Examining the Effectiveness of Exercise Training After Cervical Laminoplasty Surgery

NCT06279377 | Completed

• 1 other identifier: Katip Celebi University
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Spine Disease; Surgery; Rehabilitation; Exercise

Keywords

Cervical Laminoplasty; Exercise Training; Stabilization Exercises; Early Exercise

Outcome Measures

Primary Outcomes (8)

• Pain intensity

  Pain intensity will be assessed using the Visual Analogue Scale (VAS). While evaluating with VAS, patients will be asked to mark the degree of pain they feel on a 100 mm horizontal line.

  Preoperative and postoperative 6th week (at the end of the exercise program)

• Dysfunction

  It will be evaluated using the Modified Japanese Orthopedic Association (mJOA) Score, modified from the Japanese Orthopedic Association (JOA) score. It is a scale in which a total of 18 points can be obtained. Based on the mJOA score, 15-17 is defined as mild, 12-14 as moderate, and 0-11 as severe myelopathy. The recovery rate after surgery is calculated by the formula \[Healing rate (%) = \[(post-op JOA score - pre-op JOA score) / (18- pre-op JOA score)\] X 100\]. Recovery rate; \>75% is considered excellent, 50-75% is considered good, 25-50% is inadequate, and \<25% is considered poor.

  Preoperative and postoperative 6th week (at the end of the exercise program)

• Joint Range of Motion

  Active range of motion will be automatically calculated using the ACUMAR™ digital inclinometer. Cervical flexion, extension, right-left lateral flexion and right-left rotation movements of the patients will be evaluated.

  Preoperative and postoperative 6th week (at the end of the exercise program)

• Proprioception

  'Laser Assisted Angle Repetition Test', which is frequently used in the clinic, will be applied. The process will be repeated for cervical flexion, extension, right-left rotation and right-left lateral flexion. The error distance will be recorded and the tan value will be calculated.

  Preoperative and postoperative 6th week (at the end of the exercise program)

• Balance

  Balance assessment will be performed using a uniaxial force platform (ProKin 252, Tecnobody, Dalmine, Italy) with a sampling rate of 20 Hz and sensitivity of 0.1°. Static balance (eyes open and closed) and limit of stability will be evaluated.

  Preoperative and postoperative 6th week (at the end of the exercise program)

• Neck Extensor Muscle Endurance

  The digital inclinometer will be fixed to the lateral side of the head with velcro so that the screen of the device can be read. During the evaluation, patients will be asked to tuck their chin in and maintain the position by keeping their head in a horizontal alignment for as long as possible.

  Preoperative and postoperative 6th week (at the end of the exercise program)

• Neck Flexor Muscles Endurance

  During the test, the digital inclinometer will be fixed to the lateral side of the evaluator's head with velcro. Patients will be asked to lift their head approximately 2.5 cm (1 inch) off the bed by pulling their chin back and towards their chest (as if doing yes or no). Patients will be asked to maintain the position for as long as possible.

  Preoperative and postoperative 6th week (at the end of the exercise program)

• Postural Alignment

  Angular values obtained from routine radiographic findings of the patients will be calculated.

  Preoperative and postoperative 6th week (at the end of the exercise program)

Secondary Outcomes (5)

• Kinesiophobia

  Preoperative and postoperative 6th week (at the end of the exercise program)

• Neck Awareness

  Preoperative and postoperative 6th week (at the end of the exercise program)

• Life Quality

  Preoperative and postoperative 6th week (at the end of the exercise program)

• Disability

  Preoperative and postoperative 6th week (at the end of the exercise program)

• Physical Activity Level

  Preoperative and postoperative 6th week (at the end of the exercise program)

Other Outcomes (4)

• Sociodemographic İnformation

  Pre-surgery

• Sociodemographic İnformation BMI

  Pre-surgery

• Health-related Habits

  Pre-surgery

Study Arms (2)

Stabilization Exercise Group

EXPERIMENTAL

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.

Other: Stabilization Exercises

Standard Exercise Group

ACTIVE COMPARATOR

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.

Other: Standard Exercises

Interventions

Stabilization Exercises 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.

Also known as: Experimental Group

Stabilization Exercise Group

Standard Exercises 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.

Also known as: Active Comparator (Control) Group

Standard Exercise Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Celebi University Ataturk Education and Research Hospital

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Sevtap GUNAY UCURUM, Assoc. Dr.

  Izmir Katip Celebi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 28, 2024
• Study Start: May 5, 2023
• Primary Completion: June 30, 2025
• Study Completion: December 19, 2025
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)