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Treadmill and Music Cueing for Gait Training in Mild to Moderate Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT00750945
First received: September 10, 2008
Last updated: September 25, 2009
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention
Parkinson's Disease
 Other: Music and treadmill walking program
Other: Treadmill walking program
Other: Home program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treadmill and Music Cueing for Gait Training in Mild to Moderate Parkinson's Disease: a Preliminary Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Balance (single leg stance time) and fall rate [ Time Frame: within 1 week after training, and at 4 weeks follow up ] [ Designated as safety issue: No ]
  • Aerobic endurance (6 minute walk test) [ Time Frame: AA) within 1 week after training, and at 4 weeks follow up ] [ Designated as safety issue: No ]
  • Mentation, mood, behavior, Motor and ADL subscale of UPDRS [ Time Frame: within 1 week after training, and at 4 weeks follow up ] [ Designated as safety issue: No ]
  • Patient's satisfaction [ Time Frame: within 1 week after training, and at 4 weeks follow up ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2008
Study Completion Date: July 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Treadmill with Music cueing group
 Other: Music and treadmill walking program
Treadmill with Music cueing training 3 days/wk, plus home music cueing 3 days/wk x 4 weeks
Other Name: Music cueing
Active Comparator: B
Treadmill group
 Other: Treadmill walking program
Treadmill training 3 days/wk, plus home walking 3 days/wk x 4 weeks
Other Name: Treadmill
Placebo Comparator: C
Home walking group
 Other: Home program
Home walking program 6 days/wk x 4 weeks
Other Name: Home program

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00750945

Locations
Thailand
Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Dootchai Chaiwanichsiri, MD Chulalongkorn University
  More Information

No publications provided

Responsible Party: Dootchai Chaiwanichsiri, MD, Faculty of Medicine, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT00750945     History of Changes
Other Study ID Numbers: COA No. 623/2008
Study First Received: September 10, 2008
Last Updated: September 25, 2009
Health Authority: Thailand: Ethical Committee

Keywords provided by Chulalongkorn University:
Parkinson's disease
Cueing training
Treadmill training
Music

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 16, 2013