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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05973565
• Other study ID #: YKCK2019
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2024
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: University of Wolverhampton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 13
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University of Wolverhampton	Walsall	West Midlands

Sponsors (5)

Lead Sponsor	Collaborator
University of Wolverhampton	Federal University of Rio Grande do Sul, Karolinska Institutet, National and Kapodistrian University of Athens, University of Thessaly

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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