Golden Walk as Measure of Gait Rehabilitation in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Golden Walk- A Wearable Technology Assessment and Biofeedback for Gait Rehabilitation in Parkinson's Disease Patients

Conditions
-----------------
Rehabilitation, Parkinson Disease, Locomotion Disorder, Neurologic, Rhythm; Abnormal

Intervention / Treatment
-----------------
* Other: Stimulation with external auditory bio-feedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of idiopathic PD, as proposed by the Brain Bank Criteria for PD, since at least 5 years suffered from a rigid akinetic form of bilateral Parkinson's Disease (Hoehn and Yahr: 2-3), according to current criteria to be on stable treatment regimen for at least the 3 months before the recruitment Mini Mental State Examination score >24 Do not vary the pharmacological treatment during the entire duration of the study Be tested in ON medication state Exclusion Criteria: inability to stand or walk without aids or supports factors affecting gait such as hip replacement, musculoskeletal disorders, uncorrected vision or vestibular problems; inability to follow instructions; severe dysautonomia with marked hypotension, major depression, dementia, pregnancy, or cardiac pacemaker

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Golden Rhythm<br>Administration of an external auditory cue based on Golden Rhythm | Other: Stimulation with external auditory bio-feedback<br>* Administration of an external cue based on a personalized Golden Ratio -rhythm or a metronome-rhythm through an ad-hoc App for Smartphone<br>|
| Placebo Comparator: Patients with Metronome<br>Administration of an external auditory cue based on metronome binary rhythm | Other: Stimulation with external auditory bio-feedback<br>* Administration of an external cue based on a personalized Golden Ratio -rhythm or a metronome-rhythm through an ad-hoc App for Smartphone<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Golden rhythm, Auditory cue, Parkinson's disease, Smartphone App, Gait analysis