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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05113524
Other study ID # 33547920.9.0000.5347
Secondary ID 12/18/NH/UOW
Status Completed
Phase N/A
First received
Last updated
Start date December 10, 2018
Est. completion date June 30, 2020

Study information

Verified date May 2022
Source Federal University of Rio Grande do Sul
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed control intervention trial, aims to analyse the effects of Dance in the turning characteristics in patients with Parkinson Disease (PD) using three- dimensional (3D) analysis during the timed up and go (TUG) test.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date June 30, 2020
Est. primary completion date May 1, 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Dance
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).
No intervention
Controls, not alter their personal lifestyle, but will undergo the same testing as the exercise intervention group.

Locations

Country Name City State
Brazil Aline Nogueira Haas Porto Alegre RS
United Kingdom University of Wolverhampton, Walsall Campus Walsall West Midlands

Sponsors (3)

Lead Sponsor Collaborator
Federal University of Rio Grande do Sul Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., University of Wolverhampton

Countries where clinical trial is conducted

Brazil,  United Kingdom, 

References & Publications (2)

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. Review. — View Citation

Dos Santos Delabary M, Monteiro EP, Donida RG, Wolffenbuttel M, Peyré-Tartaruga LA, Haas AN. Can Samba and Forró 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 180 turning phase of the Timed up and go Test (TUG) 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. Change from baseline at 3 months
Secondary Girdle dissociation 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. Change from baseline at 3 months
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