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临床试验/NCT07425613
NCT07425613招募中不适用

Early Changes in Dynamic Cervical Movement Control Following Anterior Cervical Discectomy and Fusion: A Prospective Controlled Longitudinal Study

University of Ljubljana1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年2月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Change From Baseline in Time-on-Target at Medium Difficulty During Dynamic Cervical Head Tracking at 1 Week

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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:
  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Anterior Cervical Discectomy and Fusion (Procedure)

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.

结局指标

主要结局

Change From Baseline in Time-on-Target at Medium Difficulty During Dynamic Cervical Head Tracking at 1 Week

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Change From Baseline in Movement-Control Impairment Cluster Classification at 1 Week(Baseline (within 1 week prior to surgery) and 1 week after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ziva Majcen Rosker

Assistant Professor of Kinesiology, Faculty of Sport, University of Ljubljana

University of Ljubljana

研究点 (1)

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