Clinical trial NCT05973565: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Rhythm
Keywords: musicokinetic education
rhythm
dance
anxiety
gait
walking kinematics
walking kinetics
DLPFC hemodynamics
Lead sponsor: University of Wolverhampton
Sponsor class: OTHER
Collaborators: name: University of Thessaly
name: National and Kapodistrian University of Athens
name: Federal University of Rio Grande do Sul
name: Karolinska Institutet
First posted: 2023-08-03
Enrollment: 13
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Anxiety
timeFrame: 1-2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
measure: Dorsolateral pre-frontal cortex (DLPFC) blood markers during gait
timeFrame: 2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
measure: Gait initiation - balance
timeFrame: 2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
measure: Gait initiation - acceleration
timeFrame: 2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
measure: Walking kinematic parameters - stride length
timeFrame: 2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
measure: Walking kinematic parameters - shoulder-pelvis association
timeFrame: 2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
measure: Walking kinematic parameters - gait velocity
timeFrame: 2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
measure: Walking kinetic parameters - medio-lateral ground reaction forces
timeFrame: 2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
measure: Walking kinetic parameters- foot strike
timeFrame: 2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
Secondary outcomes:
Other outcomes:
Locations:
city: Walsall
country: United Kingdom
facility: University of Wolverhampton
state: West Midlands
Study officials:
References: