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

Not Applicable

• Conditions: Locomotion Disorder, Neurologic; Rehabilitation; Parkinson Disease; Rhythm; Abnormal
• Interventions: Other: Stimulation with external auditory bio-feedback

• Registration Number: NCT04706572
• Lead Sponsor: I.R.C.C.S. Fondazione Santa Lucia

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.

Study Timeline

• Study First Submitted: 2019-10-08
• Study Start: 2020-06-15
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-09
• Study First Posted: 2021-01-13
• Last Update Submitted: 2021-01-17
• Last Update Posted: 2021-01-22
• Primary Completion: 2022-01
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Patients with Golden Rhythm	Stimulation with external auditory bio-feedback	Administration of an external auditory cue based on Golden Rhythm
Patients with Metronome	Stimulation with external auditory bio-feedback	Administration of an external auditory cue based on metronome binary rhythm

Primary Outcome Measures

Name	Time	Method
Efficacy of Golden Ratio-rhythm on Gait walking speed	18 months	Changes in walking speed between baseline and end of the study

Secondary Outcome Measures

Name	Time	Method
Efficacy of Golden Ratio-rhythm on stride to stance ratio	18 months	Changes in stride to stance ratio between baseline and end of the study and between more and less affected side
Efficacy of Golden Ratio-rhythm on stride lenght	18 months	Changes in stride length between baseline and end of the study and between more and less affected side
Efficacy of Golden Ratio-rhythm on hMaxMalleoli	18 months	Changes in maximum Malleoli heigth between baseline and end of the study and between more and less affected side
Efficacy of Golden Ratio-rhythm on toe clearance	18 months	Changes in toe clearance between baseline and end of the study and between more and less affected side

Trial Locations

Locations (1)

IRCCS Santa Lucia; 🇮🇹 Rome, Lazio, Italy