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Completed

NCT Number: NCT07584343

EMG of Gait Under Dual-Task in Parkinson Desease

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.

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Key information

Conditions

Parkinson Disease (PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dual Task Walking Electromyography Gait Disorders, Neurologic Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sevilla, España

Seville, Sevilla, 41015, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. %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.

Secondary outcomes

  1. CVM

    Time frame: Baseline (Day 1)

    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.

  2. Ratio (GM/TA)

    Time frame: Baseline (Day 1)

    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.

Sponsors and collaborators

Lead sponsor

University of Cadiz

Other

Collaborators

  • Asociación de Enfermos de Parkinson de Sevilla
  • Facultad de Enfermería, Fisioterapia y Podología (FEFP)
  • Hospital Universitario Virgen Macarena

Registry information

Official study 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

Acronym: EMG-DT-PD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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