Gait Disorders, NeurologicMUSIGAITNCT05585489
Individualization of Music-based Cueing During Gait in Parkinson's Disease.
A study testing Gait training with musical cue in people with Gait Disorders, Neurologic and Parkinson Disease, run by Henri Mondor University Hospital at 1 site in France.
Trial summary
Spatio-temporal correction of the step is a key component of gait rehabilitation in Parkinson's disease. Walking rehabilitation techniques using visual or auditory cueing of the cadence or step length have been tested to prevent or correct the lack of consistency of the step. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gait Disorders, Neurologic, Parkinson Disease
- What is being tested?
- Gait training with musical cue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2021to 30 Sep 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Idiopathic Parkinson's disease based on UKPDSBB criteria
- 10-meter walking comfortable speed between 0,30 and 1,10 m/s
- Capacities to walk with shoes during at least 20 minutes without assistance
- Signature of informed consent
Who cannot join
- Non-affiliation to Social Security
- Person under protection (e.g. under protection of justice)
- Auditory disorders without treatment
- Cognitive disorders that limit the understanding of the study according to the medical investigator
- Other neurological or orthoêdic disorders that addect walking
- Participating in another Category 1 or 2 interventional clinical study for the duration of the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individualization of Music-based Cueing During Gait in Parkinson's Disease. An Exploratory Cross-over Trial
Spatio-temporal correction of the step is a key component of gait rehabilitation in Parkinson's disease. Walking rehabilitation techniques using visual or auditory cueing of the cadence or step length have been tested to prevent or correct the lack of consistency of the step. An auditory cue of the duration of the step, encouraging it to be extended according to patient own capacities during gait has been proposed. The cue is integrated into music and is presented in an open-loop approach.
The present study aimed to evaluate the effect of the individual music-based cueing of the step length on gait in Parkinson's disease.
- Conditions
- Gait Disorders, Neurologic, Parkinson Disease
- Being tested
- Gait training with musical cue
- Medical subject headings
- Gait Disorders, Neurologic, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait training with musical cueOther
Entraînement de 20 minutes de marche à vitesse confortable sur un parcours ovale de 20 mètres au laboratoire ARM avec la technique d'indiçage musical personnalisé de la longueur de pas.
| Study group | Role | What they receive |
|---|---|---|
| Persons with moderate idiopathic Parkinson's disease | Experimental | Not described Receives: Other: Gait training with musical cue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step length
Step length during confortable gait over 8 meters
Measured: Before and just after the intervention (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start22 Jun 2021
- Primary completion6 Jul 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Disorders, NeurologicStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henri Mondor University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilie Hutin, Henri Mondor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585489
- Sponsor's protocol ID
- 2021-A00959-32
- Acronym
- MUSIGAIT
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2022
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- 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 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualization of Music-based Cueing During Gait in Parkinson's Disease. An Exploratory Cross-over Trial
- ClinicalTrials.gov ID
- NCT05585489
- Acronym / sponsor ID
- MUSIGAIT / 2021-A00959-32
- Conditions
- Gait Disorders, Neurologic, Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Henri Mondor University HospitalUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 6 Jul 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 18 Oct 2022 (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.
Spatio-temporal correction of the step is a key component of gait rehabilitation in Parkinson's disease. Walking rehabilitation techniques using visual or auditory cueing of the cadence or step length have been tested to prevent or correct the lack of consistency of the step. An auditory cue of the duration of the step, encouraging it to be extended according to patient own capacities during gait has been proposed. The cue is integrated into music and is presented in an open-loop approach.
The present study aimed to evaluate the effect of the individual music-based cueing of the step length on gait in Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons with moderate idiopathic Parkinson's disease | Experimental | Other: Gait training with musical cue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Idiopathic Parkinson's disease based on UKPDSBB criteria
- 10-meter walking comfortable speed between 0,30 and 1,10 m/s
- Capacities to walk with shoes during at least 20 minutes without assistance
- Signature of informed consent
Key exclusion criteria (6 listed)
- Non-affiliation to Social Security
- Person under protection (e.g. under protection of justice)
- Auditory disorders without treatment
- Cognitive disorders that limit the understanding of the study according to the medical investigator
- Other neurological or orthoêdic disorders that addect walking
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 |
|---|---|---|
| Gait training with musical cueEntraînement de 20 minutes de marche à vitesse confortable sur un parcours ovale de 20 mètres au laboratoire ARM avec la technique d'indiçage musical personnalisé de la longueur de pas. | Other | Persons with moderate idiopathic Parkinson's disease |
Primary outcome
Step length
Time frame: Before and just after the intervention (day 1)
Step length during confortable gait over 8 meters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Gait Disorders, Neurologic
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Virtual Reality Versus Mental Practice On Balance And Gait In Patients With Multiple Sclerosis
Multiple Sclerosis
Active, not recruiting
Flexibility, Resistance, Aerobic, Movement Execution Training in Adults With Hereditary Spastic Paraplegia
Hereditary Spastic Paraplegia
Recruiting
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Stroke, Hemiplegia
Not yet recruiting
Effects of Jaw Clenching on Gait and Mobility in Stroke
Stroke
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait training with musical cue in people with Gait Disorders, Neurologic and Parkinson Disease, run by Henri Mondor University Hospital at 1 site in France.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 4 Oct 2023. 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 France. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step length (time frame: Before and just after the intervention (day 1)). 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 4 Oct 2023.