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Cervical Spine DiseaseNCT06279377

Examining the Effectiveness of Exercise Training After Cervical Laminoplasty Surgery

A study testing Stabilization Exercises and Standard Exercises in people with Cervical Spine Disease and Surgery, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Cervical Spine Disease, Surgery, Rehabilitation
What is being tested?
Stabilization Exercises and Standard Exercises
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 May 2023to 19 Dec 2025
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Izmir Katip Celebi University Ataturk Education and Research Hospital

    Izmir

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Efficacy of Stabilization Exercise Training After Cervical Laminoplasty Surgery: A Randomized Controlled Study

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)?
Read more

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.

Read the 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).

Being tested
Stabilization Exercises, Standard Exercises
Keywords
Cervical Laminoplasty, Exercise Training, Stabilization Exercises, Early Exercise
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stabilization ExercisesOther

    Also called Experimental Group

    • 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 ExercisesOther

    Also called Active Comparator (Control) Group

    • 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.
Study groups in NCT06279377
Study groupRoleWhat they receive
Stabilization Exercise GroupExperimentalIn 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.
Receives: Other: Stabilization Exercises
Standard Exercise GroupActive comparatorOn 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.
Receives: Other: Standard Exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. Postural Alignment

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

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

Secondary outcomes (5)
  1. Kinesiophobia

    It will be evaluated with the 'Tampa Kinesiophobia Scale'. The person receives a total score between 17-68. A high score on the scale indicates that the person's fear of movement is also high. The person receives a total score between 17 and 68. A high score on the scale indicates that the person has a high fear of movement.

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

  2. Neck Awareness

    It will be evaluated with the Fremantle Neck Awareness Questionnaire. The total score of the survey is between 0-36. Higher scores indicate greater neck awareness.

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

  3. Life Quality

    SF-12 Quality of Life scale will be used for evaluation. While the physical component summary (PCS)-12 score is obtained from the subscales of general health, physical functionality, physical role and body pain, the mental component summary (MCS)-12 score is obtained from the social functionality, emotional role, mental health and energy subscales. . Both the PCS-12 and MCS-12 scores range from 0 to 100, with a higher score representing better health.

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

  4. Disability

    It will be evaluated with the Neck Disability Index. The patient's test score is determined according to certain score ranges: 0-4 (no disability), 5-14 (mild disability), 15-24 (moderate disability), 25-34 (severe disability), 35 and above (complete disability).

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

  5. Physical Activity Level

    It will be evaluated using the International Physical Activity Questionnaire. Calculation of the total score includes the sum of the duration (minutes) and frequency (days) of walking, moderate activity and vigorous activity. There are three levels of physical activity identified when classifying populations categorically: 'inactive', 'minimally active' and 'very active' (physical activity that enhances health).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start5 May 2023
  3. Primary completion30 Jun 2025
  4. Study completion19 Dec 2025

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06279377
Sponsor's protocol ID
Katip Celebi University
Status last verified
Apr 2026
First submitted
6 Feb 2024
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Stabilization Exercises and Standard Exercises in people with Cervical Spine Disease and Surgery, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).

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 4 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 20 Apr 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 Turkey (Türkiye). 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?

Pain intensity (time frame: Preoperative and postoperative 6th week (at the end of the exercise program)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 Apr 2026.

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