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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson Disease; Rhythm
• Intervention / Treatment: Other: Musicokinetic Training

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.

• Study Type: Interventional
• Enrollment (Estimated): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Walsall, West Midlands, United Kingdom, WS1 3BD
      • University of Wolverhampton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Musicokinetic Training; The intervention protocols are either a) synchronous learning format, b) asynchronous remote video- based, and c) control.
Experimental: 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	Other: Musicokinetic Training; The intervention protocols are either a) synchronous learning format, b) asynchronous remote video- based, and c) control.
No Intervention: Control; Volunteers will not be asked to sit quietly for a 45-minute period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
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.	2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
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)	2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
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)	2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
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.	2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
Walking kinematic parameters - shoulder-pelvis association	Kinematic data obtained by the Vicon motion analysis system at 1000 Hz will focus on shoulder-pelvis association.	2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
Walking kinematic parameters - gait velocity	Kinematic data obtained by the Vicon motion analysis system at 1000 Hz and will focus on gait velocity.	2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
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)	2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
Walking kinetic parameters- foot strike	GRFs are calculated from both force plates, to evaluate the strike forces during landing (Fz)	2 hours before the intervention arms and within 2 hours after the completion of the intervention arms

Collaborators and Investigators

• Sponsor: University of Wolverhampton
• Collaborators: Karolinska Institutet; Federal University of Rio Grande do Sul; National and Kapodistrian University of Athens; University of Thessaly

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 28, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: gait; anxiety; dance; rhythm; musicokinetic education; walking kinematics; walking kinetics; DLPFC hemodynamics
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: YKCK2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No