Parkinson DiseaseGAITPARKNCT06073028
Model-based Cueing-as-needed for Walking in Parkinson's Disease
A study testing 20-minute gait training in people with Parkinson Disease and Walking, Difficulty, run by Henri Mondor University Hospital at 1 site in France.
Trial summary
Correcting of the lack of regularity in steps is a key component of gait rehabilitation in Parkinson's disease. The proposal is to introduce adaptive spatial auditory cueing (ASAC) based on verbal instruction "lengthen the step" automatically delivered when the stride length decreased below a predetermined threshold. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Walking, Difficulty, Gait, Festinating
- What is being tested?
- 20-minute gait training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2021to 1 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the diagnosis of idiopathic PD based on the United Kingdom-Parkinson's Disease Society Brain Bank criteria;
- stage 2 or 3 on the Hoehn and Yahr scale;
- comfortable walking speed over 10 meters ≤ 1 m/s;
- ability to walk over 20 minutes without aids or antiparkinsonian medications;
- a stable antiparkinsonian medication regime;
- cognitive abilities to understand the verbal instructions for a walking test according to the investigator's judgment;
- written consent for the participation.
Who cannot join
- intercurrent disease other than PD, affecting gait;
- any intercurrent medical condition preventing them from participating in two consecutive gait training one week apart;
- medical diagnosis of hearing loss;
- non-affiliation to the social security regime.
Trial locations and contacts
1 site in 1 country.
About this study
Correcting of the lack of regularity in steps is a key component of gait rehabilitation in Parkinson's disease. The proposal is to introduce adaptive spatial auditory cueing (ASAC) based on verbal instruction "lengthen the step" automatically delivered when the stride length decreased below a predetermined threshold. The present study compared the effect of usual rhythmic auditory cueing versus ASAC used during a walking training in Parkinson's disease.
Read the detailed description
Correcting of the lack of regularity in steps is a key component of gait rehabilitation in Parkinson's disease. The proposal is to introduce adaptive spatial auditory cueing (ASAC) based on verbal instruction "lengthen the step" automatically delivered when the stride length decreased below a predetermined threshold. The present study compared the effect of usual rhythmic auditory cueing versus ASAC used during a walking training in Parkinson's disease. Fifteen patients with Parkinson's disease performed both interventions in randomized order, one week apart: a 20-minute walking training with rhythmic auditory cueing, in form of a metronome adjusted on 110% of the patient's own cadence, or ASAC delivered when the stride length is less than 110% of the patient's own stride length. Assessment criteria were walking distance covered during the intervention, speed, step length, cadence, coefficients of variation of step length and step duration, and indexes of spatial and temporal asymmetry during a walking test before and just after the intervention.
- Conditions
- Parkinson Disease, Walking, Difficulty, Gait, Festinating
- Being tested
- 20-minute gait training
- Keywords
- Basal Ganglia Diseases, Gait analysis, Gait Speed, Cues, Exercise Therapy
- Medical subject headings
- Parkinson Disease, Mobility Limitation, Gait Disorders, Neurologic, Basal Ganglia Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20-minute gait trainingOther
All subjects undergo two 20-minute gait trainings using two different kinds of auditory cueing (temporal or spatial), one week apart (D1 and D8).
| Study group | Role | What they receive |
|---|---|---|
| Rhythmic auditory cueing | Experimental | The rhythmic auditory cueing (RAC) is a constant stimulation ("bip" signal) delivered by a numeric metronome, which is adjusted on 110% of the patient's own cadence. Receives: Other: 20-minute gait training |
| Adaptive spatial auditory cueing | Experimental | Adaptive spatial auditory cueing (ASAC) is a verbal instruction stimulation delivered by an application when the stride length of the patient is less than a predetermined threshold, during two consecutive strides. The instruction is given in the patient's native language, which is French: "allongez le pas" (i.e. "lengthen the step"). The predetermined threshold is 110% of the patient's own stride length. Receives: Other: 20-minute gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed
Speed in free walking condition over 10 meters barefoot, without any assistance
Measured: Before and just after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Feb 2021
- Primary completion2 Feb 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Model description
- Pilot single-blind randomized cross-over study, with the subject blind as to the hypothesis
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 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
- Investigators
- Hutin Emilie, PhD, Principal investigator, HenriMondorHU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073028
- Sponsor's protocol ID
- GAITPARK
- Acronym
- GAITPARK
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 11 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 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model-based Cueing-as-needed for Walking in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06073028
- Acronym / sponsor ID
- GAITPARK / GAITPARK
- Conditions
- Parkinson Disease, Walking, Difficulty, Gait, Festinating
- Keywords
- Basal Ganglia Diseases, Gait analysis, Gait Speed, Cues, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Henri Mondor University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 10 Oct 2023 (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.
Correcting of the lack of regularity in steps is a key component of gait rehabilitation in Parkinson's disease. The proposal is to introduce adaptive spatial auditory cueing (ASAC) based on verbal instruction "lengthen the step" automatically delivered when the stride length decreased below a predetermined threshold. The present study compared the effect of usual rhythmic auditory cueing versus ASAC used during a walking training in Parkinson's disease.
Detailed description
Correcting of the lack of regularity in steps is a key component of gait rehabilitation in Parkinson's disease. The proposal is to introduce adaptive spatial auditory cueing (ASAC) based on verbal instruction "lengthen the step" automatically delivered when the stride length decreased below a predetermined threshold. The present study compared the effect of usual rhythmic auditory cueing versus ASAC used during a walking training in Parkinson's disease. Fifteen patients with Parkinson's disease performed both interventions in randomized order, one week apart: a 20-minute walking training with rhythmic auditory cueing, in form of a metronome adjusted on 110% of the patient's own cadence, or ASAC delivered when the stride length is less than 110% of the patient's own stride length. Assessment criteria were walking distance covered during the intervention, speed, step length, cadence, coefficients of variation of step length and step duration, and indexes of spatial and temporal asymmetry during a walking test before and just after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot single-blind randomized cross-over study, with the subject blind as to the hypothesis
| Arm | Type | Receives |
|---|---|---|
| Rhythmic auditory cueing | Experimental | Other: 20-minute gait trainingThe rhythmic auditory cueing (RAC) is a constant stimulation ("bip" signal) delivered by a numeric metronome, which is adjusted on 110% of the patient's own cadence. |
| Adaptive spatial auditory cueing | Experimental | Other: 20-minute gait trainingAdaptive spatial auditory cueing (ASAC) is a verbal instruction stimulation delivered by an application when the stride length of the patient is less than a predetermined threshold, during two consecutive strides. The instruction is given in the patient's native language, which is French: "allongez le pas" (i.e. "lengthen the step"). The predetermined threshold is 110% of the patient's own stride length. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- the diagnosis of idiopathic PD based on the United Kingdom-Parkinson's Disease Society Brain Bank criteria;
- stage 2 or 3 on the Hoehn and Yahr scale;
- comfortable walking speed over 10 meters ≤ 1 m/s;
- ability to walk over 20 minutes without aids or antiparkinsonian medications;
- a stable antiparkinsonian medication regime;
Key exclusion criteria (4 listed)
- intercurrent disease other than PD, affecting gait;
- any intercurrent medical condition preventing them from participating in two consecutive gait training one week apart;
- medical diagnosis of hearing loss;
- non-affiliation to the social security regime.
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 |
|---|---|---|
| 20-minute gait trainingAll subjects undergo two 20-minute gait trainings using two different kinds of auditory cueing (temporal or spatial), one week apart (D1 and D8). | Other | Adaptive spatial auditory cueing, Rhythmic auditory cueing |
Primary outcome
Walking speed
Time frame: Before and just after the intervention
Speed in free walking condition over 10 meters barefoot, without any assistance
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 11 Oct 2023.
- 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.
Hutin Emilie, PhD principal investigator
HenriMondorHU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20-minute gait training in people with Parkinson Disease and Walking, Difficulty, 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 7 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: finished, as of the sponsor's last update on 11 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?
Walking speed (time frame: Before and just after the intervention). 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 11 Oct 2023.