Cervical Vertebral Disc DegenerationMOVE-ACDFNCT07425613
Cervical Movement Control Before and After Anterior Cervical Discectomy and Fusion
A study testing Anterior Cervical Discectomy and Fusion in people with Cervical Vertebral Disc Degeneration and Intervertebral Disc Displacement, run by University of Ljubljana at 1 site in Slovenia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Vertebral Disc Degeneration, Intervertebral Disc Displacement
- What is being tested?
- Anterior Cervical Discectomy and Fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSlovenia
- Study dates
- 20 Feb 2026to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgical group:
- 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
- Non-Surgical neck pain group:
Show all 10Show fewer
- Age 18 to 65 years
- Clinical diagnosis of neck pain associated with cervical disc pathology
- Not undergoing surgical treatment during the study period
- Ability to understand study procedures and provide written informed consent
Who cannot join
- 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
- Acute musculoskeletal injury of the neck or upper limb unrelated to the primary cervical condition
- Inability to perform the head-tracking task
- Cognitive impairment preventing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Changes in Dynamic Cervical Movement Control Following Anterior Cervical Discectomy and Fusion: A Prospective Controlled Longitudinal Study
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.
Read more
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.
Read the detailed description
Detailed Description Degenerative cervical disc disease is commonly associated with neck pain and neurological symptoms. In addition to these clinical manifestations, increasing evidence indicates that cervical spine pathology may impair cervical sensorimotor control. The cervical spine contains a high density of muscle spindles and joint mechanoreceptors that provide afferent information about head position and movement. This sensory input is integrated with visual and vestibular systems to regulate head-neck coordination and postural stability. Structural degeneration or neural compression may disrupt afferent signaling and alter this integration, potentially contributing to impaired movement accuracy, dizziness, or imbalance.
Anterior cervical discectomy and fusion (ACDF) is a standard surgical procedure used to relieve nerve root or spinal cord compression caused by cervical disc herniation when conservative treatment fails. While ACDF has demonstrated effectiveness in reducing pain and neurological deficits, its effects on objective cervical movement-control measures remain insufficiently characterized.
The RECAL-ACDF study is a prospective controlled longitudinal investigation designed to evaluate early changes in dynamic cervical movement control following ACDF. The study compares patients undergoing ACDF with time-matched healthy control participants assessed over the same time interval.
Study Design
Participants in the surgical group will be assessed at two time points:
- Preoperative baseline (within one week prior to surgery)
- One week postoperatively Healthy control participants will be assessed at two time points separated by a comparable interval.
The study uses a parallel-group, non-randomized design. The primary purpose is mechanistic evaluation of sensorimotor function.
Assessment of Cervical Movement Control Cervical movement control will be assessed using a validated dynamic head-tracking task (Butterfly test) implemented through the NeckSmart system (NeckCare™, Reykjavik, Iceland). The system uses a head-mounted inertial measurement unit (IMU) to record head movements while participants track an unpredictably moving visual target displayed on a computer screen.
The task includes three predefined difficulty levels (easy, medium, difficult), characterized by increasing target velocity and trajectory complexity. For each difficulty level, three trials will be performed.
The following outcome measures will be derived:
- Time-on-target (percentage of total trial time within the target zone)
- Undershoot (percentage of total trial time behind the target)
- Overshoot (percentage of total trial time in front of the target)
- Amplitude accuracy (mean spatial deviation between target and head-controlled cursor, expressed in millimeters)
Mean values across repetitions will be used for statistical analyses.
Primary Objective To determine whether ACDF results in short-term improvements in dynamic cervical movement control compared with healthy controls over the same time period.
The primary outcome measure is the change in time-on-target at medium difficulty (ToT_m) from baseline to one week postoperatively.
Secondary Objectives
- To evaluate changes in additional movement-control parameters across difficulty levels.
- To assess change in amplitude accuracy at difficult level (AA_d).
- To determine whether surgery is associated with redistribution across predefined multidimensional movement-control impairment clusters (four ordinal severity levels).
- To explore whether parameter-level improvements correspond to broader changes in impairment phenotype.
Cluster allocation (severity levels 1-4) will be determined using a previously established multidimensional classification framework based on standardized movement-control parameters.
Hypothesis It is hypothesized that patients undergoing ACDF will demonstrate measurable improvement in selected dynamic movement-control parameters one week after surgery. However, categorical redistribution across multidimensional impairment clusters may not occur in the early postoperative period.
This study conceptualizes postoperative recovery as an early sensorimotor recalibration process rather than immediate normalization of movement-control phenotype.
Statistical Approach The primary analysis will compare change scores (postoperative minus preoperative values) between the surgical and control groups. Appropriate parametric or nonparametric statistical tests will be applied depending on data distribution. Multiple comparisons will be controlled using the Holm-Bonferroni procedure.
Cluster allocation (ordinal severity levels 1-4) will be analyzed using proportional odds regression models with subject-level clustering to account for repeated measurements.
Clinical Relevance This study aims to clarify whether structural decompression of the cervical spine is associated with early recalibration of cervical sensorimotor control. Improved understanding of postoperative sensorimotor changes may inform development of targeted rehabilitation strategies following ACDF.
- Being tested
- Anterior Cervical Discectomy and Fusion
- Keywords
- Anterior Cervical Discectomy and Fusion, Cervical Sensorimotor Control, Cervicocephalic Kinaesthesia, Head and neck movement control test, Postoperative Recovery, Cervical Spine Surgery, Movement Control, Neck Proprioception
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Cervical Discectomy and FusionProcedure or surgery
Anterior 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.
| Study group | Role | What they receive |
|---|---|---|
| Anterior Cervical Discectomy and Fusion (ACDF) | Experimental | Participants diagnosed with cervical disc pathology and scheduled to undergo anterior cervical discectomy and fusion (ACDF) as part of standard clinical care. Cervical movement control will be assessed within one week prior to surgery and again one week after surgery using a standardized dynamic head-tracking task. Changes in movement-control parameters will be analyzed to evaluate early postoperative sensorimotor changes. Receives: Procedure: Anterior Cervical Discectomy and Fusion |
| Non-Surgical Neck Pain Group | No intervention | Participants diagnosed with neck pain who are not undergoing surgical treatment will serve as the comparison group. These participants will be assessed at two time points separated by a comparable interval to the surgical group. Cervical movement control will be evaluated using the same standardized dynamic head-tracking task. No surgical intervention will be performed during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (within 1 week prior to surgery) and 1 week after surgery
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.
Measured: Baseline (within 1 week prior to surgery) and 1 week after surgery
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.
Measured: Baseline (within 1 week prior to surgery) and 1 week after surgery
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.
Measured: Baseline (within 1 week prior to surgery) and 1 week after surgery
Secondary 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.
Measured: Baseline (within 1 week prior to surgery) and 1 week after surgery
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 start20 Feb 2026
- Primary completion15 Mar 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Cervical Vertebral Disc DegenerationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a non-randomized parallel assignment design. Participants undergoing anterior cervical discectomy and fusion (ACDF) for cervical disc pathology are assigned to the surgical group and assessed at two time points: preoperatively and one week postoperatively. A matched comparison group of patients with neck pain who are not undergoing surgical treatment is assessed at two time points separated by a comparable interval without receiving surgery. The study compares changes in cervical movement-control measures between the surgical and non-surgical groups over the same time period.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Centre Ljubljana
- Responsible party
- Sponsor
- Investigators
- Ziva Majcen Rosker, PhD, Principal investigator, Faculty of Sport, University of Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425613
- Sponsor's protocol ID
- FS-UL-CDISECT-2026-01
- Acronym
- MOVE-ACDF
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected in this study will not be made publicly available. The sample size is relatively small and includes patients treated at a single clinical center, which may increase the risk of indirect participant identification despite de-identification procedures. Additionally, the dataset includes detailed movement-control performance variables and clinical characteristics that could potentially allow re-identification when combined with other publicly available information. Data were collected under informed consent and ethics approval that did not include provisions for public sharing of individual-level data. Aggregate results will be reported in scientific publications to ensure transparency while maintaining participant confidentiality.
Publications
Zheng HL, Li B, Song SK, Chen PB, Jiang LS, Jiang SD. Anterior cervical discectomy and fusion to treat cervical instability with vertigo and dizziness: A single center, retrospective, observational study. Front Surg. 2023 Jan 6;9:1047504. doi: 10.3389/fsurg.2022.1047504. eCollection 2022.
PubMed 36684132Yang L, Yang C, Pang X, Li D, Yang H, Zhang X, Yang Y, Peng B. Mechanoreceptors in Diseased Cervical Intervertebral Disc and Vertigo. Spine (Phila Pa 1976). 2017 Apr 15;42(8):540-546. doi: 10.1097/BRS.0000000000001801.
PubMed 27438387Wrisley DM, Sparto PJ, Whitney SL, Furman JM. Cervicogenic dizziness: a review of diagnosis and treatment. J Orthop Sports Phys Ther. 2000 Dec;30(12):755-66. doi: 10.2519/jospt.2000.30.12.755.
PubMed 11153554Treleaven J. Sensorimotor disturbances in neck disorders affecting postural stability, head and eye movement control--Part 2: case studies. Man Ther. 2008 Jun;13(3):266-75. doi: 10.1016/j.math.2007.11.002. Epub 2008 Jan 3.
PubMed 18180194Takayama H, Muratsu H, Doita M, Harada T, Kurosaka M, Yoshiya S. Proprioceptive recovery of patients with cervical myelopathy after surgical decompression. Spine (Phila Pa 1976). 2005 May 1;30(9):1039-44. doi: 10.1097/01.brs.0000160988.40890.1d.
PubMed 15864156Peng B. Cervical Vertigo: Historical Reviews and Advances. World Neurosurg. 2018 Jan;109:347-350. doi: 10.1016/j.wneu.2017.10.063. Epub 2017 Oct 20.
PubMed 29061460Mendel T, Wink CS, Zimny ML. Neural elements in human cervical intervertebral discs. Spine (Phila Pa 1976). 1992 Feb;17(2):132-5. doi: 10.1097/00007632-199202000-00002.
PubMed 1372767Majcen Rosker Z, Vodicar M, Kristjansson E. Is Altered Oculomotor Control during Smooth Pursuit Neck Torsion Test Related to Subjective Visual Complaints in Patients with Neck Pain Disorders? Int J Environ Res Public Health. 2022 Mar 23;19(7):3788. doi: 10.3390/ijerph19073788.
PubMed 35409472Majcen Rosker Z, Rosker J. Cervicocephalic kinaesthesia reveals novel subgroups of motor control impairments in patients with neck pain. Sci Rep. 2024 Apr 10;14(1):8383. doi: 10.1038/s41598-024-57326-1.
PubMed 38600120Majcen Rosker Z, Kristjansson E, Vodicar M. How well can we detect cervical driven sensorimotor dysfunction in concussion patients? An observational study comparing patients with idiopathic neck pain, whiplash associated disorders and concussion. Gait Posture. 2023 Mar;101:21-27. doi: 10.1016/j.gaitpost.2023.01.011. Epub 2023 Jan 16.
PubMed 36701850Magnusson M, Malmstrom EM. The conundrum of cervicogenic dizziness. Handb Clin Neurol. 2016;137:365-9. doi: 10.1016/B978-0-444-63437-5.00026-1.
PubMed 27638084Liu TH, Liu YQ, Peng BG. Cervical intervertebral disc degeneration and dizziness. World J Clin Cases. 2021 Mar 26;9(9):2146-2152. doi: 10.12998/wjcc.v9.i9.2146.
PubMed 33850933Kristjansson E, Treleaven J. Sensorimotor function and dizziness in neck pain: implications for assessment and management. J Orthop Sports Phys Ther. 2009 May;39(5):364-77. doi: 10.2519/jospt.2009.2834.
PubMed 19411769CLOWARD RB. The anterior approach for removal of ruptured cervical disks. J Neurosurg. 1958 Nov;15(6):602-17. doi: 10.3171/jns.1958.15.6.0602. No abstract available.
PubMed 13599052Boyd-Clark LC, Briggs CA, Galea MP. Muscle spindle distribution, morphology, and density in longus colli and multifidus muscles of the cervical spine. Spine (Phila Pa 1976). 2002 Apr 1;27(7):694-701. doi: 10.1097/00007632-200204010-00005.
PubMed 11923661
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Changes in Dynamic Cervical Movement Control Following Anterior Cervical Discectomy and Fusion: A Prospective Controlled Longitudinal Study
- ClinicalTrials.gov ID
- NCT07425613
- Acronym / sponsor ID
- MOVE-ACDF / FS-UL-CDISECT-2026-01
- Keywords
- Anterior Cervical Discectomy and Fusion, Cervical Sensorimotor Control, Cervicocephalic Kinaesthesia, Head and neck movement control test, Postoperative Recovery, Cervical Spine Surgery, Movement Control, Neck Proprioception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Collaborators
- University Medical Centre Ljubljana
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- 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.
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.
Detailed description
Detailed Description Degenerative cervical disc disease is commonly associated with neck pain and neurological symptoms. In addition to these clinical manifestations, increasing evidence indicates that cervical spine pathology may impair cervical sensorimotor control. The cervical spine contains a high density of muscle spindles and joint mechanoreceptors that provide afferent information about head position and movement. This sensory input is integrated with visual and vestibular systems to regulate head-neck coordination and postural stability. Structural degeneration or neural compression may disrupt afferent signaling and alter this integration, potentially contributing to impaired movement accuracy, dizziness, or imbalance.
Anterior cervical discectomy and fusion (ACDF) is a standard surgical procedure used to relieve nerve root or spinal cord compression caused by cervical disc herniation when conservative treatment fails. While ACDF has demonstrated effectiveness in reducing pain and neurological deficits, its effects on objective cervical movement-control measures remain insufficiently characterized.
The RECAL-ACDF study is a prospective controlled longitudinal investigation designed to evaluate early changes in dynamic cervical movement control following ACDF. The study compares patients undergoing ACDF with time-matched healthy control participants assessed over the same time interval.
Study Design
Participants in the surgical group will be assessed at two time points:
- Preoperative baseline (within one week prior to surgery)
- One week postoperatively Healthy control participants will be assessed at two time points separated by a comparable interval.
The study uses a parallel-group, non-randomized design. The primary purpose is mechanistic evaluation of sensorimotor function.
Assessment of Cervical Movement Control Cervical movement control will be assessed using a validated dynamic head-tracking task (Butterfly test) implemented through the NeckSmart system (NeckCare™, Reykjavik, Iceland). The system uses a head-mounted inertial measurement unit (IMU) to record head movements while participants track an unpredictably moving visual target displayed on a computer screen.
The task includes three predefined difficulty levels (easy, medium, difficult), characterized by increasing target velocity and trajectory complexity. For each difficulty level, three trials will be performed.
The following outcome measures will be derived:
- Time-on-target (percentage of total trial time within the target zone)
- Undershoot (percentage of total trial time behind the target)
- Overshoot (percentage of total trial time in front of the target)
- Amplitude accuracy (mean spatial deviation between target and head-controlled cursor, expressed in millimeters)
Mean values across repetitions will be used for statistical analyses.
Primary Objective To determine whether ACDF results in short-term improvements in dynamic cervical movement control compared with healthy controls over the same time period.
The primary outcome measure is the change in time-on-target at medium difficulty (ToT_m) from baseline to one week postoperatively.
Secondary Objectives
- To evaluate changes in additional movement-control parameters across difficulty levels.
- To assess change in amplitude accuracy at difficult level (AA_d).
- To determine whether surgery is associated with redistribution across predefined multidimensional movement-control impairment clusters (four ordinal severity levels).
- To explore whether parameter-level improvements correspond to broader changes in impairment phenotype.
Cluster allocation (severity levels 1-4) will be determined using a previously established multidimensional classification framework based on standardized movement-control parameters.
Hypothesis It is hypothesized that patients undergoing ACDF will demonstrate measurable improvement in selected dynamic movement-control parameters one week after surgery. However, categorical redistribution across multidimensional impairment clusters may not occur in the early postoperative period.
This study conceptualizes postoperative recovery as an early sensorimotor recalibration process rather than immediate normalization of movement-control phenotype.
Statistical Approach The primary analysis will compare change scores (postoperative minus preoperative values) between the surgical and control groups. Appropriate parametric or nonparametric statistical tests will be applied depending on data distribution. Multiple comparisons will be controlled using the Holm-Bonferroni procedure.
Cluster allocation (ordinal severity levels 1-4) will be analyzed using proportional odds regression models with subject-level clustering to account for repeated measurements.
Clinical Relevance This study aims to clarify whether structural decompression of the cervical spine is associated with early recalibration of cervical sensorimotor control. Improved understanding of postoperative sensorimotor changes may inform development of targeted rehabilitation strategies following ACDF.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a non-randomized parallel assignment design. Participants undergoing anterior cervical discectomy and fusion (ACDF) for cervical disc pathology are assigned to the surgical group and assessed at two time points: preoperatively and one week postoperatively. A matched comparison group of patients with neck pain who are not undergoing surgical treatment is assessed at two time points separated by a comparable interval without receiving surgery. The study compares changes in cervical movement-control measures between the surgical and non-surgical groups over the same time period.
| Arm | Type | Receives |
|---|---|---|
| Anterior Cervical Discectomy and Fusion (ACDF) | Experimental | Procedure: Anterior Cervical Discectomy and FusionParticipants diagnosed with cervical disc pathology and scheduled to undergo anterior cervical discectomy and fusion (ACDF) as part of standard clinical care. Cervical movement control will be assessed within one week prior to surgery and again one week after surgery using a standardized dynamic head-tracking task. Changes in movement-control parameters will be analyzed to evaluate early postoperative sensorimotor changes. |
| Non-Surgical Neck Pain Group | No intervention | –Participants diagnosed with neck pain who are not undergoing surgical treatment will serve as the comparison group. These participants will be assessed at two time points separated by a comparable interval to the surgical group. Cervical movement control will be evaluated using the same standardized dynamic head-tracking task. No surgical intervention will be performed during the study period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Age 18 to 65 years
Key exclusion criteria (7 listed)
- 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
- Acute musculoskeletal injury of the neck or upper limb unrelated to the primary cervical condition
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 |
|---|---|---|
| Anterior Cervical Discectomy and FusionAnterior 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. | Procedure or surgery | Anterior Cervical Discectomy and Fusion (ACDF) |
Primary outcome
Change From Baseline in Time-on-Target at Medium Difficulty During Dynamic Cervical Head Tracking at 1 Week
Time frame: Baseline (within 1 week prior to surgery) and 1 week after surgery
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.
Change From Baseline in Amplitude Accuracy During Dynamic Cervical Head Tracking at 1 Week
Time frame: Baseline (within 1 week prior to surgery) and 1 week after surgery
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.
Change From Baseline in Undershoot During Dynamic Cervical Head Tracking at 1 Week
Time frame: Baseline (within 1 week prior to surgery) and 1 week after surgery
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.
Change From Baseline in Overshoot During Dynamic Cervical Head Tracking at 1 Week
Time frame: Baseline (within 1 week prior to surgery) and 1 week after surgery
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.
1 secondary outcome
Change From Baseline in Movement-Control Impairment Cluster Classification at 1 Week
Time frame: Baseline (within 1 week prior to surgery) and 1 week after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 36684132Zheng HL, Li B, Song SK, Chen PB, Jiang LS, Jiang SD. Anterior cervical discectomy and fusion to treat cervical instability with vertigo and dizziness: A single center, retrospective, observational study. Front Surg. 2023 Jan 6;9:1047504. doi: 10.3389/fsurg.2022.1047504. eCollection 2022.
- Background: PubMed 27438387Yang L, Yang C, Pang X, Li D, Yang H, Zhang X, Yang Y, Peng B. Mechanoreceptors in Diseased Cervical Intervertebral Disc and Vertigo. Spine (Phila Pa 1976). 2017 Apr 15;42(8):540-546. doi: 10.1097/BRS.0000000000001801.
- Background: PubMed 11153554Wrisley DM, Sparto PJ, Whitney SL, Furman JM. Cervicogenic dizziness: a review of diagnosis and treatment. J Orthop Sports Phys Ther. 2000 Dec;30(12):755-66. doi: 10.2519/jospt.2000.30.12.755.
- Background: PubMed 18180194Treleaven J. Sensorimotor disturbances in neck disorders affecting postural stability, head and eye movement control--Part 2: case studies. Man Ther. 2008 Jun;13(3):266-75. doi: 10.1016/j.math.2007.11.002. Epub 2008 Jan 3.
- Background: PubMed 15864156Takayama H, Muratsu H, Doita M, Harada T, Kurosaka M, Yoshiya S. Proprioceptive recovery of patients with cervical myelopathy after surgical decompression. Spine (Phila Pa 1976). 2005 May 1;30(9):1039-44. doi: 10.1097/01.brs.0000160988.40890.1d.
- Background: PubMed 29061460Peng B. Cervical Vertigo: Historical Reviews and Advances. World Neurosurg. 2018 Jan;109:347-350. doi: 10.1016/j.wneu.2017.10.063. Epub 2017 Oct 20.
- Background: PubMed 1372767Mendel T, Wink CS, Zimny ML. Neural elements in human cervical intervertebral discs. Spine (Phila Pa 1976). 1992 Feb;17(2):132-5. doi: 10.1097/00007632-199202000-00002.
- Background: PubMed 35409472Majcen Rosker Z, Vodicar M, Kristjansson E. Is Altered Oculomotor Control during Smooth Pursuit Neck Torsion Test Related to Subjective Visual Complaints in Patients with Neck Pain Disorders? Int J Environ Res Public Health. 2022 Mar 23;19(7):3788. doi: 10.3390/ijerph19073788.
- Background: PubMed 38600120Majcen Rosker Z, Rosker J. Cervicocephalic kinaesthesia reveals novel subgroups of motor control impairments in patients with neck pain. Sci Rep. 2024 Apr 10;14(1):8383. doi: 10.1038/s41598-024-57326-1.
- Background: PubMed 36701850Majcen Rosker Z, Kristjansson E, Vodicar M. How well can we detect cervical driven sensorimotor dysfunction in concussion patients? An observational study comparing patients with idiopathic neck pain, whiplash associated disorders and concussion. Gait Posture. 2023 Mar;101:21-27. doi: 10.1016/j.gaitpost.2023.01.011. Epub 2023 Jan 16.
- Background: PubMed 27638084Magnusson M, Malmstrom EM. The conundrum of cervicogenic dizziness. Handb Clin Neurol. 2016;137:365-9. doi: 10.1016/B978-0-444-63437-5.00026-1.
- Background: PubMed 33850933Liu TH, Liu YQ, Peng BG. Cervical intervertebral disc degeneration and dizziness. World J Clin Cases. 2021 Mar 26;9(9):2146-2152. doi: 10.12998/wjcc.v9.i9.2146.
- Individual participant dataSharing planned: No. Individual participant data collected in this study will not be made publicly available. The sample size is relatively small and includes patients treated at a single clinical center, which may increase the risk of indirect participant identification despite de-identification procedures. Additionally, the dataset includes detailed movement-control performance variables and clinical characteristics that could potentially allow re-identification when combined with other publicly available information. Data were collected under informed consent and ethics approval that did not include provisions for public sharing of individual-level data. Aggregate results will be reported in scientific publications to ensure transparency while maintaining participant confidentiality.
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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.
Ziva Majcen Rosker, PhD principal investigator
Faculty of Sport, University of Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior Cervical Discectomy and Fusion in people with Cervical Vertebral Disc Degeneration and Intervertebral Disc Displacement, run by University of Ljubljana at 1 site in Slovenia.
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 10 inclusion and 7 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: finished, as of the sponsor's last update on 27 Oct 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 Slovenia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 From Baseline in Time-on-Target at Medium Difficulty During Dynamic Cervical Head Tracking at 1 Week (time frame: Baseline (within 1 week prior to surgery) and 1 week after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07425613, which also lists 16 linked publications.
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 27 Oct 2026.