EMG of Gait Under Dual-Task in Parkinson Desease

NCT07584343 | Completed

• 1 other identifier: SICEIA-2025-000444
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• %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.

  Baseline (Day 1)

Secondary Outcomes (2)

• CVM

  Baseline (Day 1)

• Ratio (GM/TA)

  Baseline (Day 1)

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson's disease and mild cognitive and gait functional impairment recruited from the Parkinson's Association of Seville.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cadiz: lead
• Hospital Universitario Virgen Macarena: collaborator
• Facultad de Enfermería, Fisioterapia y Podología (FEFP): collaborator
• Asociación de Enfermos de Parkinson de Sevilla: collaborator

Study Sites (1)

Sevilla, España

Seville, Sevilla, 41015, Spain

Location

Related Links

• m-Durance official website

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 13, 2026
• Study Start: March 15, 2026
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)