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

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

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease; Rehabilitation; Locomotion Disorder, Neurologic; Rhythm; Abnormal
• Intervention / Treatment: Other: Stimulation with external auditory bio-feedback

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonella Peppe, MD; Phone Number: 0039/0651501764; Email: a.peppe@hsantalucia.it

Study Locations

• Italy
  • Lazio
    • Rome, Lazio, Italy, 00179
      • Recruiting
      • IRCCS Santa Lucia
      • Contact: Antonella Peppe, MD, PhD; Phone Number: +3951501765; Email: a.peppe@hsantalucia.it
      • Contact: Marco Iosa, PhD; Phone Number: +393332150104; Email: m.iosa@hsantalucia.it
      • Principal Investigator: Antonella Peppe, MD, PhD
      • Sub-Investigator: Marco Iosa, PhD
      • Sub-Investigator: Giuseppe Vannozzi, PhD
      • Sub-Investigator: Valeria Belluscio, Ms

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: I.R.C.C.S. Fondazione Santa Lucia
• Collaborators: University of Roma La Sapienza; Università degli studi di Roma Foro Italico
• Investigators: Principal Investigator: Antonella Peppe, Fondazione Santa Lucia

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: January 9, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 17, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Parkinson's disease; Gait analysis; Smartphone App; Golden rhythm; Auditory cue
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Nervous System Diseases; Arrhythmias, Cardiac; Gait Disorders, Neurologic
• Other Study ID Numbers: HSantaLucia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No