- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07584343
EMG of Gait Under Dual-Task in Parkinson Desease (EMG-DT-PD)
Electromyographic Activity of the Tibialis Anterior and Medial Gastrocnemius in Parkinson's Disease During Forward and Backward Gait Under Dual-Tasking: A Descriptive Study
In this observational study embedded within a randomized controlled trial, the investigators aim to characterize the activation patterns of the tibialis anterior and medial gastrocnemius muscles in the more rigid leg of patients with Parkinson's disease when performing walking tasks under dual cognitive-task conditions, which are known to increase the risk of falls in this population.
To this end, a control group without neurological disorders and with comparable sociodemographic characteristics will also be assessed.
The study seeks to determine whether significant changes occur in forward and backward gait as a function of the dual-task condition.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sevilla
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Seville, Sevilla, Spain, 41015
- Sevilla, España
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Ability to walk independently for at least 5 meters, both forward and backward, without the need for assistive devices or assistance from another person.
- Diagnosis of idiopathic Parkinson's disease made by a neurologist at Hospital Virgen Macarena.
- Hoehn and Yahr stage I-III.
- Being in the "ON" phase of antiparkinsonian medication during the assessment (approximately one hour after intake, when the pharmacokinetic curve of levodopa reaches its peak).
Exclusion Criteria:
- Presence of symptomatic musculoskeletal disorders affecting the lower limbs (LL) (relevant orthopedic surgery or leg length discrepancy > 1 cm), or other neurological conditions (stroke, neuropathies, etc.) that independently affect gait.
- Balance disorders due to other causes (vestibulopathy, severe orthostatic hypotension, etc.).
- Decompensated systemic diseases (cardiac disease, COPD, uncontrolled diabetes mellitus, etc.).
- Uncorrected visual impairments that may affect gait performance.
- Previous treatment with deep brain stimulation.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Parkinson Desease
Patients with Parkinson's disease recruited from the Parkinson's Association of Seville
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Healthy Subjects
Patients with similar sociodemographic characteristics without neurological disorders
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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%MIVC
Time Frame: Baseline (Day 1)
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It was calculated by expressing the Root Mean Square (RMS) value for each condition as a percentage of the Maximal Voluntary Contraction (MVC) obtained during the isometric test.
This approach ensures accurate quantification of neuromuscular effort, which is essential to minimize bias arising from anatomical and physiological differences between subjects.
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Baseline (Day 1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CVM
Time Frame: Baseline (Day 1)
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The Maximal Voluntary Contraction (MVC) was established as the reference value for neuromuscular activation capacity for each muscle (TA and GM).
This variable was obtained as the mean of three repetitions of maximal isometric activation lasting 6 seconds, allowing standardization of muscle responses to the dynamic efforts performed during gait.
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Baseline (Day 1)
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Ratio (GM/TA)
Time Frame: Baseline (Day 1)
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It is calculated as the ratio of activation between the agonist and antagonist muscles during the gait cycle.
This index is used to assess muscle co-activation strategies and the mechanical efficiency of gait.
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Baseline (Day 1)
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Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Synucleinopathies
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurodegenerative Diseases
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Parkinson Disease
- Gait Disorders, Neurologic
Other Study ID Numbers
- SICEIA-2025-000444
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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