Back to resultsTreadmill and Music Cueing for Gait Training in Mild to Moderate Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Music and treadmill walking program
Treadmill walking program
Home program
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Cueing training, Treadmill training, Music
Eligibility Criteria
Inclusion Criteria:
- Male PD patients aged 60-80 years with Hoehn and Yahr stage 2-3 diagnosed by attending neurologist
- Good cognitive function with Thai Mental State Examination >23
- Stable medication without freezing
- No prior exercise program within the last 2 months
- No contraindication for exercise
Exclusion Criteria:
- Medication change during the study program
- Inability to walk on treadmill (in treadmill groups)
- Cannot complete 80% of the prescribed program
Sites / Locations
- Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
A
B
C
Arm Description
Treadmill with Music cueing group
Treadmill group
Home walking group
Outcomes
Primary Outcome Measures
Walking performance evaluated with Timed Up and Go test, walking speed, step length, and cadence.
Secondary Outcome Measures
Balance (single leg stance time) and fall rate
Aerobic endurance (6 minute walk test)
Mentation, mood, behavior, Motor and ADL subscale of UPDRS
Patient's satisfaction
Full Information
NCT ID
NCT00750945
First Posted
September 10, 2008
Last Updated
September 25, 2009
Sponsor
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT00750945
Brief Title
Treadmill and Music Cueing for Gait Training in Mild to Moderate Parkinson's Disease
Official Title
Treadmill and Music Cueing for Gait Training in Mild to Moderate Parkinson's Disease: a Preliminary Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chulalongkorn University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Sensory and motor cueing have been demonstrated as useful ambulation training techniques for Parkinson's disease (PD). This study is aimed to evaluate the effectiveness of treadmill training program with music cueing for mild to moderate PD patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Cueing training, Treadmill training, Music
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Treadmill with Music cueing group
Arm Title
B
Arm Type
Active Comparator
Arm Description
Treadmill group
Arm Title
C
Arm Type
Placebo Comparator
Arm Description
Home walking group
Intervention Type
Other
Intervention Name(s)
Music and treadmill walking program
Other Intervention Name(s)
Music cueing
Intervention Description
Treadmill with Music cueing training 3 days/wk, plus home music cueing 3 days/wk x 4 weeks
Intervention Type
Other
Intervention Name(s)
Treadmill walking program
Other Intervention Name(s)
Treadmill
Intervention Description
Treadmill training 3 days/wk, plus home walking 3 days/wk x 4 weeks
Intervention Type
Other
Intervention Name(s)
Home program
Intervention Description
Home walking program 6 days/wk x 4 weeks
Primary Outcome Measure Information:
Title
Walking performance evaluated with Timed Up and Go test, walking speed, step length, and cadence.
Time Frame
within 1 week after training, and at 4 weeks follow up
Secondary Outcome Measure Information:
Title
Balance (single leg stance time) and fall rate
Time Frame
within 1 week after training, and at 4 weeks follow up
Title
Aerobic endurance (6 minute walk test)
Time Frame
AA) within 1 week after training, and at 4 weeks follow up
Title
Mentation, mood, behavior, Motor and ADL subscale of UPDRS
Time Frame
within 1 week after training, and at 4 weeks follow up
Title
Patient's satisfaction
Time Frame
within 1 week after training, and at 4 weeks follow up
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male PD patients aged 60-80 years with Hoehn and Yahr stage 2-3 diagnosed by attending neurologist
Good cognitive function with Thai Mental State Examination >23
Stable medication without freezing
No prior exercise program within the last 2 months
No contraindication for exercise
Exclusion Criteria:
Medication change during the study program
Inability to walk on treadmill (in treadmill groups)
Cannot complete 80% of the prescribed program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dootchai Chaiwanichsiri, MD
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Treadmill and Music Cueing for Gait Training in Mild to Moderate Parkinson's Disease
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