NCT06230718

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
9mo left

Started Jan 2024

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Jan 2024Jan 2027

Study Start

First participant enrolled

January 1, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Expected
Last Updated

October 7, 2025

Status Verified

October 1, 2025

Enrollment Period

2.1 years

First QC Date

January 19, 2024

Last Update Submit

October 2, 2025

Conditions

Keywords

Stroke rehabilitationElectromyographyNeuroplasticityUpper LinbNeurorehabilitation

Outcome Measures

Primary Outcomes (7)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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

  • 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.

  • Electromyographic Activity During MI and AO

    muscle activity using surface electrodes on wrist extensors and flexors.

    during the experimental setup

Secondary Outcomes (9)

  • Age

    1 minute

  • gender

    1 minute

  • Marital Status

    1 minute

  • Education Level

    1 minute

  • Economic Status

    1 minute

  • +4 more secondary outcomes

Study Arms (1)

Intervention group

EXPERIMENTAL

The intervention group will receive 3 experimental procedures 1. Placebo control 2. Motor Imagery- Active Comparator 3. Action Observation (OA) Active comparator muscle activation control by surface electromyography will be recorded in these three situations

Other: Motor Imagery (MI)Other: Action Observation (AO)Other: Control condition- placebo

Interventions

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.

Intervention group

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.

Intervention group

Recording with images of landscapes without the presence of any person or animal that could evoke MI or OA.

Intervention group

Eligibility Criteria

Age18 Years - 99 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsData collection forms include gender identity questions, and the gender identity is sellf-determined by participants
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Salmanca

Salamanca, Salamanca, 37007, Spain

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Beatriz María Bermejo Gil, Dr

CONTACT

Ana MAría Martín Nogueras, Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Patients will receive 3 interventions: placebo, motor imagery and action observation
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2024

First Posted

January 30, 2024

Study Start

January 1, 2024

Primary Completion

January 30, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

October 7, 2025

Record last verified: 2025-10

Locations