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CompletedNCT03799887Updated Jan 10, 2019

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

An interventional study of 0% unweighed BWSTT and 10% unweighed BWSTT in Parkinson Disease, sponsored by Hitit University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-01-10.

Sponsored by Hitit University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 years 2 months after the study started (first participant enrolled Oct 2010, registered Jan 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Parkinson Disease

Keywords

  • Parkinson's disease
  • gait
  • balance
  • treadmill training
  • fatigue
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In context

Parkinson Disease

4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.

This study's enrollment of 35 is below the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Hitit University is the lead sponsor of 84 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
35 participants (actual)

Study arms

  • Active comparator
    0% unweighed BWSTT

    0% unweighed Body Weight Supported Treadmill Training

    Behavioral: 0% unweighed BWSTT

  • Experimental
    10% unweighed BWSTT

    0% unweighed Body Weight Supported Treadmill Training

    Behavioral: 10% unweighed BWSTT

  • Experimental
    20% unweighed BWSTT

    20% unweighed Body Weight Supported Treadmill Training

    Behavioral: 20% unweighed BWSTT

Interventions

  • Behavioral0% 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).

  • Behavioral10% 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).

  • Behavioral20% 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).

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What researchers measure

Primary outcomes

  1. 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 .

    Time frame: 6 weeks

  2. 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.

    Time frame: 6 weeks

  3. 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).

    Time frame: 6 weeks

Secondary outcomes

  1. 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.

    Time frame: 6 weeks

  2. 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).

    Time frame: 6 weeks

  3. 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 .

    Time frame: 6 weeks

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Study locations

1 site
  • Tuğba Atan
    Çorum, 19100, Turkey (Türkiye)
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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03799887
Lead sponsor
Hitit University
Responsible party
Tuğba Atan (Assoc. Prof., Hitit University) — Principal investigator
First posted
Jan 10, 2019
Start date
Oct 20, 2010
Primary completion
Oct 20, 2010
Completion
Nov 20, 2012
Last update
Jan 10, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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