NCT04706572

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

1.5 years

First QC Date

October 8, 2019

Last Update Submit

January 17, 2021

Conditions

RehabilitationParkinson DiseaseLocomotion Disorder, NeurologicRhythm; Abnormal

Keywords

Golden rhythmAuditory cueParkinson's diseaseSmartphone AppGait analysis

Outcome Measures

Primary Outcomes (1)

  • Efficacy of Golden Ratio-rhythm on Gait walking speed

    Changes in walking speed between baseline and end of the study

    18 months

Secondary Outcomes (4)

  • Efficacy of Golden Ratio-rhythm on stride lenght

    18 months

  • Efficacy of Golden Ratio-rhythm on toe clearance

    18 months

  • Efficacy of Golden Ratio-rhythm on hMaxMalleoli

    18 months

  • Efficacy of Golden Ratio-rhythm on stride to stance ratio

    18 months

Study Arms (2)

Patients with Golden Rhythm

EXPERIMENTAL

Administration of an external auditory cue based on Golden Rhythm

Other: Stimulation with external auditory bio-feedback

Patients with Metronome

PLACEBO COMPARATOR

Administration of an external auditory cue based on metronome binary rhythm

Other: Stimulation with external auditory bio-feedback

Interventions

Stimulation with external auditory bio-feedbackOTHER

Administration of an external cue based on a personalized Golden Ratio -rhythm or a metronome-rhythm through an ad-hoc App for Smartphone

Patients with Golden RhythmPatients with Metronome

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Santa Lucia

Rome, Lazio, 00179, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseGait Disorders, NeurologicArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesPathologic Processes

Study Officials

  • Antonella Peppe

    Fondazione Santa Lucia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonella Peppe, MD

CONTACT

0039/0651501764a.peppe@hsantalucia.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2019

First Posted

January 13, 2021

Study Start

June 15, 2020

Primary Completion

January 1, 2022

Study Completion

June 1, 2022

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)