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Completed

NCT Number: NCT03799887

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Fatigue Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tuğba Atan

Çorum, 19100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0% unweighed BWSTT

Behavioral

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).

10% unweighed BWSTT

Behavioral

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).

20% unweighed BWSTT

Behavioral

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).

Primary outcomes

  1. 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 .

  2. 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.

  3. 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

  1. Nottingham Health Profile (NHP):

    Time frame: 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.

  2. Fatigue Impact Scale (FIS):

    Time frame: 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).

  3. Fatigue Severity Scale (FSS):

    Time frame: 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 .

Sponsors and collaborators

Lead sponsor

Hitit University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2012
First posted
Jan 10, 2019
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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