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| Name | Class |
|---|---|
| University of Roma La Sapienza | OTHER |
| Università degli studi di Roma Foro Italico | OTHER |
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Gait is specifically impaired in Parkinson's disease (PD). External auditory cue based on a binary rhythm tested in PD patients disappear when the stimulus is removed. Golden Ratio (GR)is intrinsic in the human gait, but in PD patients this GR has been found impaired. Aim of the study is the administration of an auditory external cue based on a personalized Golden Ratio-rhythm which could potentially assist people with PD to cope with the difficulties that they experience while walking, thus increasing their mobility and autonomy.
Gait is specifically impaired in Parkinson's disease (PD). External auditory cue based on a binary rhythm has been successfully used in people with PD to improve their gait quality, but the beneficial effects disappear when the stimulus is removed. Recent evidences have shown that, in healthy subjects, the structure of walking relies on a number, called Golden Ratio (GR), based on a perfect proportion between different gait phases. While GR is known to be impaired in people with PD, there are few evidences that a GR-based auditory stimulus could support people with PD in counteracting gait alterations. As hypothesis, an auditory external cue based on a personalized GR-rhythm could assist people with PD to cope with the difficulties that they experience while walking, thus increasing their mobility and autonomy, and that the nature of this GR-rhythm allows to maintain the beneficial effects in time. Two personalized auditory rhythms (a binary rhythm and a GR-rhythm) will be alternatively administered to each participant (see diagram below). Patient-specific rhythms will administered by a user-friendly ad-hoc app for smartphone. Two assessments will be performed during these 24 weeks, to assess treatment efficacy. At the end of the 24th week, half of patients will continue with the GR-rhythm and, in a final assessment, we will see if the effect lasts over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Golden Rhythm | Experimental | Administration of an external auditory cue based on Golden Rhythm |
|
| Patients with Metronome | Placebo Comparator | Administration of an external auditory cue based on metronome binary rhythm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stimulation with external auditory bio-feedback | Other | Administration of an external cue based on a personalized Golden Ratio -rhythm or a metronome-rhythm through an ad-hoc App for Smartphone |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Golden Ratio-rhythm on Gait walking speed | Changes in walking speed between baseline and end of the study | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Golden Ratio-rhythm on stride lenght | Changes in stride length between baseline and end of the study and between more and less affected side | 18 months |
| Efficacy of Golden Ratio-rhythm on toe clearance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonella Peppe, MD | Contact | 0039/0651501764 | a.peppe@hsantalucia.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonella Peppe | Fondazione Santa Lucia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Santa Lucia | Recruiting | Rome | Lazio | 00179 | Italy |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020233 | Gait Disorders, Neurologic |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Changes in toe clearance between baseline and end of the study and between more and less affected side
| 18 months |
| Efficacy of Golden Ratio-rhythm on hMaxMalleoli | Changes in maximum Malleoli heigth between baseline and end of the study and between more and less affected side | 18 months |
| Efficacy of Golden Ratio-rhythm on stride to stance ratio | Changes in stride to stance ratio between baseline and end of the study and between more and less affected side | 18 months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |