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

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Musicokinetic Training

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring musicokinetic education, rhythm, dance, anxiety, gait, walking kinematics, walking kinetics, DLPFC hemodynamics

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Wolverhampton

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

synchronous learning format

Asynchronous remote video-based format

Control

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Anxiety

Hamilton Anxiety rating scale. Scores of 17 or less indicates mild anxiety severity, 18 to 24 indicates mild to moderate anxiety severity, and 25 to 30 indicates a moderate to severe anxiety severity.

Dorsolateral pre-frontal cortex (DLPFC) blood markers during gait

A portable fNIRS system (Portalite, Artinis Medical Solutions, Netherlands) will be applied to monitor concentration changes (mM), of O2Hb, HHb and total hemoglobin (tHb) and the difference between O2Hb and HHb [Hbdiff = O2Hb -HHb] of the dorsal lateral prefrontal cortex (DLPFC). To correct for scattering of photons in the tissue, a differential path-length factor (DPF) of 4.0 will be used, for the calculation of absolute concentration changes at a sample frequency of 10Hz. The NIRS probe will be placed in the Brodmann 46 region on the right DLPFC, which has been proposed to be more involved in regulating muscle fatigue and activation. Subsequently, the NIRS probe will be fixed with adhesive tape and a dark elastic bandage around the head to avoid external light and artifacts. The O2Hb, HHb and tHb will be used as an indicator of DLPFC total activity, while the Hbdiff (i.e., oxygen supply vs demand) will be used as a marker of oxygenation in the DLPFC.

Gait initiation - balance

Using two force plates in line the participant stands on the first, adapting a quite bipedal stance and after a verbal command, starts ambulating forwarding one leg and stepping on the second plate. GRFs are calculated from both force plates, to evaluate the balance ability single leg stance (Fy+Fx)

Gait initiation - acceleration

Using two force plates in line the participant stands on the first, adapting a quite bipedal stance and after a verbal command, starts ambulating forwarding one leg and stepping on the second plate. GRFs are calculated from both force plates, to evaluate foot clear force (FZ) respectively (leg .1)

Walking kinematic parameters - stride length

Ground reaction force (GRF) data captured at 1000 Hz for the right and left leg by the force platforms will be synchronized with the kinematic data obtained by the Vicon motion analysis system at 1000 Hz. Kinematic data will focus on stride length and time and shoulder-pelvis association.

Walking kinematic parameters - shoulder-pelvis association

Kinematic data obtained by the Vicon motion analysis system at 1000 Hz will focus on shoulder-pelvis association.

Walking kinematic parameters - gait velocity

Kinematic data obtained by the Vicon motion analysis system at 1000 Hz and will focus on gait velocity.

Walking kinetic parameters - medio-lateral ground reaction forces

GRFs are calculated from both force plates, to evaluate the medio-lateral movement during the stance phase of walking (Fy+Fx)

Walking kinetic parameters- foot strike

GRFs are calculated from both force plates, to evaluate the strike forces during landing (Fz)

Secondary Outcome Measures

Full Information

NCT ID

NCT05973565

First Posted

May 28, 2023

Last Updated

July 31, 2023

Sponsor

University of Wolverhampton

Collaborators

University of Thessaly, National and Kapodistrian University of Athens, Federal University of Rio Grande do Sul, Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT05973565

Brief Title

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

Official Title

The Effects of a Single Session of Rhythmic Movement Program on Selected Biopsychological Parameters in PD Patients: A Methodological Approach.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 2023 (Anticipated)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Wolverhampton

Collaborators

University of Thessaly, National and Kapodistrian University of Athens, Federal University of Rio Grande do Sul, Karolinska Institutet

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 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease, Rhythm

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

Care ProviderOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

13 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

synchronous learning format

Arm Type

Experimental

Arm Description

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.

Arm Title

Asynchronous remote video-based format

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Musicokinetic Training

Intervention Description

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

Primary Outcome Measure Information:

Title

Anxiety

Description

Hamilton Anxiety rating scale. Scores of 17 or less indicates mild anxiety severity, 18 to 24 indicates mild to moderate anxiety severity, and 25 to 30 indicates a moderate to severe anxiety severity.

Time Frame

1-2 hours before the intervention arms and within 2 hours after the completion of the intervention arms

Title

Dorsolateral pre-frontal cortex (DLPFC) blood markers during gait

Description

A portable fNIRS system (Portalite, Artinis Medical Solutions, Netherlands) will be applied to monitor concentration changes (mM), of O2Hb, HHb and total hemoglobin (tHb) and the difference between O2Hb and HHb [Hbdiff = O2Hb -HHb] of the dorsal lateral prefrontal cortex (DLPFC). To correct for scattering of photons in the tissue, a differential path-length factor (DPF) of 4.0 will be used, for the calculation of absolute concentration changes at a sample frequency of 10Hz. The NIRS probe will be placed in the Brodmann 46 region on the right DLPFC, which has been proposed to be more involved in regulating muscle fatigue and activation. Subsequently, the NIRS probe will be fixed with adhesive tape and a dark elastic bandage around the head to avoid external light and artifacts. The O2Hb, HHb and tHb will be used as an indicator of DLPFC total activity, while the Hbdiff (i.e., oxygen supply vs demand) will be used as a marker of oxygenation in the DLPFC.

Time Frame