al 2005). However, the majority of focus on patients in the Hoehn and Yahr stage of 2 to 3 and long term effect is lacking (Kwakkel et al 2007). A knowledge gap is present in the effectiveness of physiotherapy training of patients with Parkinson's disease in the more advanced stage of disease and long term effect is lacking. The aim of the study is to investigate the immediate, short-term & long-term clinical effects of physiotherapy training of patients with Parkinson's disease. The hypothesis is that compared to patient education alone, physiotherapy intervention for patients with Parkinson's disease leads to improve function and quality of life.

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 (Outcomes Assessor)

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stable medication usage
  • Hoehn and Yahr stage II to IV
  • At least 1 score of 2 or more for at least 1 limb of either the tremor, rigidity, or bradykinesia item of the Unified Parkinson's Disease Rating Scale (UPDRS)
  • Able to walk independently
  • No severe cognitive impairments (Mini-Mental State Examination - Chinese Cantonese version) score greater than 24

排除标准

  • Other severe neurological, cardiopulmonary, or orthopedic disorders
  • Having participated in a physiotherapy or rehabilitation program in previous 2 months

研究组 & 干预措施

Education

Other

Education

干预措施: Education Classes (Other)

Physiotherapy Interventions

Experimental

Physiotherapy Interventions including strengthening exercise, balance training, gait training with visual cue, gait training with treadmill.

干预措施: Physiotherapy Interventions (Other)

结局指标

主要结局

Movement Disorder Society-Unified Parkinson's Disease Rating Scale

时间窗: Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention

Levodopa equivalent daily dosage (LEDD)

时间窗: Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention

次要结局

  • Activities-Specific Balance Confidence Scale (Chinese version)(Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention)
  • Number of Injurious Falls(Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention)
  • Timed Up and Go Test(Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention)
  • Parkinson's Disease Questionnaire (Standard Chinese Version)(Baseline. Immediate, 3-month, 6-month and 1 year Post-intervention)

研究者

发起方
Queen Elizabeth Hospital, Hong Kong
申办方类型
Other

研究点 (1)

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