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

Not Applicable

Not yet recruiting

• Conditions: Rhythm; Parkinson Disease

• Registration Number: NCT05973565
• Lead Sponsor: University of Wolverhampton

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.

Study Timeline

• Study First Submitted: 2023-05-28
• Study First Submitted QC: 2023-07-31
• Study First Posted: 2023-08-03
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-15
• Study Start: 2024-10
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Gait initiation - balance	2 hours before the intervention arms and within 2 hours after the completion of the intervention arms	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)
Walking kinetic parameters - medio-lateral ground reaction forces	2 hours before the intervention arms and within 2 hours after the completion of the intervention arms	GRFs are calculated from both force plates, to evaluate the medio-lateral movement during the stance phase of walking (Fy+Fx)
Gait initiation - acceleration	2 hours before the intervention arms and within 2 hours after the completion of the intervention arms	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 - shoulder-pelvis association	2 hours before the intervention arms and within 2 hours after the completion of the intervention arms	Kinematic data obtained by the Vicon motion analysis system at 1000 Hz will focus on shoulder-pelvis association.
Walking kinematic parameters - gait velocity	2 hours before the intervention arms and within 2 hours after the completion of the intervention arms	Kinematic data obtained by the Vicon motion analysis system at 1000 Hz and will focus on gait velocity.
Anxiety	1-2 hours before the intervention arms and within 2 hours after the completion of the intervention arms	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.
Walking kinematic parameters - stride length	2 hours before the intervention arms and within 2 hours after the completion of the intervention arms	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.
Dorsolateral pre-frontal cortex (DLPFC) blood markers during gait	2 hours before the intervention arms and within 2 hours after the completion of the intervention arms	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.
Walking kinetic parameters- foot strike	2 hours before the intervention arms and within 2 hours after the completion of the intervention arms	GRFs are calculated from both force plates, to evaluate the strike forces during landing (Fz)

Trial Locations

Locations (1)

University of Wolverhampton; 🇬🇧 Walsall, West Midlands, United Kingdom