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The Effects of a Single Session of Rhythmic Movement Program on Selected Biopsychological Parameters in PD Patients

NCT ID: NCT05973565

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2024-12-31

Brief Summary

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The aim of the present study is to examine the acute effects of a specially designed musicokinetic (MSK) program for patients with Parkinson's disease (PD) on a) anxiety levels b) select kinematic and kinetic parameters, and c) frontal cortex hemodynamic responses, during gait initiation and steady-state walking.

Detailed Description

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This is a blind cross over randomized control trial (RCT) in which 13 volunteers with PD will attend a 45 min MSK program under the following conditions: a) synchronous learning format, b) asynchronous remote video- based, and c) control conditions. Changes in gait biomechanics and frontal cortex hemodynamic responses will be examined using a 10-camera 3D motion analysis (Vicon T-series, Oxford, UK), and a functional near-infrared spectroscopy (f-NIRS - Portalite, Artinis, NL) system, respectively, while anxiety levels will be evaluated using the Hamilton Anxiety Rating Scale.

Conditions

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Parkinson Disease Rhythm

Keywords

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musicokinetic education rhythm dance anxiety gait walking kinematics walking kinetics DLPFC hemodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Volunteers will be asked to attend three conditions in a randomized order, separated by at least a week of washing out period. Levels of anxiety, kinematic, and DLPFC hemodynamic activity data will be collected before and after the two different interventions, while, on a third occasion, control data will be collected at the same time-points but without any intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
Participants will be randomly (randomizer.org) assigned by a researcher blinded to the study either to start with the synchronous intervention or with the asynchronous remote video-based intervention. Two evaluators also blinded to the scope of the study will take all measurements before and after interventions. It will be not possible to blind participants as the delivery of the class will reveal their allocation

Study Groups

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synchronous learning format

Volunteers will be asked to attend synchronous learning format MSK Training. The exercise protocol has a duration of 45 minutes of rhythmic training and includes sections of warming-up, stretching, breathing, movement combinations, a dance sequence and recovery. Each exercise is accompanied with music that provides a clear and predictable rhythm. More specifically, the beat or rhythm of the music is used as a guide for the timing and duration of specific movements, allowing people with PD to coordinate their movements with the music. Simple values are going to be introduced such as whole notes, half notes and quarter notes; clapping and tapping, breathing and sounds. Class will be accompanied by recorded classical piano music, to meet the needs of synchronous learning format and asynchronous remote video-based format. The intensity of the class is moderate approximately 3 MET. The instructor is an experienced dance teacher in musicokinetic education.

Group Type EXPERIMENTAL

Musicokinetic Training

Intervention Type OTHER

The intervention protocols are either a) synchronous learning format, b) asynchronous remote video- based, and c) control.

Asynchronous remote video-based format

Volunteers will be asked to attend asynchronous remote video-based format MSK Training.

The exercise protocol is the same as the synchronous format but delivered via a video-based format

Group Type EXPERIMENTAL

Musicokinetic Training

Intervention Type OTHER

The intervention protocols are either a) synchronous learning format, b) asynchronous remote video- based, and c) control.

Control

Volunteers will not be asked to sit quietly for a 45-minute period

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Musicokinetic Training

The intervention protocols are either a) synchronous learning format, b) asynchronous remote video- based, and c) control.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Hoehn and Yahr (H\&Y) Parkinson disease scale I-III
* No restriction on disease duration,
* No restriction on type of drug therapy
* Stable antiparkinsonian medication of at least 6 months
* Data collections will be "on" medication
* No participation to any other exercise program for at least 2 months
* 100% attendance of the session.

Exclusion Criteria

* Dementia
* Deep brain stimulation,
* Cancer,
* Cardiovascular diseases
* Poor visual capability
* Poor or auditory capability
* Musculoskeletal problems
* No stable antiparkinsonian therapy
Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Thessaly

OTHER

Sponsor Role collaborator

National and Kapodistrian University of Athens

OTHER

Sponsor Role collaborator

Federal University of Rio Grande do Sul

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

University of Wolverhampton

OTHER

Sponsor Role lead

Responsible Party

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Matthew Wyon

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Wolverhampton

Walsall, West Midlands, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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YKCK2019

Identifier Type: -

Identifier Source: org_study_id