Clinical trial NCT06279377: Examining the Effectiveness of Exercise Training After Cervical Laminoplasty Surgery
Official title: Evaluation of the Efficacy of Stabilization Exercise Training After Cervical Laminoplasty Surgery: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Spine Disease
Surgery
Rehabilitation
Exercise
Keywords: Cervical Laminoplasty
Exercise Training
Stabilization Exercises
Early Exercise
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the effects of the stabilization exercise program applied after cervical laminoplasty surgery compared to standard exercise on pain, dysfunction, normal joint movement, proprioception, balance, muscle endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level). The main question\[s\] it aims to answer are:

* Does the exercise program applied after cervical laminoplasty surgery have an effect on pain, dysfunction, normal joint movement, proprioception, balance, muscle endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level)?
* Does the stabilization exercise program applied after cervical laminoplasty surgery have an effect on pain, dysfunction, normal joint movement, proprioception, balance, muscle endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level)?

Patients will start their first exercise session on the day they will be discharged from the hospital. Patients in both exercise groups will be provided with cervical normal joint movement (ROM), posture and patient education on the day of discharge. They will be asked to do posture exercises and neck exercises under the guidance of a physiotherapist. Patients in the stabilization exercise group (experiment) will undergo stabilization exercises under the supervision of a physiotherapist, in addition to the practices in the standard exercise group. Both groups will do a warm-up program before exercise and a cool-down program afterwards. Patients will be asked to do the exercises face to face with a physiotherapist 3 days a week. The first evaluations will be made on the day they come to the outpatient clinic for examination before surgery. Post-surgical evaluations will be made routinely after the exercise program is completed, when they are called by the physician for a check-up (6th week).

Researchers will compare the standard exercise group with the stabilization exercise group to see if pain, dysfunction, normal joint movement, proprioception, balance, muscular endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level) are different.

Detailed description: Patients who are decided to undergo cervical laminoplasty surgery, whose eligibility is determined according to the inclusion and exclusion criteria, and who voluntarily agree to participate in the study will sign an informed consent form before the study begins. After consent is obtained, patients will be divided into 2 groups, standard exercise group and stabilization exercise group, by computer-assisted randomization method. As a result of the randomization, the evaluator will not know which group the patients belong to. Evaluations for all groups; It will be carried out twice, on the day they come to the polyclinic for pre-surgical examination, and on the 6th week after the surgery, when they are routinely called by the physician for a check-up.

In the first evaluation, sociodemographic information (age, gender, height, weight, BMI, occupation, curriculum vitae, family history), health-related habits (smoking, alcohol, exercise habits), dominant upper and lower extremity will be questioned. Pain intensity (VAS), dysfunction (mJOA score), normal joint movement (digital inclinometer), proprioception (Laser Assisted Angle Repetition Test), balance (Computerized balance platform), kinesiophobia (Tampa Kinesiophobia Questionnaire), level of awareness (Neck Awareness Questionnaire) quality of life (SF-12), disability (Neck Disability Index), physical activity level (IPAQ-short form) and radiographic findings regarding to postural alignment will be evaluated. Radiographic findings of the patients will be interpreted according to the results obtained from routine control evaluations before and after surgery.

Patients included in the standard exercise group; warming up and cooling down program, posture exercises and neck exercises will be applied for 6 weeks. For patients in the stabilization exercise group, in addition to the practices in the standard exercise group, deep neck flexors training with stabilizers and dynamic stabilization exercises with elastic resistance band and elastic ball will be performed. Training with stabilizer will be applied for 6 weeks. Elastic resistance band exercises will be performed in the 4th week, and exercises with an elastic ball will be applied starting from the 6th week until the end of the exercise program. The 'standard exercise group' constitutes the control group of the study and the 'stabilization exercise group' constitutes the experimental group. Patients in both groups will be given cervical normal joint movement, posture and patient education on the day they will be discharged from the hospital. The first exercise session will also be held on the day you are discharged from the hospital. Patients who are not seen on the day of discharge from the hospital will start an exercise program as soon as possible (within the first week following discharge).

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of cervical pathologies identified by clinical symptoms and imaging
* Patients who are indicated to undergo cervical laminoplasty by a specialist in spine surgery
* Volunteering to participate in the study
* Becoming literate in Turkish

Exclusion Criteria:

* Having had previous spine surgery
* Having any neurological, cardiopulmonary, orthopedic, metabolic, vestibular problems that may affect evaluation and exercise application
* Malignancy or spinal tumor
* Spine infection
* Fracture or traumatic subluxation of cervical vertebrae after surgical procedure
* Severe axial or extremity pain after surgery, presence of hyperesthesia that makes activity difficult, or extremity paralysis
* Not attending 3 consecutive exercise sessions or participating less than 80% in the total exercise session

Primary outcomes:
measure: Pain intensity
timeFrame: Preoperative and postoperative 6th week (at the end of the exercise program)
measure: Dysfunction
timeFrame: Preoperative and postoperative 6th week (at the end of the exercise program)
measure: Joint Range of Motion
timeFrame: Preoperative and postoperative 6th week (at the end of the exercise program)
measure: Proprioception
timeFrame: Preoperative and postoperative 6th week (at the end of the exercise program)
measure: Balance
timeFrame: Preoperative and postoperative 6th week (at the end of the exercise program)
measure: Neck Extensor Muscle Endurance
timeFrame: Preoperative and postoperative 6th week (at the end of the exercise program)
measure: Neck Flexor Muscles Endurance
timeFrame: Preoperative and postoperative 6th week (at the end of the exercise program)
measure: Postural Alignment
timeFrame: Preoperative and postoperative 6th week (at the end of the exercise program)
Secondary outcomes:
measure: Kinesiophobia
timeFrame: Preoperative and postoperative 6th week (at the end of the exercise program)
measure: Neck Awareness
timeFrame: Preoperative and postoperative 6th week (at the end of the exercise program)
measure: Life Quality
timeFrame: Preoperative and postoperative 6th week (at the end of the exercise program)
measure: Disability
timeFrame: Preoperative and postoperative 6th week (at the end of the exercise program)
measure: Physical Activity Level
timeFrame: Preoperative and postoperative 6th week (at the end of the exercise program)
Other outcomes:
measure: Sociodemographic İnformation
timeFrame: Pre-surgery
measure: Sociodemographic İnformation BMI
timeFrame: Pre-surgery
measure: Health-related Habits
timeFrame: Pre-surgery
measure: Dominant Side
timeFrame: Pre-surgery
Locations:
city: İzmir
country: Turkey
facility: Izmir Katip Celebi University Ataturk Education and Research Hospital
Study officials:
affiliation: Izmir Katip Celebi University
name: Sevtap GUNAY UCURUM, Assoc. Dr.
role: STUDY_DIRECTOR
References: