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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

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ClinicalTrials.gov Identifier: NCT03799887
Recruitment Status : Completed
First Posted : January 10, 2019
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Tuğba Atan, 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Behavioral: 0% unweighed BWSTT Behavioral: 10% unweighed BWSTT Behavioral: 20% unweighed BWSTT Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 20, 2010
Actual Primary Completion Date : October 20, 2010
Actual Study Completion Date : November 20, 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 0% unweighed BWSTT
0% unweighed Body Weight Supported Treadmill Training
Behavioral: 0% unweighed BWSTT

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).


Experimental: 10% unweighed BWSTT
0% unweighed Body Weight Supported Treadmill Training
Behavioral: 10% unweighed BWSTT

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).


Experimental: 20% unweighed BWSTT
20% unweighed Body Weight Supported Treadmill Training
Behavioral: 20% unweighed BWSTT

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 Outcome Measures :
  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 Outcome Measures :
  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 .



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799887


Locations
Turkey
Tuğba Atan
Çorum, Turkey, 19100
Sponsors and Collaborators
Hitit University

Responsible Party: Tuğba Atan, Assoc. Prof., Hitit University
ClinicalTrials.gov Identifier: NCT03799887     History of Changes
Other Study ID Numbers: 2010-171
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tuğba Atan, Hitit University:
Parkinson's disease
gait
balance
treadmill training
fatigue

Additional relevant MeSH terms:
Parkinson Disease
Fatigue
Body Weight
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Signs and Symptoms