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

Primary Purpose

Parkinson Disease, Rhythm

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Musicokinetic Training
Sponsored by
University of Wolverhampton
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

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
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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
2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
Title
Gait initiation - balance
Description
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)
Time Frame
2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
Title
Gait initiation - acceleration
Description
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)
Time Frame
2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
Title
Walking kinematic parameters - stride length
Description
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.
Time Frame
2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
Title
Walking kinematic parameters - shoulder-pelvis association
Description
Kinematic data obtained by the Vicon motion analysis system at 1000 Hz will focus on shoulder-pelvis association.
Time Frame
2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
Title
Walking kinematic parameters - gait velocity
Description
Kinematic data obtained by the Vicon motion analysis system at 1000 Hz and will focus on gait velocity.
Time Frame
2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
Title
Walking kinetic parameters - medio-lateral ground reaction forces
Description
GRFs are calculated from both force plates, to evaluate the medio-lateral movement during the stance phase of walking (Fy+Fx)
Time Frame
2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
Title
Walking kinetic parameters- foot strike
Description
GRFs are calculated from both force plates, to evaluate the strike forces during landing (Fz)
Time Frame
2 hours before the intervention arms and within 2 hours after the completion of the intervention arms

10. Eligibility

Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Wolverhampton
City
Walsall
State/Province
West Midlands
ZIP/Postal Code
WS1 3BD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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