- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06230718
EMG Analysis in ABI: Motor Imagery and Action
Upper Limb Electromyographic Response to Motor Imagery and Action Observation in Acquired Brain Injury Patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Beatriz María Bermejo Gil, Dr
- Phone Number: 622289468
- Email: beatriz.bermejo@usal.es
Study Contact Backup
- Name: Ana MAría Martín Nogueras, Dr
- Phone Number: 677510296
- Email: anamar@usal.es
Study Locations
-
-
Salamanca
-
Salamanca, Salamanca, Spain, 37007
- Recruiting
- Universidad de Salmanca
-
Contact:
- Beatriz María Bermejo Gil, Dr.
- Phone Number: 622289468
- Email: beatriz.bermejo@usal.es
-
Principal Investigator:
- Beatriz María Bermejo Gil, Dr
-
Contact:
- Ana María Martín Nogueras
- Phone Number: 677510296
- Email: anamar@usal.es
-
Principal Investigator:
- Sara Santiago Marín, Phd Student
-
Principal Investigator:
- AnaBelen Calvo Vera, Dr
-
Principal Investigator:
- Ana María Martín Nogueras, Dr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
The intervention group will receive 3 experimental procedures
|
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.
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.
Recording with images of landscapes without the presence of any person or animal that could evoke MI or OA.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disability and Dependence Level - Barthel Index
Time Frame: Administered once, typically taking a few minutes.
|
A general measure assessing patient independence, evaluating performance in basic daily activities (ADLs).
|
Administered once, typically taking a few minutes.
|
|
Upper Limb Functionality - Action Research Arm Test (ARAT)
Time Frame: Administration time ranges from 5 to 15 minutes.
|
Assesses upper limb functionality post-cortical injury, involving manipulation tasks with various objects.
|
Administration time ranges from 5 to 15 minutes.
|
|
Cognitive Impairment - Montreal Cognitive Assessment (MoCA)
Time Frame: takes about 10 minutes for administration.
|
Evaluates mild cognitive dysfunctions across multiple domains, including attention, memory, language, and executive functions.
|
takes about 10 minutes for administration.
|
|
Perception Impairment - Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)
Time Frame: Duration varies based on the number and type of subtests administered.
|
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.
|
|
Mental Evocation Ability - Mental Evocation of Images, Movements, and Activities Questionnaire (CEMIMA)
Time Frame: Duration varies
|
Measures the ability to mentally form visual and kinesthetic images of the hand/upper limb.
|
Duration varies
|
|
Quality of Life Perception - Stroke Impact Scale 16 (SIS-16)
Time Frame: 5-10 minutes.
|
A self-report measure focusing on physical aspects including strength, hand function, mobility, and ADLs.
|
5-10 minutes.
|
|
Electromyographic Activity During MI and AO
Time Frame: during the experimental setup
|
muscle activity using surface electrodes on wrist extensors and flexors.
|
during the experimental setup
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Age
Time Frame: 1 minute
|
birth age
|
1 minute
|
|
gender
Time Frame: 1 minute
|
he gender with which the participant identifies
|
1 minute
|
|
Marital Status
Time Frame: 1 minute
|
single, married, divorced
|
1 minute
|
|
Education Level
Time Frame: 1 minute
|
he highest level of education
|
1 minute
|
|
Economic Status
Time Frame: 1 minute
|
participant's economic
|
1 minute
|
|
Affected Side
Time Frame: 1 minute
|
The side of the body affected by the stroke or injury
|
1 minute
|
|
Dominant Side
Time Frame: 1 minute
|
The side of the body that is the participant's natural dominant side
|
1 minute
|
|
Type of Lesion
Time Frame: 1 minute
|
specific type of brain injury
|
1 minute
|
|
Time Since Injury
Time Frame: 1 minute
|
time since the participant had the brain injury or stroke.
|
1 minute
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MIAO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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