- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Sevilla
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Seville, Sevilla, Spanien, 41015
- Sevilla, España
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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%MIVC
Tidsramme: 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.
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Baseline (Day 1)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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CVM
Tidsramme: 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.
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Baseline (Day 1)
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Ratio (GM/TA)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Synukleinopatier
- Neurologiske manifestationer
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Neurodegenerative sygdomme
- Bevægelsesforstyrrelser
- Parkinsonlidelser
- Basal Ganglia Sygdomme
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Parkinsons sygdom
- Gangforstyrrelser, neurologiske
Andre undersøgelses-id-numre
- SICEIA-2025-000444
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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