Effects of Different Percentages Body Weight Supported Treadmill Training on Gait, Balance, Quality of Life and Fatigue in Parkinson's Disease: A Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- 6 Minute Walk Test (6MWT)
研究概览
简要总结
Body weight supported treadmill training (BWSTT) is an important rehabilitative choice for neurologically impaired subjects such as Parkinson's disease (PD). The aim of the study is to evaluate the effectiveness of different percentages BWSTT on gait, balance, quality of life and fatigue in moderate to advanced PD.
详细描述
Body weight supported treadmill training (BWSTT) is an important rehabilitative choice for neurologically impaired subjects such as Parkinson's disease (PD). The aim of the study is to evaluate the effectiveness of different percentages BWSTT on gait, balance, quality of life and fatigue in moderate to advanced PD. Thirty five patients were randomly assigned to one of the three groups according to the percentage unweighed: 0% BWSTT, 10% BWSTT and 20% BWSTT. All patients participated 30 minutes BWSTT sessions 5 days a week, for 6 weeks. Primary outcomes were 6 minute walk test (6MWT), Berg balance scale (BBS), Unified Parkinson's Disease Rating Scale (UPDRS); and secondary outcomes were Nottingham health profile (NHP), Fatigue Impact Scale (FIS) and Fatigue Severity Scale (FSS) which were performed at the beginning and end of the rehabilitation.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Parkinson's disease according to the UK Brain Bank criteria.
- •Subjects had clinically moderate to advanced severity of disease (Hoehn and Yahr stage 2 - 4).
- •Subjects whose medical treatment had been on stable dosage of dopaminomimetics for at least 4 weeks before the study.
- •Subjects ability to walk with or without assistive device.
排除标准
- •Subjects had cardiovascular, inflammatory or musculoskeletal problems that could prevent them to participate in an exercise program.
- •Subjects whose mini mental status examination score was less than 26.
研究组 & 干预措施
0% unweighed BWSTT
0% unweighed Body Weight Supported Treadmill Training
干预措施: 0% unweighed BWSTT (Behavioral)
10% unweighed BWSTT
0% unweighed Body Weight Supported Treadmill Training
干预措施: 10% unweighed BWSTT (Behavioral)
20% unweighed BWSTT
20% unweighed Body Weight Supported Treadmill Training
干预措施: 20% unweighed BWSTT (Behavioral)
结局指标
主要结局
6 Minute Walk Test (6MWT)
时间窗: 6 weeks
Functional exercise capacity was assessed by distance walked in 6 minutes (6MWT). The patient was asked to walk as long as possible for 6 minutes on a 30 meters of marked and flat ground, at a self selected speed. 6MWT is a submaximal exercise test and can be used to assess treatment response .
Berg Balance Scale (BBS):
时间窗: 6 weeks
It contains 14 instructions and 0 - 4 points is given for each instruction according to the performance of the patients. 0 points are given when the patient totally could not do the activity while 4 points are given when the patient completes the activity independently.
Unified Parkinson's Disease Rating Scale (UPDRS):
时间窗: 6 weeks
It is used to follow the clinical status of PD. It consists of four main parts (totally 183 points): mentation, behavior and mood (UPDRS I: 16 points), activities of daily living (UPDRS II: 52 points), motor examination (UPDRS III: 92 points), treatment complications (UPDRS IV: 23 points).
次要结局
- Nottingham Health Profile (NHP):(6 weeks)
- Fatigue Impact Scale (FIS):(6 weeks)
- Fatigue Severity Scale (FSS):(6 weeks)
研究者
Tuğba Atan
Assoc. Prof.
Hitit University