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Clinical Trials/NCT03799887
NCT03799887
Completed
Not Applicable

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

Hitit University1 site in 1 country35 target enrollmentOctober 20, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Hitit University
Enrollment
35
Locations
1
Primary Endpoint
6 Minute Walk Test (6MWT)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2010
End Date
November 20, 2012
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hitit University
Responsible Party
Principal Investigator
Principal Investigator

Tuğba Atan

Assoc. Prof.

Hitit University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

6 Minute Walk Test (6MWT)

Time Frame: 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):

Time Frame: 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):

Time Frame: 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).

Secondary Outcomes

  • Nottingham Health Profile (NHP):(6 weeks)
  • Fatigue Impact Scale (FIS):(6 weeks)
  • Fatigue Severity Scale (FSS):(6 weeks)

Study Sites (1)

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