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

Primary Purpose

Rehabilitation, Parkinson Disease, Locomotion Disorder, Neurologic

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Stimulation with external auditory bio-feedback
Sponsored by
I.R.C.C.S. Fondazione Santa Lucia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rehabilitation focused on measuring Golden rhythm, Auditory cue, Parkinson's disease, Smartphone App, Gait analysis

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IRCCS Santa LuciaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Patients with Golden Rhythm

Patients with Metronome

Arm Description

Administration of an external auditory cue based on Golden Rhythm

Administration of an external auditory cue based on metronome binary rhythm

Outcomes

Primary Outcome Measures

Efficacy of Golden Ratio-rhythm on Gait walking speed
Changes in walking speed between baseline and end of the study

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
October 8, 2019
Last Updated
January 17, 2021
Sponsor
I.R.C.C.S. Fondazione Santa Lucia
Collaborators
University of Roma La Sapienza, Università degli studi di Roma Foro Italico
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1. Study Identification

Unique Protocol Identification Number
NCT04706572
Brief Title
Golden Walk as Measure of Gait Rehabilitation in Parkinson's Disease
Official Title
Golden Walk- A Wearable Technology Assessment and Biofeedback for Gait Rehabilitation in Parkinson's Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.R.C.C.S. Fondazione Santa Lucia
Collaborators
University of Roma La Sapienza, Università degli studi di Roma Foro Italico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rehabilitation, Parkinson Disease, Locomotion Disorder, Neurologic, Rhythm; Abnormal
Keywords
Golden rhythm, Auditory cue, Parkinson's disease, Smartphone App, Gait analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with Golden Rhythm
Arm Type
Experimental
Arm Description
Administration of an external auditory cue based on Golden Rhythm
Arm Title
Patients with Metronome
Arm Type
Placebo Comparator
Arm Description
Administration of an external auditory cue based on metronome binary rhythm
Intervention Type
Other
Intervention Name(s)
Stimulation with external auditory bio-feedback
Intervention Description
Administration of an external cue based on a personalized Golden Ratio -rhythm or a metronome-rhythm through an ad-hoc App for Smartphone
Primary Outcome Measure Information:
Title
Efficacy of Golden Ratio-rhythm on Gait walking speed
Description
Changes in walking speed between baseline and end of the study
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Efficacy of Golden Ratio-rhythm on stride lenght
Description
Changes in stride length between baseline and end of the study and between more and less affected side
Time Frame
18 months
Title
Efficacy of Golden Ratio-rhythm on toe clearance
Description
Changes in toe clearance between baseline and end of the study and between more and less affected side
Time Frame
18 months
Title
Efficacy of Golden Ratio-rhythm on hMaxMalleoli
Description
Changes in maximum Malleoli heigth between baseline and end of the study and between more and less affected side
Time Frame
18 months
Title
Efficacy of Golden Ratio-rhythm on stride to stance ratio
Description
Changes in stride to stance ratio between baseline and end of the study and between more and less affected side
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonella Peppe, MD
Phone
0039/0651501764
Email
a.peppe@hsantalucia.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonella Peppe
Organizational Affiliation
Fondazione Santa Lucia
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Santa Lucia
City
Rome
State/Province
Lazio
ZIP/Postal Code
00179
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonella Peppe, MD, PhD
Phone
+3951501765
Email
a.peppe@hsantalucia.it
First Name & Middle Initial & Last Name & Degree
Marco Iosa, PhD
Phone
+393332150104
Email
m.iosa@hsantalucia.it
First Name & Middle Initial & Last Name & Degree
Antonella Peppe, MD, PhD
First Name & Middle Initial & Last Name & Degree
Marco Iosa, PhD
First Name & Middle Initial & Last Name & Degree
Giuseppe Vannozzi, PhD
First Name & Middle Initial & Last Name & Degree
Valeria Belluscio, Ms

12. IPD Sharing Statement

Plan to Share IPD
No

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

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