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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01428648
Other study ID # 133272
Secondary ID
Status Withdrawn
Phase N/A
First received September 2, 2011
Last updated March 3, 2015
Start date August 2012
Est. completion date March 2013

Study information

Verified date March 2015
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Ballroom Dancing Classes
bi-weekly, 12-Week ballroom dance classes

Locations

Country Name City State
United States University of Arkansas for Medical Sciences Little Rock Arkansas

Sponsors (1)

Lead Sponsor Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. Review. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2014;12:CD006902. — View Citation

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. — View Citation

Gelb DJ, Oliver E, Gilman S. Diagnostic criteria for Parkinson disease. Arch Neurol. 1999 Jan;56(1):33-9. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Marwick C. Leaving concert hall for clinic, therapists now test music's 'charms'. JAMA. 1996 Jan 24-31;275(4):267-8. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 and 5 months No
Secondary 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. 3 and 5 months No
Secondary 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. 3 and 5 months No
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