NCT00750945

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

September 28, 2009

Status Verified

July 1, 2009

Enrollment Period

8 months

First QC Date

September 10, 2008

Last Update Submit

September 25, 2009

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseCueing trainingTreadmill trainingMusic

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Balance (single leg stance time) and fall rate

    within 1 week after training, and at 4 weeks follow up

  • Aerobic endurance (6 minute walk test)

    AA) within 1 week after training, and at 4 weeks follow up

  • Mentation, mood, behavior, Motor and ADL subscale of UPDRS

    within 1 week after training, and at 4 weeks follow up

  • Patient's satisfaction

    within 1 week after training, and at 4 weeks follow up

Study Arms (3)

A

EXPERIMENTAL

Treadmill with Music cueing group

Other: Music and treadmill walking program

B

ACTIVE COMPARATOR

Treadmill group

Other: Treadmill walking program

C

PLACEBO COMPARATOR

Home walking group

Other: Home program

Interventions

Music and treadmill walking programOTHER

Treadmill with Music cueing training 3 days/wk, plus home music cueing 3 days/wk x 4 weeks

Also known as: Music cueing
A
Treadmill walking programOTHER

Treadmill training 3 days/wk, plus home walking 3 days/wk x 4 weeks

Also known as: Treadmill
B
Home programOTHER

Home walking program 6 days/wk x 4 weeks

C

Eligibility Criteria

Age60 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Medication change during the study program
  • Inability to walk on treadmill (in treadmill groups)
  • Cannot complete 80% of the prescribed program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University

Bangkok, Bangkok, 10330, Thailand

Location

Related Publications (2)

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

    PMID: 38588457DERIVED

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

    PMID: 36602886DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Dootchai Chaiwanichsiri, MD

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2008

First Posted

September 11, 2008

Study Start

September 1, 2008

Primary Completion

May 1, 2009

Study Completion

July 1, 2009

Last Updated

September 28, 2009

Record last verified: 2009-07

Locations

TH(1)