Wrist InjuryEEGNCT07428304
Cortical Changes After Upper Limb Immobilization Measured by Electroencephalography
An observational study of Wrist Injury and Hand and Upper Limb Trauma, run by University of Malaga at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Wrist Injury, Hand and Upper Limb Trauma, Muskuloskeletal Diseases
- What is being tested?
- Orthopedic Immobilization and Standard Rehabilitation
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2026to 1 Feb 2027
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Orthopedic Immobilization, Standard Rehabilitation
- Keywords
- Limb immobilization, Electroencephalography, Sensorimotor cortex, Functional recovery
- Medical subject headings
- Wrist Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthopedic ImmobilizationOther
Standard orthopedic immobilization of the upper limb (wrist/hand) as part of routine clinical management following fracture or soft tissue injury.
Standard RehabilitationOther
Conventional wrist and hand rehabilitation provided according to clinical practice after immobilization removal.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Orthopedic Immobilization; Other: Standard Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Change in Upper Limb Functional Status (QuickDASH)
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.
Measured: 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)
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.
Measured: Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Change in Shoulder Pain and Disability (SPADI)
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.
Measured: Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Change in Grip Strength
Grip strength measured in kilograms using a Jamar dynamometer under standardized positioning (shoulder adducted, elbow flexed 90°, forearm neutral). Bilateral measurements recorded.
Measured: Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Change in Wrist Range of Motion
Active wrist range of motion (flexion, extension) measured in degrees using a goniometer under standardized positioning.
Measured: Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Change in Joint Position Sense (Proprioception)
Joint Position Sense (JPS) error measured in degrees as the absolute difference between target and reproduced wrist position.
Measured: Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Change in Pain Catastrophizing (PCS)
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.
Measured: Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Change in Kinesiophobia (TSK-11)
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.
Measured: Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atenea Villalobos-García, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428304
- Sponsor's protocol ID
- UMA-EEG-IMM-2026-002
- Other IDs
- 231-2025-H
- Acronym
- EEG
- Status last verified
- Jun 2026
- First submitted
- 16 Feb 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Upper Limb Immobilization on Sensorimotor Cortical Activity and Function Measured by EEG: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07428304
- Acronym / sponsor ID
- EEG / UMA-EEG-IMM-2026-002
- Keywords
- Limb immobilization, Electroencephalography, Sensorimotor cortex, Functional recovery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upper Limb Immobilization Cohort | – | Other: Orthopedic Immobilization, Other: Standard RehabilitationAdults 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthopedic ImmobilizationStandard orthopedic immobilization of the upper limb (wrist/hand) as part of routine clinical management following fracture or soft tissue injury. | Other | Upper Limb Immobilization Cohort |
| Standard RehabilitationConventional wrist and hand rehabilitation provided according to clinical practice after immobilization removal. | Other | Upper Limb Immobilization Cohort |
Primary outcome
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.
9 secondary outcomes
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.
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.
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.
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.
Change in Grip Strength
Time frame: 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.
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.
Change in Pain Catastrophizing (PCS)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wrist Injury and Hand and Upper Limb Trauma, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.