Effect of Cervical Spinal Stabilization Exercise Programs by Magnetic Resonance Imaging in Healthy Individuals
2019年6月17日 更新者：Erdi Kayabınar、Hacettepe University
Investigation of Morphological Changes of Cervical Spinal Stabilization Exercise Programs Focused on Flexor and Extensor Muscles in Cervical Muscles by Magnetic Resonance Imaging in Healthy Individuals
The aim of this study was to investigate the morphological changes in the neck muscles of cervical spinal stabilization exercises focused on flexor and extensor muscles applied to healthy individuals.
調査の概要
詳細な説明
In the prevention and treatment of cervical region pathologies, various exercise methods are applied in the clinic.
The clinical exercises vary according to the time and severity of the pathology but also according to the pathology itself.
These exercises include exercises focusing on flexor or extensor muscles.
The aim of this study was to investigate the morphological changes in the neck muscles of cervical spinal stabilization exercises focused on flexor and extensor muscles applied to healthy individuals.
At least 27 healthy male subjects between the age of 18-30 are planned to be included in the study.
Individuals will be divided into 3 groups by simple randomization method.
In one group cervical stabilization exercise program focused on the flexor muscles will be applied and the other group cervical stabilization exercise program focused on the extensor muscles will be applied for 8 weeks.
Individuals in the control group will only be evaluated without exercise.
In the study, by using magnetic resonance imaging (MRI) method as the main evaluation, muscle anatomical cross-sectional area and T2 relaxation time measurements will be made and morphological changes in muscles will be determined.
These evaluation procedures will be performed on longus colli, sternocleidomastoid, semispinalis cervicis, multifidus and upper trapezius muscles.
As additional evaluation methods, muscle strength and muscle endurance tests, normal joint motion measurements, posture evaluation and MRI measurement of cervical spine curvature will be performed.
All evaluations will be performed at the beginning and at the end of these 8 weeks and the effects of the exercises applied on the muscles in the two groups will be examined.
研究の種類
介入
入学 (実際)
27
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Sıhhıye
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Ankara、Sıhhıye、七面鳥、06430
- Hacettepe University Faculty of Physical Therapy and Rehabilitation
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～30年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
男
説明
Inclusion Criteria:
- being healthy
- age between 18 to 30 years
- agree to participate in the study
Exclusion Criteria:
- to undergo any surgical procedure of the vertebral column
- inflammatory disease
- rheumatological disease
- history of malignancy
- congenital spinal cord anomaly
- congenital and/or spinal deformities
- radiculopathy
- myelopathy
- other neurological disorders
- vestibular disorders and/or trauma history
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Exercises focused on flexor muscles.
Flexor cervical stabilization exercises will be applied.
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Exercises emphasis flexor muscles.
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実験的：Exercises focused on extensor muscles.
Extensor cervical stabilization exercises will be applied.
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Exercises emphasis extensor muscles.
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介入なし：Control.
No intervention will be applied.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cervical muscles cross sectional area
時間枠：Change from baseline time at the end of 8 week
|
Measurement of the cross-sectional area of the examined muscles by axial mri images.
The circles of the muscles will be drawn by hand and examined with a computer program.
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Change from baseline time at the end of 8 week
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Cervical muscle T2 relaxation time
時間枠：change from baseline time at the end of 8 week
|
T2 relaxation time of circled muscles will be measured with milliseconds.
T2 axial and t2 mapping images will be obtained with mri.
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change from baseline time at the end of 8 week
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cervical muscle strength
時間枠：change from baseline score at the end of 8 week
|
The strength of the cervical flexor and extensor muscles and deltoid muscles will be measured by a digital hand dynamometer (Lafayette Instrument Company, USA).
The measurements of the dynamometer will be based on fine muscle test positions described by Lovett.
When measuring the muscle strength, resistance will be given from the frontal region for flexors and over the occipital region for the cervical extensors.
Resistance for deltoid muscles will be given around the shoulder.
The tests will be repeated three times and the highest of 3 repeated results obtained from these measurements will be recorded.
The strength of the muscles around the scapula will be evaluated with manual muscle test, which is rated at 0-5 points developed by Lovett.
5 point is maximum and 0 is the minimum point.
Statistical analyzes will be done with total muscle strength values.
A total of eight muscle muscle tests will be performed to evaluate the scapular muscles.
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change from baseline score at the end of 8 week
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New York posture rating chart
時間枠：change from baseline score at the end of 8 week
|
This evaluation system is scored by monitoring the posture changes that may occur in 13 different parts of the body.
Accordingly, if the person's posture is correct five points will be given.If impairment is moderate, three points will be given and if the impairment is severe, 0 point will be given.
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change from baseline score at the end of 8 week
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Tragus angle measurement
時間枠：change from baseline score at the end of 8 week
|
The evaluation of the tragus angle will be used as a result of the evaluation of the photograph taken in front of the checkered back surface with the computer program.
The Tragus, ear and C7 vertebrae will be marked and measured.
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change from baseline score at the end of 8 week
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Cervical flexor and extensor endurance test
時間枠：change from baseline score at the end of 8 week
|
The endurance evaluation of the deep cervical flexor muscles patients will be lied in the supine position, while the hands are in the free position on the abdomen, and the patient will be asked to remove the head slightly with the instruction.
A slight amount (30%) craniocervical flexion will be required after this position has been taught to the patient.
The time in which the patient maintains the position while maintaining the craniocervical flexion will be recorded in seconds.
In the evaluation of endurance of deep cervical extensor muscles, the individual will be asked to lie down from T6 level and the head and neck will droop from the bed.
The person will be instructed to bear the weight (4 kg in men) attached to a velcro placed over the ears in this position.
The test will begin with a slight amount of craniocervical flexion, as if the individual makes head up against weight, and the time the individual maintains this position will be measured in seconds.
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change from baseline score at the end of 8 week
|
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Cervical range of motion measurement
時間枠：change from baseline score at the end of 8 week
|
The Cervical Range of Motion (Performance Attainment Associates, St. Paul, MN, 55117, United States) (CROM 3) device will be used for the active evaluation of cervical range of motion.
Flexion-extension, rotation and lateral flexion measurements will be performed at appropriate positions.
The value found on the compass of the device will be recorded after each measurement.
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change from baseline score at the end of 8 week
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Evaluation of cervical spine curvature
時間枠：change from baseline score at the end of 8 week
|
In the evaluation of cervical spine curvature, measurements of Cobb angle will be used on images taken in sagittal plane with MRI.
|
change from baseline score at the end of 8 week
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Erdi Kayabınar, MSc、Hacettepe University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2019年2月25日
一次修了 (実際)
2019年5月2日
研究の完了 (実際)
2019年6月17日
試験登録日
最初に提出
2019年2月25日
QC基準を満たした最初の提出物
2019年2月25日
最初の投稿 (実際)
2019年2月27日
学習記録の更新
投稿された最後の更新 (実際)
2019年6月18日
QC基準を満たした最後の更新が送信されました
2019年6月17日
最終確認日
2019年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- KA-180136
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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米国FDA規制医薬品の研究
いいえ
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いいえ
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