NCT05113524

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 9, 2021

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

October 28, 2021

Last Update Submit

May 17, 2022

Conditions

Keywords

DanceFunctional MobilityTurning

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Girdle dissociation

    Change from baseline at 3 months

Study Arms (2)

Dance

EXPERIMENTAL

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.

Other: Dance

Control Group

ACTIVE COMPARATOR

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

Other: No intervention

Interventions

DanceOTHER

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).

Dance

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

Control Group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aline Nogueira Haas

Porto Alegre, Rio Grande do Sul, 90440-140, Brazil

Location

University of Wolverhampton, Walsall Campus

Walsall, West Midlands, WS1 3BD, United Kingdom

Location

Related 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.

    PMID: 28980176BACKGROUND
  • 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.

    PMID: 32811464BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Aline Nogueira Haas, PhD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 9, 2021

Study Start

December 10, 2018

Primary Completion

May 1, 2019

Study Completion

June 30, 2020

Last Updated

May 25, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations