- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00750945
Treadmill and Music Cueing for Gait Training in Mild to Moderate Parkinson's Disease
September 25, 2009 updated by: Chulalongkorn University
Treadmill and Music Cueing for Gait Training in Mild to Moderate Parkinson's Disease: a Preliminary Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Bangkok, Thailand, 10330
- Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A
Treadmill with Music cueing group
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Treadmill with Music cueing training 3 days/wk, plus home music cueing 3 days/wk x 4 weeks
Other Names:
|
|
Active Comparator: B
Treadmill group
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Treadmill training 3 days/wk, plus home walking 3 days/wk x 4 weeks
Other Names:
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Placebo Comparator: C
Home walking group
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Home walking program 6 days/wk x 4 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
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within 1 week after training, and at 4 weeks follow up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Balance (single leg stance time) and fall rate
Time Frame: within 1 week after training, and at 4 weeks follow up
|
within 1 week after training, and at 4 weeks follow up
|
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Aerobic endurance (6 minute walk test)
Time Frame: AA) within 1 week after training, and at 4 weeks follow up
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AA) within 1 week after training, and at 4 weeks follow up
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Mentation, mood, behavior, Motor and ADL subscale of UPDRS
Time Frame: within 1 week after training, and at 4 weeks follow up
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within 1 week after training, and at 4 weeks follow up
|
|
Patient's satisfaction
Time Frame: within 1 week after training, and at 4 weeks follow up
|
within 1 week after training, and at 4 weeks follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dootchai Chaiwanichsiri, MD, Chulalongkorn University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
September 10, 2008
First Submitted That Met QC Criteria
September 10, 2008
First Posted (Estimate)
September 11, 2008
Study Record Updates
Last Update Posted (Estimate)
September 28, 2009
Last Update Submitted That Met QC Criteria
September 25, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COA No. 623/2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.