Effects of Different Percentages Body Weight Supported Treadmill Training on Gait, Balance, Quality of Life and Fatigue in Parkinson's Disease
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable parkinson-disease
Started Oct 2010
Typical duration for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2012
CompletedFirst Submitted
Initial submission to the registry
January 8, 2019
CompletedFirst Posted
Study publicly available on registry
January 10, 2019
CompletedJanuary 10, 2019
January 1, 2019
Same day
January 8, 2019
January 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 .
6 weeks
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.
6 weeks
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).
6 weeks
Secondary Outcomes (3)
Nottingham Health Profile (NHP):
6 weeks
Fatigue Impact Scale (FIS):
6 weeks
Fatigue Severity Scale (FSS):
6 weeks
Study Arms (3)
0% unweighed BWSTT
ACTIVE COMPARATOR0% unweighed Body Weight Supported Treadmill Training
10% unweighed BWSTT
EXPERIMENTAL0% unweighed Body Weight Supported Treadmill Training
20% unweighed BWSTT
EXPERIMENTAL20% unweighed Body Weight Supported Treadmill Training
Interventions
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).
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).
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hitit Universitylead
Study Sites (1)
Tuğba Atan
Çorum, 19100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof.
Study Record Dates
First Submitted
January 8, 2019
First Posted
January 10, 2019
Study Start
October 20, 2010
Primary Completion
October 20, 2010
Study Completion
November 20, 2012
Last Updated
January 10, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will share