Effects of Different Percentages Body Weight Supported Treadmill Training on Gait, Balance, Quality of Life and Fatigue in Parkinson's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: 0% unweighed BWSTT
* Behavioral: 10% unweighed BWSTT
* Behavioral: 20% unweighed BWSTT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0% unweighed BWSTT<br>0% unweighed Body Weight Supported Treadmill Training | Behavioral: 0% unweighed BWSTT<br>* 30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises. After CRP, participants were provided 30 minutes 0% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions).<br>|
| Experimental: 10% unweighed BWSTT<br>0% unweighed Body Weight Supported Treadmill Training | Behavioral: 10% unweighed BWSTT<br>* 30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises. After CRP, participants were provided 30 minutes 10% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions).<br>|
| Experimental: 20% unweighed BWSTT<br>20% unweighed Body Weight Supported Treadmill Training | Behavioral: 20% unweighed BWSTT<br>* 30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises. After CRP, participants were provided 30 minutes 20% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Minute Walk Test (6MWT) | 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 . | 6 weeks | 
| Berg Balance Scale (BBS): | 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. | 6 weeks | 
| Unified Parkinson's Disease Rating Scale (UPDRS): | 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). | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nottingham Health Profile (NHP): | It contains 38 items that address pain, physical mobility, emotional reactions, energy, social isolation, and sleep dimensions. Higher scores indicate worse quality of life. | 6 weeks | 
| Fatigue Impact Scale (FIS): | This scale assesses the cognitive, physical and social effects of fatigue during the last one week in a total of 40 - item questionnaire (0 = no problem, 4 = maximum problem). | 6 weeks | 
| Fatigue Severity Scale (FSS): | This scale assesses the severity of fatigue during the last one week in a total of 9 - item questionnaire (1 = strongly disagree, 7 = strongly agree). The total score ranges from 9 - 63, in which higher score means higher severity of fatigue . | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, gait, balance, treadmill training, fatigue