Parkinson DiseaseNCT05973565
The Effects of a Single Session of Rhythmic Movement Program on Selected Biopsychological Parameters in PD Patients
A study testing Musicokinetic Training in people with Parkinson Disease and Rhythm, run by University of Wolverhampton at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Parkinson Disease, Rhythm
- What is being tested?
- Musicokinetic Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Dementia
- Deep brain stimulation,
- Cancer,
- Cardiovascular diseases
- Poor visual capability
- Poor or auditory capability
- Musculoskeletal problems
- No stable antiparkinsonian therapy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Wolverhampton
Walsall, West Midlands, WS1 3BD
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease, Rhythm
- Being tested
- Musicokinetic Training
- Keywords
- musicokinetic education, rhythm, dance, anxiety, gait, walking kinematics, walking kinetics, DLPFC hemodynamics
- Medical subject headings
- Parkinson Disease, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musicokinetic TrainingOther
The intervention protocols are either a) synchronous learning format, b) asynchronous remote video- based, and c) control.
| Study group | Role | What they receive |
|---|---|---|
| synchronous learning format | Experimental | 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. Receives: Other: Musicokinetic Training |
| Asynchronous remote video-based format | Experimental | 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 Receives: Other: Musicokinetic Training |
| Control | No intervention | Volunteers will not be asked to sit quietly for a 45-minute period |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 2 hours before the intervention arms and within 2 hours after the completion of the intervention arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study startOct 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wolverhampton
- Sponsor type
- University, hospital or other
- Collaborators
- University of Thessaly, National and Kapodistrian University of Athens, Federal University of Rio Grande do Sul, Karolinska Institutet
- Responsible party
- Principal investigator, Matthew Wyon, University of Wolverhampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973565
- Sponsor's protocol ID
- YKCK2019
- Status last verified
- Dec 2023
- First submitted
- 28 May 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Single Session of Rhythmic Movement Program on Selected Biopsychological Parameters in PD Patients: A Methodological Approach.
- ClinicalTrials.gov ID
- NCT05973565
- Acronym / sponsor ID
- YKCK2019
- Conditions
- Parkinson Disease, Rhythm
- Keywords
- musicokinetic education, rhythm, dance, anxiety, gait, walking kinematics, walking kinetics, DLPFC hemodynamics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- University of WolverhamptonUniversity, hospital or other
- Collaborators
- University of Thessaly, National and Kapodistrian University of Athens, Federal University of Rio Grande do Sul, Karolinska Institutet
- Study start
- Oct 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| synchronous learning format | Experimental | Other: Musicokinetic TrainingVolunteers 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. |
| Asynchronous remote video-based format | Experimental | Other: Musicokinetic TrainingVolunteers 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 |
| Control | No intervention | –Volunteers will not be asked to sit quietly for a 45-minute period |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Dementia
- Deep brain stimulation,
- Cancer,
- Cardiovascular diseases
- Poor visual capability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Musicokinetic TrainingThe intervention protocols are either a) synchronous learning format, b) asynchronous remote video- based, and c) control. | Other | Asynchronous remote video-based format, synchronous learning format |
Primary outcome
Anxiety
Time frame: 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.
Dorsolateral pre-frontal cortex (DLPFC) blood markers during gait
Time frame: 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.
Gait initiation - balance
Time frame: 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)
Gait initiation - acceleration
Time frame: 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 - stride length
Time frame: 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.
Walking kinematic parameters - shoulder-pelvis association
Time frame: 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
Time frame: 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.
Walking kinetic parameters - medio-lateral ground reaction forces
Time frame: 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)
Walking kinetic parameters- foot strike
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Musicokinetic Training in people with Parkinson Disease and Rhythm, run by University of Wolverhampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: 1-2 hours before the intervention arms and within 2 hours after the completion of the intervention arms). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023; AzTrials last refreshed its copy on 3 Nov 2026.