Examining the Effectiveness of Exercise Training After Cervical Laminoplasty Surgery

NCT ID: NCT06279377

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-05
• Study Completion Date: 2026-03-15

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).

Conditions

Cervical Spine Disease; Surgery; Rehabilitation; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Stabilization Exercise Group

In the stabilization exercise group, in addition to those performed in the standard exercise group, training of deep neck flexor muscles with stabilizers and dynamic stabilization exercises will be applied.

Stabilizer Pressure Biofeedback unite, elastic resistance bands and elastic balls will be used in the stabilization exercise program.

Exercises performed with an elastic resistance band will be started in the 4th week, and exercises performed with an elastic ball will be started in the 6th week, depending on the suitability of the patient.

Group Type: EXPERIMENTAL

Stabilization Exercises

Intervention Type: OTHER

• Stabilizer Pressure Biofeedback device will be used in deep neck flexors training. Once the starting level is determined, training will be carried out with 2 mmHg pressure increases until the target value is 30 mmHg.
• During the exercises performed with the elastic resistance band, the patient will be asked to move the band with his hands (neck extension, right-left lateral flexion).
• During the exercises with the elastic ball, you will be asked to press your head on the ball at 90 degree angles (in 4 positions).
• Exercises will be performed in 10 repetitions by maintaining muscle contraction for 10 seconds. Exercises will be performed as 1 set of 10 repetitions or 2 sets of 10 repetitions, depending on the patient's tolerance. When 2 sets are completed successfully, the color of the elastic resistance band or the level of the exercise will be changed and continued.

Standard Exercise Group

On the day they will be discharged from the hospital, cervical normal joint movement, patient and posture training will be given.

Then the exercise program will begin and the first session will be held. Patients will be given a 5-minute warm-up program before starting the exercise and a 5-minute cool-down program at the end of the exercise.

Cervical flexion, extension, lateral flexion and rotation movements will be performed within the scope of the warm-up and cool-down program. Then, posture exercises and neck exercises with elastic resistance band will be performed.

Group Type: ACTIVE_COMPARATOR

Standard Exercises

Intervention Type: OTHER

• Cervical flexion, extension, lateral flexion and rotation movements will be performed within the scope of the warm-up and cool-down program. Cervical movements will be limited to approximately 30 degrees in the early period.
• As posture exercises, you will be asked to do scapular retraction and turning your shoulders forward and backward. In addition to these movements, pectoral stretching, anterior and posterior capsule stretching exercises will be performed.
• Elastic resistance bands will be used during neck exercises. Patients will be asked to perform cervical flexion, extension and right-left lateral flexion movements against the fixed band.
• Patients will be asked to continue each exercise for 10 seconds. Exercises will be performed as 1 set of 10 repetitions or 2 sets of 10 repetitions, depending on the patient's tolerance. When 2 sets are completed successfully, the elastic resistance band color will be changed and the exercise will progress.

Interventions

Stabilization Exercises

• Stabilizer Pressure Biofeedback device will be used in deep neck flexors training. Once the starting level is determined, training will be carried out with 2 mmHg pressure increases until the target value is 30 mmHg.
• During the exercises performed with the elastic resistance band, the patient will be asked to move the band with his hands (neck extension, right-left lateral flexion).
• During the exercises with the elastic ball, you will be asked to press your head on the ball at 90 degree angles (in 4 positions).
• Exercises will be performed in 10 repetitions by maintaining muscle contraction for 10 seconds. Exercises will be performed as 1 set of 10 repetitions or 2 sets of 10 repetitions, depending on the patient's tolerance. When 2 sets are completed successfully, the color of the elastic resistance band or the level of the exercise will be changed and continued.

Intervention Type: OTHER

Standard Exercises

• Cervical flexion, extension, lateral flexion and rotation movements will be performed within the scope of the warm-up and cool-down program. Cervical movements will be limited to approximately 30 degrees in the early period.
• As posture exercises, you will be asked to do scapular retraction and turning your shoulders forward and backward. In addition to these movements, pectoral stretching, anterior and posterior capsule stretching exercises will be performed.
• Elastic resistance bands will be used during neck exercises. Patients will be asked to perform cervical flexion, extension and right-left lateral flexion movements against the fixed band.
• Patients will be asked to continue each exercise for 10 seconds. Exercises will be performed as 1 set of 10 repetitions or 2 sets of 10 repetitions, depending on the patient's tolerance. When 2 sets are completed successfully, the elastic resistance band color will be changed and the exercise will progress.

Intervention Type: OTHER

Other Intervention Names

Experimental Group; Active Comparator (Control) Group

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Izmir Katip Celebi University

OTHER

Sponsor Role: lead

Responsible Party

Sevtap Günay

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sevtap GUNAY UCURUM, Assoc. Dr.

Role: STUDY_DIRECTOR

Izmir Katip Celebi University

Locations

Izmir Katip Celebi University Ataturk Education and Research Hospital

Izmir, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Sevtap GUNAY UCURUM, Assoc. Dr.

Role: CONTACT

sevtapgunay.tfd@gmail.com

0 505 356 97 70

Hilal UZUNLAR, MSc, RC

Role: CONTACT

hilalluzunlarr95@gmail.com

0 553 576 22 86

Facility Contacts

Hasan Kamil SUCU, Prof. Dr.

Role: primary

Other Identifiers

Katip Celebi University

Identifier Type: -

Identifier Source: org_study_id