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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06230718
Other study ID # MIAO
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date January 30, 2025

Study information

Verified date January 2024
Source University of Salamanca
Contact Beatriz María Bermejo Gil, Dr
Phone 622289468
Email beatriz.bermejo@usal.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study focuses on electromyographic analysis of upper limb muscle activation in stroke survivors during Motor Imagery (MI) and Action Observation (AO) rehabilitation techniques. By measuring muscle activity in the wrist and finger flexors and extensors, the research seeks to understand the impact of MI and AO on motor function recovery post-stroke. Conducted at the University of Salamanca, the study involves stroke survivors participating in a series of three experimental sessions. The analysis will correlate electromyographic responses with functional independence, limb functionality, and cognitive factors. The research aims to contribute to the fields of occupational therapy and physiotherapy, offering insights into effective rehabilitation methods for improving quality of life in stroke survivors.


Description:

This study investigates muscle activation in the upper limbs of stroke survivors using electromyographic analysis during Motor Imagery (MI) and Action Observation (AO). Stroke, a major cause of disability, often results in motor impairments in the upper limb, impacting daily activities. The research focuses on innovative rehabilitation techniques based on neuroplasticity, such as MI and AO, stimulated by the discovery of mirror neurons. The primary goal is to record upper limb muscle activation during MI and AO, using surface electromyography to measure activation in wrist and finger flexors and extensors. The study will also explore the relationship between electromyographic responses and factors like daily activity independence, limb functionality, quality of life, mental evocation ability, and cognitive impairment. Conducted at the University of Salamanca, the study will recruit stroke survivors for a three-session experimental protocol involving control, MI, and AO conditions. Data will be analyzed with SPSS Statistics, ensuring anonymity and ethical compliance. The research aims to enhance understanding of effective neurorehabilitation techniques, contributing to the fields of occupational therapy and physiotherapy.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date January 30, 2025
Est. primary completion date January 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Being over 18 years of age - Diagnoses of established stroke - Present limitations or motor response deficiencies in the upper limb - Maintain cognitive functions with the ability to follow the instructions of the interventions and evaluations (MOCA>14) Exclusion Criteria: - Diagnosed with mental illness before the stroke - Other systemic conditions on the central nervous system - Cardiorespiratory system pathologies in severe cases - Acute period, fever, muscle inflammation or myopathies - Any type of vascular and organic insufficiency - Liver disease or skin lesions in the area of application of the electrodes.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Motor Imagery (MI)
mental process where an individual visualizes or imagines themselves performing a movement without actually executing it physically. This cognitive process involves the mental rehearsal of motor actions, engaging similar neural pathways that are used when physically performing the action.
Action Observation (AO)
rehabilitation technique based on the principle of observing actions to improve motor function and learning. This approach is rooted in the concept of the mirror neuron system, a group of neurons that are activated both when a person performs an action and when they observe the same action performed by others.
Control condition- placebo
Recording with images of landscapes without the presence of any person or animal that could evoke MI or OA.

Locations

Country Name City State
Spain Universidad de Salmanca Salamanca

Sponsors (1)

Lead Sponsor Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disability and Dependence Level - Barthel Index A general measure assessing patient independence, evaluating performance in basic daily activities (ADLs). Administered once, typically taking a few minutes.
Primary Upper Limb Functionality - Action Research Arm Test (ARAT) Assesses upper limb functionality post-cortical injury, involving manipulation tasks with various objects. Administration time ranges from 5 to 15 minutes.
Primary Cognitive Impairment - Montreal Cognitive Assessment (MoCA) Evaluates mild cognitive dysfunctions across multiple domains, including attention, memory, language, and executive functions. takes about 10 minutes for administration.
Primary Perception Impairment - Loewenstein Occupational Therapy Cognitive Assessment (LOTCA) Specific for occupational therapy in stroke patients, assessing visual, spatial, motor, and cognitive perception. Duration varies based on the number and type of subtests administered.
Primary Mental Evocation Ability - Mental Evocation of Images, Movements, and Activities Questionnaire (CEMIMA) Measures the ability to mentally form visual and kinesthetic images of the hand/upper limb. Duration varies
Primary Quality of Life Perception - Stroke Impact Scale 16 (SIS-16) A self-report measure focusing on physical aspects including strength, hand function, mobility, and ADLs. 5-10 minutes.
Primary Electromyographic Activity During MI and AO muscle activity using surface electrodes on wrist extensors and flexors. during the experimental setup
Secondary Age birth age 1 minute
Secondary gender he gender with which the participant identifies 1 minute
Secondary Marital Status single, married, divorced 1 minute
Secondary Education Level he highest level of education 1 minute
Secondary Economic Status participant's economic 1 minute
Secondary Affected Side The side of the body affected by the stroke or injury 1 minute
Secondary Dominant Side The side of the body that is the participant's natural dominant side 1 minute
Secondary Type of Lesion specific type of brain injury 1 minute
Secondary Time Since Injury time since the participant had the brain injury or stroke. 1 minute
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