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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00750945
Other study ID # COA No. 623/2008
Secondary ID
Status Completed
Phase N/A
First received September 10, 2008
Last updated September 25, 2009
Start date September 2008
Est. completion date July 2009

Study information

Verified date July 2009
Source Chulalongkorn University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Male
Age group 60 Years to 80 Years
Eligibility Inclusion Criteria:

1. Male PD patients aged 60-80 years with Hoehn and Yahr stage 2-3 diagnosed by attending neurologist

2. Good cognitive function with Thai Mental State Examination >23

3. Stable medication without freezing

4. No prior exercise program within the last 2 months

5. No contraindication for exercise

Exclusion Criteria:

1. Medication change during the study program

2. Inability to walk on treadmill (in treadmill groups)

3. Cannot complete 80% of the prescribed program

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Music and treadmill walking program
Treadmill with Music cueing training 3 days/wk, plus home music cueing 3 days/wk x 4 weeks
Treadmill walking program
Treadmill training 3 days/wk, plus home walking 3 days/wk x 4 weeks
Home program
Home walking program 6 days/wk x 4 weeks

Locations

Country Name City State
Thailand Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Walking performance evaluated with Timed Up and Go test, walking speed, step length, and cadence. within 1 week after training, and at 4 weeks follow up No
Secondary Balance (single leg stance time) and fall rate within 1 week after training, and at 4 weeks follow up No
Secondary Aerobic endurance (6 minute walk test) AA) within 1 week after training, and at 4 weeks follow up No
Secondary Mentation, mood, behavior, Motor and ADL subscale of UPDRS within 1 week after training, and at 4 weeks follow up No
Secondary Patient's satisfaction within 1 week after training, and at 4 weeks follow up No
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