Parkinson's DiseaseNCT00750945
Treadmill and Music Cueing for Gait Training in Mild to Moderate Parkinson's Disease
A study testing Music and treadmill walking program, Treadmill walking program and Home program in people with Parkinson's Disease, run by Chulalongkorn University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years, men only
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Music and treadmill walking program, Treadmill walking program and Home program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2008to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Medication change during the study program
- Inability to walk on treadmill (in treadmill groups)
- Cannot complete 80% of the prescribed program
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University
Bangkok, Bangkok, 10330
About this study
Official title: 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.
- Conditions
- Parkinson's Disease
- Being tested
- Music and treadmill walking program, Treadmill walking program, Home program
- Keywords
- Parkinson's disease, Cueing training, Treadmill training, Music
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music and treadmill walking programOther
Also called Music cueing
Treadmill with Music cueing training 3 days/wk, plus home music cueing 3 days/wk x 4 weeks
Treadmill walking programOther
Also called Treadmill
Treadmill training 3 days/wk, plus home walking 3 days/wk x 4 weeks
Home programOther
Home walking program 6 days/wk x 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Treadmill with Music cueing group Receives: Other: Music and treadmill walking program |
| B | Active comparator | Treadmill group Receives: Other: Treadmill walking program |
| C | Placebo comparator | Home walking group Receives: Other: Home program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking performance evaluated with Timed Up and Go test, walking speed, step length, and cadence.
Measured: within 1 week after training, and at 4 weeks follow up
Secondary outcomes (4)
Balance (single leg stance time) and fall rate
Measured: within 1 week after training, and at 4 weeks follow up
Aerobic endurance (6 minute walk test)
Measured: AA) within 1 week after training, and at 4 weeks follow up
Mentation, mood, behavior, Motor and ADL subscale of UPDRS
Measured: within 1 week after training, and at 4 weeks follow up
Patient's satisfaction
Measured: within 1 week after training, and at 4 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Investigators
- Dootchai Chaiwanichsiri, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750945
- Sponsor's protocol ID
- COA No. 623/2008
- Status last verified
- Jul 2009
- First submitted
- 10 Sep 2008
- Last updated
- 28 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38588457Ernst 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.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treadmill and Music Cueing for Gait Training in Mild to Moderate Parkinson's Disease: a Preliminary Study
- ClinicalTrials.gov ID
- NCT00750945
- Acronym / sponsor ID
- COA No. 623/2008
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Cueing training, Treadmill training, Music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 11 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: Music and treadmill walking programTreadmill with Music cueing group |
| B | Active comparator | Other: Treadmill walking programTreadmill group |
| C | Placebo comparator | Other: Home programHome walking group |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Medication change during the study program
- Inability to walk on treadmill (in treadmill groups)
- Cannot complete 80% of the prescribed program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music and treadmill walking programAlso: Music cueingTreadmill with Music cueing training 3 days/wk, plus home music cueing 3 days/wk x 4 weeks | Other | A |
| Treadmill walking programAlso: TreadmillTreadmill training 3 days/wk, plus home walking 3 days/wk x 4 weeks | Other | B |
| Home programHome walking program 6 days/wk x 4 weeks | Other | C |
Primary outcome
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
4 secondary outcomes
Balance (single leg stance time) and fall rate
Time frame: within 1 week after training, and at 4 weeks follow up
Aerobic endurance (6 minute walk test)
Time frame: AA) within 1 week after training, and at 4 weeks follow up
Mentation, mood, behavior, Motor and ADL subscale of UPDRS
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2009.
- Derived from this study: PubMed 38588457Ernst 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.
- Derived from this study: PubMed 36602886Ernst 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dootchai Chaiwanichsiri, MD principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music and treadmill walking program, Treadmill walking program and Home program in people with Parkinson's Disease, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00750945, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2009.