Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:09 AM
Study NCT ID:
NCT07428304
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cortical Changes After Upper Limb Immobilization Measured by Electroencephalography
Sponsor:
University of Malaga
Organization:
Study Overview
Official Title:
Effects of Upper Limb Immobilization on Sensorimotor Cortical Activity and Function Measured by EEG: A Prospective Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EEG
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 231-2025-H | REGISTRY | CEUMA | View |