Cervical Movement Control Before and After Anterior Cervical Discectomy and Fusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Ljubljana
About this trial
Degenerative cervical disc disease can cause neck pain, nerve symptoms, dizziness, and problems with balance and head movement control. The neck contains many sensory receptors that provide information about head position and movement to the brain. When cervical discs degenerate or compress nearby structures, this sensory communication may be disrupted. As a result, patients may experience reduced accuracy and coordination of head movements.
Anterior cervical discectomy and fusion (ACDF) is a standard surgical procedure used to relieve nerve or spinal cord compression caused by cervical disc disease. The procedure is effective in reducing pain and neurological symptoms. However, it is not well understood whether ACDF also improves the way the neck and nervous system work together to control head movement.
The purpose of this study is to evaluate early changes in cervical movement control after ACDF. Patients scheduled for ACDF will be assessed before surgery and again one week after surgery. A group of healthy participants without neck pain will be assessed at the same time interval for comparison.
Cervical movement control will be measured using a computer-based head-tracking task. During this task, participants follow a moving target on a screen using controlled head movements. The system records measures of tracking accuracy and timing.
The primary research question is whether ACDF results in measurable short-term improvements in objective cervical movement control compared with healthy individuals over the same time period.
It is hypothesized that patients undergoing ACDF will demonstrate improvement in specific movement-control measures after surgery. However, broader patterns of movement-control impairment may not fully normalize in the early postoperative period.
The results of this study may improve understanding of how cervical spine surgery affects sensorimotor function and may help inform postoperative rehabilitation strategies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 65 years
Clinical diagnosis of cervical disc pathology at one segment level (e.g., cervical disc herniation or degenerative disc disease)
Scheduled to undergo anterior cervical discectomy and fusion (ACDF) as part of standard clinical care
Ability to understand study procedures and provide written informed consent
Disqualifiers
Prior cervical spine surgery
Diagnosed neurological disorders unrelated to cervical disc pathology (e.g., multiple sclerosis, Parkinson's disease, stroke)
Known vestibular disorders affecting balance
Severe uncorrected visual impairment
Trial design
Design model
Parallel
Treatments tested in this trial
Anterior Cervical Discectomy and Fusion
Procedure/SurgeryAnterior cervical discectomy and fusion (ACDF) is a surgical procedure performed under general anesthesia to treat cervical disc herniation or degenerative disc disease causing nerve root or spinal cord compression. The procedure involves an anterior approach to the cervical spine, removal of the affected intervertebral disc (discectomy), decompression of neural structures, and placement of an interbody graft or cage with or without anterior plate fixation to achieve segmental fusion. The specific surgical technique and implant selection are determined by the treating spine surgeon according to standard clinical practice.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Anterior Cervical Discectomy and Fusion (ACDF)Experimental treatment 1 intervention
Group B: Non-Surgical Neck Pain GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change From Baseline in Time-on-Target at Medium Difficulty During Dynamic Cervical Head Tracking at 1 Week
Time-on-target is defined as the percentage of total trial time during which the head-controlled cursor remains within a predefined target zone while following an unpredictably moving visual target on a computer screen. Head motion is recorded using a head-mounted inertial measurement unit during a standardized dynamic tracking task. The medium difficulty level involves predefined target speed and trajectory complexity. Values range from 0% to 100%, with higher percentages indicating better tracking accuracy and movement control. Change from baseline to one week postoperatively will be calculated for analysis.
Time frame
Baseline (within 1 week prior to surgery) and 1 week after surgery2
Change From Baseline in Amplitude Accuracy During Dynamic Cervical Head Tracking at 1 Week
Amplitude accuracy is defined as the mean spatial deviation, expressed in millimeters (mm), between a moving visual target and the head-controlled cursor during a standardized dynamic head-tracking task. Head motion is recorded using a head-mounted inertial measurement unit. Values are continuous and expressed in millimeters, with lower values indicating better tracking precision and movement control. Change from baseline to one week postoperatively will be calculated for analysis.
Time frame
Baseline (within 1 week prior to surgery) and 1 week after surgery3
Change From Baseline in Undershoot During Dynamic Cervical Head Tracking at 1 Week
Undershoot is defined as the percentage of total trial time during which the head-controlled cursor remains behind the moving visual target while performing a standardized dynamic head-tracking task. Head motion is recorded using a head-mounted inertial measurement unit. Values range from 0% to 100%, with lower percentages indicating better tracking performance and improved temporal control. Change from baseline to one week postoperatively will be calculated for analysis.
Time frame
Baseline (within 1 week prior to surgery) and 1 week after surgery4
Change From Baseline in Overshoot During Dynamic Cervical Head Tracking at 1 Week
Overshoot is defined as the percentage of total trial time during which the head-controlled cursor moves ahead of the moving visual target during a standardized dynamic head-tracking task. Head motion is recorded using a head-mounted inertial measurement unit. Values range from 0% to 100%, with lower percentages indicating better tracking precision and movement regulation. Change from baseline to one week postoperatively will be calculated for analysis.
Time frame
Baseline (within 1 week prior to surgery) and 1 week after surgerySecondary outcomes
1
Change From Baseline in Movement-Control Impairment Cluster Classification at 1 Week
Cluster classification represents an ordinal movement-control impairment category derived from multiple dynamic head-tracking parameters. Participants are assigned to one of four predefined severity levels (Cluster 1-4) using a standardized multidimensional classification framework based on tracking accuracy and timing variables. Cluster 1 indicates least impairment and Cluster 4 indicates greatest impairment. Change from baseline to one week postoperatively will be evaluated to determine whether participants shift to a lower or higher impairment category.
Time frame
Baseline (within 1 week prior to surgery) and 1 week after surgerySponsors and contacts
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University of Ljubljana
Lead sponsor
University Medical Centre Ljubljana
Collaborator
Source ClinicalTrials.gov