Parkinson Disease (PD)EMG-DT-PDNCT07584343
EMG of Gait Under Dual-Task in Parkinson Desease
An observational study of Parkinson Disease (PD) and Electromyography, run by University of Cadiz at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease (PD), Electromyography, Dual Task Walking
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2026to 30 Mar 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Parkinson's disease and mild cognitive and gait functional impairment recruited from the Parkinson's Association of Seville.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Parkinson Disease (PD), Electromyography, Dual Task Walking
- Keywords
- Parkinson Disease, Gait Disorders, Neurologic, Dual-Task Tests, Muscle Contraction, Wearable Electronic Devices
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson Desease | Patients with Parkinson's disease recruited from the Parkinson's Association of Seville | |
| Healthy Subjects | Patients with similar sociodemographic characteristics without neurological disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
%MIVC
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.
Measured: Baseline (Day 1)
Secondary outcomes (2)
CVM
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.
Measured: Baseline (Day 1)
Ratio (GM/TA)
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.
Measured: Baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start15 Mar 2026
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Virgen Macarena, Facultad de Enfermería, Fisioterapia y Podología (FEFP), Asociación de Enfermos de Parkinson de Sevilla
- Responsible party
- Principal investigator, Antonio Gil Centeno, University of Cadiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584343
- Sponsor's protocol ID
- SICEIA-2025-000444
- Acronym
- EMG-DT-PD
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 13 May 2026
- 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyographic Activity of the Tibialis Anterior and Medial Gastrocnemius in Parkinson's Disease During Forward and Backward Gait Under Dual-Tasking: A Descriptive Study
- ClinicalTrials.gov ID
- NCT07584343
- Acronym / sponsor ID
- EMG-DT-PD / SICEIA-2025-000444
- Conditions
- Parkinson Disease (PD), Electromyography, Dual Task Walking
- Keywords
- Parkinson Disease, Gait Disorders, Neurologic, Dual-Task Tests, Muscle Contraction, Wearable Electronic Devices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Collaborators
- Hospital Universitario Virgen Macarena, Facultad de Enfermería, Fisioterapia y Podología (FEFP), Asociación de Enfermos de Parkinson de Sevilla
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 13 May 2026 (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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson Desease | – | –Patients with Parkinson's disease recruited from the Parkinson's Association of Seville |
| Healthy Subjects | – | –Patients with similar sociodemographic characteristics without neurological disorders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease and mild cognitive and gait functional impairment recruited from the Parkinson's Association of Seville.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
%MIVC
Time frame: Baseline (Day 1)
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.
2 secondary outcomes
CVM
Time frame: Baseline (Day 1)
Ratio (GM/TA)
Time frame: Baseline (Day 1)
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 13 May 2026.
- m-Durance official websiteLink provided by the sponsor.
- 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.
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?
An observational study of Parkinson Disease (PD) and Electromyography, run by University of Cadiz at 1 site in Spain.
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 4 inclusion and 5 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 13 May 2026. 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 Spain. 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?
%MIVC (time frame: Baseline (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 13 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.