Parkinson's DiseaseNCT01428648
Impact of Dance Therapy on Parkinson's Disease
A study testing Ballroom Dancing Classes in people with Parkinson's Disease, run by University of Arkansas at 1 site in United States.
Trial summary
Parkinson's disease (PD) affects ability of individuals to perform unconscious learned motor tasks, affects quality of life and has been associated with depression. The purpose of this study is to investigate the effect of dance therapy on motor performance, quality of life and depression in PD patients, by comparing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Ballroom Dancing Classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Mar 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older, both males and females, all races and all ethnicities
- Idiopathic Parkinson's disease diagnosed using United Kingdom Parkinson's Disease Society brain bank diagnostic criteria
- Mild to moderate disease severity (Stage 2 to 3 on the Modified Hoehn and Yahr scale)
- Stable medication regimen for a minimum of 1 month before testing
- Ability to ambulate independently without using a walking aid
- Ability to give informed consent
Who cannot join
- Prior enrollment in a dancing class during the last 6 months
- Presence of another neurological or medical disorder likely to affect gait or causing frequent falls (rheumatologic/orthopedic disease, stroke, myelopathy, severe neuropathy)
- Significant cognitive decline (MMSE ≤ 24)
- Visual deficit
- Hearing deficit that impairs music perception
- Psychotic symptoms
- Symptomatic heart disease
- Depression associated with suicidal ideation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Parkinson's disease (PD) affects ability of individuals to perform unconscious learned motor tasks, affects quality of life and has been associated with depression. The purpose of this study is to investigate the effect of dance therapy on motor performance, quality of life and depression in PD patients, by comparing certain symptoms between a group of subjects with PD who undergo ballroom dancing classes and a control group of subjects with PD. The investigators will assess mental status, severity of PD, quality of life and depression using rating scales. Subjects will be randomized to intervention and control group. Intervention group will participate in dance therapy for 12 weeks and will be examined at 12 and 20 weeks. Control group will be examined at same time intervals. Classes will follow a curriculum designed by Arthur Murray Dance Studio Staff. The investigators do not anticipate significant risk for participants.
- Conditions
- Parkinson's Disease
- Being tested
- Ballroom Dancing Classes
- Keywords
- Parkinson, ballroom dancing
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ballroom Dancing ClassesBehavioural
bi-weekly, 12-Week ballroom dance classes
| Study group | Role | What they receive |
|---|---|---|
| intervention | Active comparator | group of patients receiving ballroom dancing classes Receives: Behavioral: Ballroom Dancing Classes |
| control | No intervention | group of patients who will not receive dancing classes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of ballroom dancing classes on motor function in patients with Parkinson's disease.
The improvement in participant's motor function will be measured by the UPRS III score. The aim is to detect an 18-20% difference in UPDRS III scores among the two groups.
Measured: 3 and 5 months
Secondary outcomes (2)
Effect of ballroom dancing classes on depression in patients with Parkinson's disease.
The improvement in participant's depression will be measured by the Hamilton Depression Scale.
Measured: 3 and 5 months
Effect of ballroom dancing classes on quality of life of patients with Parkinson's disease.
The improvement in participant's quality of life will be measured by the Parkinson's Disease-39 questionnaire PDQ-39 scale.
Measured: 3 and 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startAug 2012
- Primary completionJan 2013
- Study completionMar 2013
Why it stopped: Recruitment slow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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 University of ArkansasThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy Maalouf, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428648
- Sponsor's protocol ID
- 133272
- Status last verified
- Mar 2015
- First submitted
- 2 Sep 2011
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gelb DJ, Oliver E, Gilman S. Diagnostic criteria for Parkinson disease. Arch Neurol. 1999 Jan;56(1):33-9. doi: 10.1001/archneur.56.1.33.
PubMed 9923759Park A, Stacy M. Non-motor symptoms in Parkinson's disease. J Neurol. 2009 Aug;256 Suppl 3:293-8. doi: 10.1007/s00415-009-5240-1.
PubMed 19711119Ransmayr G. Physical, occupational, speech and swallowing therapies and physical exercise in Parkinson's disease. J Neural Transm (Vienna). 2011 May;118(5):773-81. doi: 10.1007/s00702-011-0622-9. Epub 2011 Apr 3.
PubMed 21461962Ellgring H, Seiler S, Perleth B, Frings W, Gasser T, Oertel W. Psychosocial aspects of Parkinson's disease. Neurology. 1993 Dec;43(12 Suppl 6):S41-4.
PubMed 8264910Barichella M, Cereda E, Pezzoli G. Major nutritional issues in the management of Parkinson's disease. Mov Disord. 2009 Oct 15;24(13):1881-92. doi: 10.1002/mds.22705.
PubMed 19691125Joanna Briggs Institute. The Joanna Briggs Institute Best Practice Information Sheet: music as an intervention in hospitals. Nurs Health Sci. 2011 Mar;13(1):99-102. doi: 10.1111/j.1442-2018.2011.00583.x.
PubMed 21426462Marwick C. Leaving concert hall for clinic, therapists now test music's 'charms'. JAMA. 1996 Jan 24-31;275(4):267-8. No abstract available.
PubMed 8544252Bradt J, Dileo C, Grocke D. Music interventions for mechanically ventilated patients. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD006902. doi: 10.1002/14651858.CD006902.pub2.
PubMed 21154376Nilsson U. The anxiety- and pain-reducing effects of music interventions: a systematic review. AORN J. 2008 Apr;87(4):780-807. doi: 10.1016/j.aorn.2007.09.013.
PubMed 18395022Glover H, Kalinowski J, Rastatter M, Stuart A. Effect of instruction to sing on stuttering frequency at normal and fast rates. Percept Mot Skills. 1996 Oct;83(2):511-22. doi: 10.2466/pms.1996.83.2.511.
PubMed 8902026
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dance Therapy on Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01428648
- Acronym / sponsor ID
- 133272
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson, ballroom dancing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment slow
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 5 Sep 2011 (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.
Parkinson's disease (PD) affects ability of individuals to perform unconscious learned motor tasks, affects quality of life and has been associated with depression. The purpose of this study is to investigate the effect of dance therapy on motor performance, quality of life and depression in PD patients, by comparing certain symptoms between a group of subjects with PD who undergo ballroom dancing classes and a control group of subjects with PD. The investigators will assess mental status, severity of PD, quality of life and depression using rating scales. Subjects will be randomized to intervention and control group. Intervention group will participate in dance therapy for 12 weeks and will be examined at 12 and 20 weeks. Control group will be examined at same time intervals. Classes will follow a curriculum designed by Arthur Murray Dance Studio Staff. The investigators do not anticipate significant risk for participants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Active comparator | Behavioral: Ballroom Dancing Classesgroup of patients receiving ballroom dancing classes |
| control | No intervention | –group of patients who will not receive dancing classes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years and older, both males and females, all races and all ethnicities
- Idiopathic Parkinson's disease diagnosed using United Kingdom Parkinson's Disease Society brain bank diagnostic criteria
- Mild to moderate disease severity (Stage 2 to 3 on the Modified Hoehn and Yahr scale)
- Stable medication regimen for a minimum of 1 month before testing
- Ability to ambulate independently without using a walking aid
Key exclusion criteria (8 listed)
- Prior enrollment in a dancing class during the last 6 months
- Presence of another neurological or medical disorder likely to affect gait or causing frequent falls (rheumatologic/orthopedic disease, stroke, myelopathy, severe neuropathy)
- Significant cognitive decline (MMSE ≤ 24)
- Visual deficit
- Hearing deficit that impairs music perception
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 |
|---|---|---|
| Ballroom Dancing Classesbi-weekly, 12-Week ballroom dance classes | Behavioural | intervention |
Primary outcome
Effect of ballroom dancing classes on motor function in patients with Parkinson's disease.
Time frame: 3 and 5 months
The improvement in participant's motor function will be measured by the UPRS III score. The aim is to detect an 18-20% difference in UPDRS III scores among the two groups.
2 secondary outcomes
Effect of ballroom dancing classes on depression in patients with Parkinson's disease.
Time frame: 3 and 5 months
Effect of ballroom dancing classes on quality of life of patients with Parkinson's disease.
Time frame: 3 and 5 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
- Background: PubMed 9923759Gelb DJ, Oliver E, Gilman S. Diagnostic criteria for Parkinson disease. Arch Neurol. 1999 Jan;56(1):33-9. doi: 10.1001/archneur.56.1.33.
- Background: PubMed 19711119Park A, Stacy M. Non-motor symptoms in Parkinson's disease. J Neurol. 2009 Aug;256 Suppl 3:293-8. doi: 10.1007/s00415-009-5240-1.
- Background: PubMed 21461962Ransmayr G. Physical, occupational, speech and swallowing therapies and physical exercise in Parkinson's disease. J Neural Transm (Vienna). 2011 May;118(5):773-81. doi: 10.1007/s00702-011-0622-9. Epub 2011 Apr 3.
- Background: PubMed 8264910Ellgring H, Seiler S, Perleth B, Frings W, Gasser T, Oertel W. Psychosocial aspects of Parkinson's disease. Neurology. 1993 Dec;43(12 Suppl 6):S41-4.
- Background: PubMed 19691125Barichella M, Cereda E, Pezzoli G. Major nutritional issues in the management of Parkinson's disease. Mov Disord. 2009 Oct 15;24(13):1881-92. doi: 10.1002/mds.22705.
- Background: PubMed 21426462Joanna Briggs Institute. The Joanna Briggs Institute Best Practice Information Sheet: music as an intervention in hospitals. Nurs Health Sci. 2011 Mar;13(1):99-102. doi: 10.1111/j.1442-2018.2011.00583.x.
- Background: PubMed 8544252Marwick C. Leaving concert hall for clinic, therapists now test music's 'charms'. JAMA. 1996 Jan 24-31;275(4):267-8. No abstract available.
- Background: PubMed 21154376Bradt J, Dileo C, Grocke D. Music interventions for mechanically ventilated patients. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD006902. doi: 10.1002/14651858.CD006902.pub2.
- Background: PubMed 18395022Nilsson U. The anxiety- and pain-reducing effects of music interventions: a systematic review. AORN J. 2008 Apr;87(4):780-807. doi: 10.1016/j.aorn.2007.09.013.
- Background: PubMed 8902026Glover H, Kalinowski J, Rastatter M, Stuart A. Effect of instruction to sing on stuttering frequency at normal and fast rates. Percept Mot Skills. 1996 Oct;83(2):511-22. doi: 10.2466/pms.1996.83.2.511.
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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.
Nancy Maalouf, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ballroom Dancing Classes in people with Parkinson's Disease, run by University of Arkansas at 1 site in United States.
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 6 inclusion and 8 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: withdrawn, as of the sponsor's last update on 4 Mar 2015. 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 United States. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Effect of ballroom dancing classes on motor function in patients with Parkinson's disease. (time frame: 3 and 5 months). 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 NCT01428648, which also lists 10 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 4 Mar 2015.