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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Behavioral: 20% unweighed BWSTT; Behavioral: 0% unweighed BWSTT; Behavioral: 10% unweighed BWSTT

• Registration Number: NCT03799887
• Lead Sponsor: Hitit University

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.

Study Timeline

• Study Start: 2010-10-20
• Primary Completion: 2010-10-20
• Study Completion: 2012-11-20
• Status Verified: 2019-01
• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-09
• Last Update Submitted: 2019-01-09
• Study First Posted: 2019-01-10
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
20% unweighed BWSTT	20% unweighed BWSTT	20% unweighed Body Weight Supported Treadmill Training
0% unweighed BWSTT	0% unweighed BWSTT	0% unweighed Body Weight Supported Treadmill Training
10% unweighed BWSTT	10% unweighed BWSTT	0% unweighed Body Weight Supported Treadmill Training

Primary Outcome Measures

Name	Time	Method
6 Minute Walk Test (6MWT)	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):	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):	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 Outcome Measures

Name	Time	Method
Nottingham Health Profile (NHP):	6 weeks	It contains 38 items that address pain, physical mobility, emotional reactions, energy, social isolation, and sleep dimensions. Higher scores indicate worse quality of life.
Fatigue Impact Scale (FIS):	6 weeks	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).
Fatigue Severity Scale (FSS):	6 weeks	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 .

Trial Locations

Locations (1)

Tuğba Atan; 🇹🇷 Çorum, Turkey