- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05113524
Effects of Dance on the Turning Characteristics of Patients With Parkinson's Disease
The Effects of Dance on the Turning Characteristics of Patients With Parkinson's Disease During the Timed up and Go Test
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Experimental Design: control intervention non-randomized trial. Search Location: University of Wolverhaptom, Walsall Campus, United Kingdom; Federal University of Rio Grande do Sul, Brazil.
Participants: 15 adults aged between 50 and 80 years, with a clinical diagnosis of idiopathic PD, staging between 1 and 4 of the Hoehn & Yahr Scale, recruited from Dance for Parkinson's Projects, West-Midlands County, United Kingdom, and from Parkinson's UK (United Kingdom).
Interventions: Dance intervention for 3 months, 2 times/week (1 instructor lecture session and 1 home session following a prepared video), 2 hours per week. Controls, not alter their personal lifestyle, but undergo the same testing as the exercise intervention group.
Outcomes: clinical-functional parameters (number of steps and total time of the 180 turning phase of the Timed up and go Test - TUG - and biomechanics parameter - girdle dissociation) Data Analysis: Data will be described by average values and standard deviation values. All statistical analyses will be carried out using SPSS version 23, and Microsoft Excel Program version 16.44. The significance level is set at p<0.05. The Cohen's d is going to be used to predict effect interpreted as small d= 0.2, medium d=0.5, and large d=0.8, and 95% confidence intervals were presented.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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RS
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Porto Alegre, RS, Brazil, 90440-140
- Aline Nogueira Haas
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West Midlands
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Walsall, West Midlands, United Kingdom, WS1 3BD
- University of Wolverhampton, Walsall Campus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Confirmed diagnosis of PD according to the London Brain Bank Criteria;
- Able to understand the verbal instructions for the tests and to walk;
- Or attempt to walk independently with no walking aid.
Exclusion Criteria:
- Recent surgeries,
- Deep brain stimulation (DBS);
- Severe heart diseases, uncontrolled hypertension, myocardial infarction within a period of less than one year;
- Fitted with a pacemaker;
- Prostheses in the lower limbs;
- Stroke or other associated neurological diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Dance
Dance intervention for 3 months, 2 times/week (1 instructor lecture session and 1 home session following a prepared video), 2 hours per week.
Dance is a safe and effective form of activity, which has been used in PD population (Delabary et al., 2017; Sharp and Hewitt, 2014).
Participants take part in a dance class specifically for people with PD lead by a qualified dance instructor.
The dance class typically include a warm-up, dance related activities (specific to the genre of the class) and a cool-down.
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The dance program consists of 3 months of dance classes.
Classes are specifically designed for people with Parkisnon's and lead by a qualified dance instructor experienced in teaching this population.
The in-person dance classes are conducted in an appropriate room with chairs and ballet barres once a week.
In addition, the participants received a CD containing a video of the recorded dance routine to be performed at home once a week.
The class typically included a warm-up (10-15 min.),
barre ballet exercises (10-15 min.),
general dance-related activities (15-20 min), and a cool-down (10-15 min).
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ACTIVE_COMPARATOR: Control Group
Controls, not alter their personal lifestyle, but undergo the same testing as the exercise intervention group.
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Controls, not alter their personal lifestyle, but will undergo the same testing as the exercise intervention group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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180 turning phase of the Timed up and go Test (TUG)
Time Frame: Change from baseline at 3 months
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The beginning of the turning phase started from the last heel-strike of the regular straight line walking pattern.
The end of the turn was the final heel-off at the end of the turning motion, where the participant was ambulating in the opposite direction and prior to the cyclic straight line gait pattern resuming.
The exact time points were taken from the peak anterior-posterior linear velocity of the lower leg data corresponding with the specific heel-strike and heel-off instances.
The number of steps and the total time taken to complete the 180 turning phase of the TUG test were measured.
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Change from baseline at 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Girdle dissociation
Time Frame: Change from baseline at 3 months
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The girdle dissociation is a selected biomechanics parameter.
To obtain the value for the girdle dissociation, the difference between the orientation of the pelvis and the affected shoulder in the transverse plane, was calculated for each data point throughout the 180 turning phase of the TUG test.
The range between the maximum and minimum dissociation angles was reported and further analysed.
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Change from baseline at 3 months
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Collaborators and Investigators
Publications and helpful links
General Publications
- Dos Santos Delabary M, Komeroski IG, Monteiro EP, Costa RR, Haas AN. Effects of dance practice on functional mobility, motor symptoms and quality of life in people with Parkinson's disease: a systematic review with meta-analysis. Aging Clin Exp Res. 2018 Jul;30(7):727-735. doi: 10.1007/s40520-017-0836-2. Epub 2017 Oct 4.
- Dos Santos Delabary M, Monteiro EP, Donida RG, Wolffenbuttel M, Peyre-Tartaruga LA, Haas AN. Can Samba and Forro Brazilian rhythmic dance be more effective than walking in improving functional mobility and spatiotemporal gait parameters in patients with Parkinson's disease? BMC Neurol. 2020 Aug 18;20(1):305. doi: 10.1186/s12883-020-01878-y.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 33547920.9.0000.5347
- 12/18/NH/UOW (REGISTRY: CAAE number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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