Cortical Changes After Upper Limb Immobilization Measured by Electroencephalography

NCT07428304 | Active Not Recruiting

• 2 other identifiers: UMA-EEG-IMM-2026-002231-2025-H
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wrist Injury; Hand and Upper Limb Trauma; Muskuloskeletal Diseases

Keywords

Limb immobilization; Electroencephalography; Sensorimotor cortex; Functional recovery

Outcome Measures

Primary Outcomes (1)

• Change in Sensorimotor Cortical Activity Measured by EEG

  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 Outcomes (9)

• Change in Upper Limb Pain and Disability (PRWE)

  Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.

• Change in Upper Limb Functional Status (QuickDASH)

  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)

  Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.

• Change in Shoulder Pain and Disability (SPADI)

  Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.

• Change in Grip Strength

  Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.

Study Arms (1)

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; Other: Standard Rehabilitation

Interventions

Orthopedic Immobilization OTHER

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

Upper Limb Immobilization Cohort

Standard Rehabilitation OTHER

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

Upper Limb Immobilization Cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

UMA

Málaga, Málaga, 29071, Spain

Location

MeSH Terms

Conditions

Wrist Injuries

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-06

Locations

ES (1)