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NCT Number: NCT07428304

Cortical Changes After Upper Limb Immobilization Measured by Electroencephalography

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Wrist Injury Arm Injuries Hand and Upper Limb Trauma Muskuloskeletal Diseases Wounds and Injuries Wrist Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UMA

Málaga, 29071, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Orthopedic Immobilization

Other

Standard orthopedic immobilization of the upper limb (wrist/hand) as part of routine clinical management following fracture or soft tissue injury.

Standard Rehabilitation

Other

Conventional wrist and hand rehabilitation provided according to clinical practice after immobilization removal.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Registry information

Official study title

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

Acronym: EEG

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 23, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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