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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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
0% unweighed BWSTT
10% unweighed BWSTT
20% unweighed BWSTT
Sponsored by
Hitit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, gait, balance, treadmill training, fatigue

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tuğba Atan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

0% unweighed BWSTT

10% unweighed BWSTT

20% unweighed BWSTT

Arm Description

0% unweighed Body Weight Supported Treadmill Training

0% unweighed Body Weight Supported Treadmill Training

20% unweighed Body Weight Supported Treadmill Training

Outcomes

Primary Outcome Measures

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 .
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.
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).

Secondary Outcome Measures

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.
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).
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 .

Full Information

First Posted
January 8, 2019
Last Updated
January 9, 2019
Sponsor
Hitit University
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1. Study Identification

Unique Protocol Identification Number
NCT03799887
Brief Title
Effects of Different Percentages Body Weight Supported Treadmill Training on Gait, Balance, Quality of Life and Fatigue in Parkinson's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 20, 2010 (Actual)
Primary Completion Date
October 20, 2010 (Actual)
Study Completion Date
November 20, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hitit University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, gait, balance, treadmill training, fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0% unweighed BWSTT
Arm Type
Active Comparator
Arm Description
0% unweighed Body Weight Supported Treadmill Training
Arm Title
10% unweighed BWSTT
Arm Type
Experimental
Arm Description
0% unweighed Body Weight Supported Treadmill Training
Arm Title
20% unweighed BWSTT
Arm Type
Experimental
Arm Description
20% unweighed Body Weight Supported Treadmill Training
Intervention Type
Behavioral
Intervention Name(s)
0% unweighed BWSTT
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
10% unweighed BWSTT
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
20% unweighed BWSTT
Intervention Description
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 Measure Information:
Title
6 Minute Walk Test (6MWT)
Description
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
Title
Berg Balance Scale (BBS):
Description
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
Title
Unified Parkinson's Disease Rating Scale (UPDRS):
Description
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 Outcome Measure Information:
Title
Nottingham Health Profile (NHP):
Description
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
Title
Fatigue Impact Scale (FIS):
Description
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
Title
Fatigue Severity Scale (FSS):
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Tuğba Atan
City
Çorum
ZIP/Postal Code
19100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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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