RehabilitationNCT04706572
Golden Walk as Measure of Gait Rehabilitation in Parkinson's Disease
A study testing Stimulation with external auditory bio-feedback in people with Rehabilitation and Parkinson Disease, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Rehabilitation, Parkinson Disease, Locomotion Disorder, Neurologic
- What is being tested?
- Stimulation with external auditory bio-feedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2020to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Santa Lucia
Rome, Lazio, 00179
Antonella Peppe, MD, PhD, +3951501765, a.peppe@hsantalucia.it
Marco Iosa, PhD, +393332150104, m.iosa@hsantalucia.it
About this study
Official title: 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.
Read the 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.
- Being tested
- Stimulation with external auditory bio-feedback
- Keywords
- Golden rhythm, Auditory cue, Parkinson's disease, Smartphone App, Gait analysis
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with Golden Rhythm | Experimental | Administration of an external auditory cue based on Golden Rhythm Receives: Other: Stimulation with external auditory bio-feedback |
| Patients with Metronome | Placebo comparator | Administration of an external auditory cue based on metronome binary rhythm Receives: Other: Stimulation with external auditory bio-feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Golden Ratio-rhythm on Gait walking speed
Changes in walking speed between baseline and end of the study
Measured: 18 months
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start15 Jun 2020
- Primary completionJan 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza, Università degli studi di Roma Foro Italico
- Responsible party
- Principal investigator, Antonella Peppe, I.R.C.C.S. Fondazione Santa Lucia
- Investigators
- Antonella Peppe, Principal investigator, Fondazione Santa Lucia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706572
- Sponsor's protocol ID
- HSantaLucia
- Status last verified
- Jan 2021
- First submitted
- 8 Oct 2019
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Golden Walk- A Wearable Technology Assessment and Biofeedback for Gait Rehabilitation in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT04706572
- Acronym / sponsor ID
- HSantaLucia
- Keywords
- Golden rhythm, Auditory cue, Parkinson's disease, Smartphone App, Gait analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza, Università degli studi di Roma Foro Italico
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Golden Rhythm | Experimental | Other: Stimulation with external auditory bio-feedbackAdministration of an external auditory cue based on Golden Rhythm |
| Patients with Metronome | Placebo comparator | Other: Stimulation with external auditory bio-feedbackAdministration of an external auditory cue based on metronome binary rhythm |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stimulation with external auditory bio-feedbackAdministration of an external cue based on a personalized Golden Ratio -rhythm or a metronome-rhythm through an ad-hoc App for Smartphone | Other | Patients with Golden Rhythm, Patients with Metronome |
Primary outcome
Efficacy of Golden Ratio-rhythm on Gait walking speed
Time frame: 18 months
Changes in walking speed between baseline and end of the study
4 secondary outcomes
Efficacy of Golden Ratio-rhythm on stride lenght
Time frame: 18 months
Efficacy of Golden Ratio-rhythm on toe clearance
Time frame: 18 months
Efficacy of Golden Ratio-rhythm on hMaxMalleoli
Time frame: 18 months
Efficacy of Golden Ratio-rhythm on stride to stance ratio
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonella Peppe principal investigator
Fondazione Santa Lucia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulation with external auditory bio-feedback in people with Rehabilitation and Parkinson Disease, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonella Peppe, MD (0039/0651501764, a.peppe@hsantalucia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Golden Ratio-rhythm on Gait walking speed (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.