Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04706572
Status:
UNKNOWN
Last Update Posted:
2021-01-22
First Post:
2019-10-08
Brief Title:
Golden Walk as Measure of Gait Rehabilitation in Parkinsons Disease
Sponsor:
IRCCS Fondazione Santa Lucia
Organization:
IRCCS Fondazione Santa Lucia
Study Overview
Official Title:
Golden Walk- A Wearable Technology Assessment and Biofeedback for Gait Rehabilitation in Parkinsons Disease Patients
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gait is specifically impaired in Parkinsons disease PD External auditory cue based on a binary rhythm tested in PD patients disappear when the stimulus is removed Golden Ratio GRis 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 Parkinsons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None