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Effects of Dance on the Turning Characteristics of Patients With Parkinson's Disease

Primary Purpose

Parkinson Disease(PD)

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Dance
No intervention
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease(PD) focused on measuring Dance, Functional Mobility, Turning

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aline Nogueira Haas
  • University of Wolverhampton, Walsall Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dance

Control Group

Arm Description

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.

Controls, not alter their personal lifestyle, but undergo the same testing as the exercise intervention group.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 28, 2021
Last Updated
May 17, 2022
Sponsor
Federal University of Rio Grande do Sul
Collaborators
University of Wolverhampton, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT05113524
Brief Title
Effects of Dance on the Turning Characteristics of Patients With Parkinson's Disease
Official Title
The Effects of Dance on the Turning Characteristics of Patients With Parkinson's Disease During the Timed up and Go Test
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 10, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul
Collaborators
University of Wolverhampton, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease(PD)
Keywords
Dance, Functional Mobility, Turning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dance
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Controls, not alter their personal lifestyle, but undergo the same testing as the exercise intervention group.
Intervention Type
Other
Intervention Name(s)
Dance
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
Controls, not alter their personal lifestyle, but will undergo the same testing as the exercise intervention group.
Primary Outcome Measure Information:
Title
180 turning phase of the Timed up and go Test (TUG)
Description
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.
Time Frame
Change from baseline at 3 months
Secondary Outcome Measure Information:
Title
Girdle dissociation
Description
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.
Time Frame
Change from baseline at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aline Nogueira Haas, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aline Nogueira Haas
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90440-140
Country
Brazil
Facility Name
University of Wolverhampton, Walsall Campus
City
Walsall
State/Province
West Midlands
ZIP/Postal Code
WS1 3BD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28980176
Citation
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.
Results Reference
background
PubMed Identifier
32811464
Citation
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.
Results Reference
background

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Effects of Dance on the Turning Characteristics of Patients With Parkinson's Disease

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