Cortical Changes After Upper Limb Immobilization Measured by Electroencephalography (EEG)

June 2, 2026 updated by: Atenea Villalobos-García, University of Malaga

Effects of Upper Limb Immobilization on Sensorimotor Cortical Activity and Function Measured by EEG: A Prospective Observational Study

This study aims to investigate how temporary immobilization of the upper limb after injury affects brain activity and functional recovery.

Participants with fractures or soft tissue injuries of the upper limb who require immobilization will be evaluated at three time points: at the beginning of immobilization, after removal of the immobilization, and four weeks later.

Brain activity will be measured using electroencephalography (EEG), a non-invasive and painless technique that records electrical signals from the scalp. Functional outcomes such as pain, mobility, strength, and daily activity performance will also be assessed using validated questionnaires and clinical tests.

The purpose of this study is to better understand how immobilization influences the brain and physical recovery, in order to improve rehabilitation strategies for patients with upper limb injuries.

Participation is voluntary, and all participants will provide written informed consent.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Upper limb immobilization is commonly required after fractures and soft tissue injuries to promote healing. However, prolonged immobilization can lead to muscle weakness, sensory deficits, and changes in brain activity related to motor control.

Previous research has shown that even short periods of limb disuse can induce neuroplastic changes in the sensorimotor cortex. These changes may contribute to persistent functional limitations after immobilization is removed.

This prospective observational study aims to describe and quantify changes in sensorimotor cortical activity and functional outcomes associated with clinical immobilization of the upper limb.

Adult patients requiring immobilization for upper limb fractures or soft tissue injuries will be recruited. Eligible participants will be evaluated at three time points: baseline (within five days of immobilization), post-immobilization (within 24-48 hours after removal), and follow-up (four weeks after post-immobilization).

Brain activity will be recorded using a portable wireless electroencephalography (EEG) system following the international 10-20 electrode placement system. Resting-state and task-related recordings will be obtained. Spectral power in standard frequency bands and functional connectivity measures will be analyzed.

Clinical and functional outcomes will include patient-reported questionnaires (PRWE, QuickDASH, MHQ, SPADI, TSK-11, PCS), range of motion, grip strength, and joint position sense.

Statistical analyses will focus on longitudinal changes across time points using repeated-measures analysis of variance or mixed-effects models, depending on data distribution. Effect sizes and confidence intervals will be reported.

This study has been approved by the local ethics committee, and all participants will provide written informed consent prior to participation.

The results are expected to contribute to a better understanding of brain plasticity during immobilization and support the development of more effective rehabilitation strategies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Málaga
      • Málaga, Málaga, Spain, 29071
        • UMA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult patients requiring orthopedic immobilization of the upper limb following fracture or soft tissue injury. Participants are consecutively referred from the traumatology units of hospitals in Málaga and undergo clinical and neurophysiological evaluation under supervision of the research team. The study population represents individuals undergoing routine clinical immobilization and subsequent rehabilitation as part of standard orthopedic management.

Description

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Radiologically confirmed upper limb fracture (distal radius, proximal humerus, metacarpals, phalanges, or carpal bones) or soft tissue injury (e.g., tendinopathy, triangular fibrocartilage complex injury).
  • Requirement of orthopedic immobilization of the wrist/hand extending to the proximal two-thirds of the forearm for a minimum of 2 weeks and a maximum of 8 weeks.
  • Ability to understand study procedures and follow instructions.
  • Provision of written informed consent.

Exclusion Criteria:

  • History of neurological disorders (e.g., stroke, epilepsy, traumatic brain injury).
  • Current use of psychoactive or anticonvulsant medication.
  • Bilateral upper limb injuries.
  • Wrist fractures requiring elbow immobilization.
  • Previous upper limb fracture or instability within the last 2 years.
  • Cognitive impairment preventing adequate participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Upper Limb Immobilization Cohort
Adults with upper limb fracture or soft tissue injury requiring orthopedic immobilization for 2-8 weeks. Participants undergo repeated neurophysiological and clinical assessments at baseline (within 5 days from the start of immobilization), post-immobilization (within 24-48 hours after removal of the immobilization), and 4-week follow-up (4 weeks after splint or cast removal).
Other: Orthopedic Immobilization
Standard orthopedic immobilization of the upper limb (wrist/hand) as part of routine clinical management following fracture or soft tissue injury.
Other: Standard Rehabilitation
Conventional wrist and hand rehabilitation provided according to clinical practice after immobilization removal.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Sensorimotor Cortical Activity Measured by EEG
Time Frame: Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Changes in sensorimotor cortical activity measured using electroencephalography (EEG), including spectral power in mu (8-13 Hz) and beta (13-30 Hz) frequency bands over central regions (C3, C4 and adjacent electrodes), and functional connectivity between motor and somatosensory areas.
Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Upper Limb Pain and Disability (PRWE)
Time Frame: Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Patient-Rated Wrist Evaluation (PRWE) total score (0-100), assessing pain and functional disability of the wrist and hand. Higher scores indicate greater pain and disability.
Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Change in Upper Limb Functional Status (QuickDASH)
Time Frame: Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH), 11-item self-reported measure of upper limb disability (0-100). Higher scores indicate greater disability.
Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Change in Hand Function (Michigan Hand Outcomes Questionnaire)
Time Frame: Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Michigan Hand Outcomes Questionnaire (MHQ) total score assessing hand function, activities of daily living, pain, work performance, aesthetics, and satisfaction. Scores range from 0 to 100 depending on domain.
Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Change in Shoulder Pain and Disability (SPADI)
Time Frame: Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Shoulder Pain and Disability Index (SPADI), 13-item questionnaire assessing shoulder pain and disability. Scores range from 0 to 100, with higher scores indicating greater impairment.
Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Change in Grip Strength
Time Frame: Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Grip strength measured in kilograms using a Jamar dynamometer under standardized positioning (shoulder adducted, elbow flexed 90°, forearm neutral). Bilateral measurements recorded.
Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Change in Wrist Range of Motion
Time Frame: Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Active wrist range of motion (flexion, extension) measured in degrees using a goniometer under standardized positioning.
Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Change in Joint Position Sense (Proprioception)
Time Frame: Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Joint Position Sense (JPS) error measured in degrees as the absolute difference between target and reproduced wrist position.
Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Change in Pain Catastrophizing (PCS)
Time Frame: Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Pain Catastrophizing Scale (PCS), a 13-item self-reported questionnaire assessing rumination, magnification, and helplessness related to pain. Each item is scored from 0 to 4. Total scores range from 0 to 52, with higher scores indicating greater pain catastrophizing.
Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Change in Kinesiophobia (TSK-11)
Time Frame: Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Tampa Scale for Kinesiophobia (TSK-11), an 11-item self-reported questionnaire measuring fear of movement and reinjury. Each item is rated on a 4-point Likert scale. Total scores range from 11 to 44, with higher scores indicating greater fear of movement.
Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Malaga

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UMA-EEG-IMM-2026-002
  • 231-2025-H (Registry Identifier: CEUMA)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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