- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01428648
Impact of Dance Therapy on Parkinson's Disease
March 3, 2015 updated by: University of Arkansas
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 Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: intervention
group of patients receiving ballroom dancing classes
|
bi-weekly, 12-Week ballroom dance classes
|
|
NO_INTERVENTION: control
group of patients who will not receive dancing classes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 and 5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of ballroom dancing classes on depression in patients with Parkinson's disease.
Time Frame: 3 and 5 months
|
The improvement in participant's depression will be measured by the Hamilton Depression Scale.
|
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
|
The improvement in participant's quality of life will be measured by the Parkinson's Disease-39 questionnaire PDQ-39 scale.
|
3 and 5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nancy Maalouf, MD, University of Arkansas
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nilsson 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.
- 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.
- Park 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.
- Ransmayr 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.
- Ellgring 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.
- Barichella 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.
- Joanna 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.
- Marwick C. Leaving concert hall for clinic, therapists now test music's 'charms'. JAMA. 1996 Jan 24-31;275(4):267-8. No abstract available.
- Bradt 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.
- Glover 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (ACTUAL)
January 1, 2013
Study Completion (ACTUAL)
March 1, 2013
Study Registration Dates
First Submitted
September 2, 2011
First Submitted That Met QC Criteria
September 2, 2011
First Posted (ESTIMATE)
September 5, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
March 4, 2015
Last Update Submitted That Met QC Criteria
March 3, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 133272
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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