産科の上腕神経叢損傷のある子供の段階的な運動画像トレーニングの有効性の調査
2026年8月31日 更新者:Hüseyin MAHİROĞLU、Izmir Bakircay University
上肢機能、固有受容、機能的機動性、バランス、産科の上腕神経叢損傷のある生活の質に及ぼす段階的な運動画像トレーニングの有効性の調査
この研究の目的は、従来の治療に加えて産科の上腕神経叢損傷を伴う患者の上肢運動機能、固有受容、機能的機動性、バランス、および生活の質に対する段階的な運動画像トレーニングの影響を調査することです。
これに関連して、私たちの目的は、中枢神経系のレベルで発生することが示されている運動計画の欠陥に対処するための新しい理学療法アプローチを特定することです。
調査の概要
詳細な説明
この研究は、無作為化された制御された単一盲検試験として計画されました。
この研究の目的は、上肢の運動機能、固有受容、機能的機動性、および生活の質に加えて、産科の上腕神経叢損傷を伴う患者の従来の治療に加えて行われる、段階的な運動画像(GMI)トレーニングの影響を調査することでした。
最初の評価と並行して、子供の機能状態と重症度に応じて個別化される従来の理学療法プログラムが作成されました。
GMIプログラムでは、このプログラムに加えて、GMIトレーニングのコンポーネントが適用され、皮質モーターネットワークを連続的にアクティブにし、皮質組織を開発します。
治療の前後に参加者のすべての評価は、盲目的な理学療法士によって行われます。
研究の種類
介入
入学 (実際)
42
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
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Menemen
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Izmir、Menemen、トルコ(Türkiye)、35400
- Izmir Bakircay University Physiotherapy and Rehabilitation Application and Research Center
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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
- 子
- 大人
健康ボランティアの受け入れ
いいえ
説明
包含基準:
- 家族の同意と子供の意欲を得る
- 7〜18歳の間にある
- 産科上腕神経叢損傷と診断されています
- 過去6か月間は理学療法を受けていません
除外基準:
- 外傷性(出生後)上腕神経叢損傷がある
- 過去6か月以内に上腕神経叢損傷に関連する合併症の手術を受けた(放出、腱の移動、骨切り術など)
- OBPIに加えて、別の神経学的、神経筋、筋骨格、または心肺系病を起こす
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:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ:Conventional Physiotherapy Group
Participants in the control group received a standardized conventional physiotherapy program for 45 minutes, twice weekly for 8 weeks.
The program included upper extremity range of motion exercises, selective strengthening, stretching, sensory-motor stimulation, functional activities, trunk stabilization, balance exercises and a home exercise program.
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The conventional physiotherapy program was delivered for 45 minutes per session, twice weekly for 8 weeks.
The program was individualized according to the child's age, functional level, cooperation, severity and type of involvement.
It included passive, active-assisted and active range of motion exercises for the shoulder, elbow, forearm, wrist and fingers; selective strengthening exercises for scapulothoracic and upper extremity muscles; stretching of shortened muscles and soft tissues using static manual and PNF techniques when indicated; age-appropriate functional upper extremity activities such as reaching, grasping, releasing, carrying, bimanual tasks and activities of daily living; sensory-motor stimulation activities; trunk mobility and stabilization exercises; static and dynamic balance exercises; and a home exercise program.
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実験的:Graded Motor Imagery Group
Participants in the study group received a graded motor imagery program in addition to the same conventional physiotherapy program.
The graded motor imagery program was applied for 15 minutes per session, twice weekly for 8 weeks, and included lateralization training, explicit motor imagery training and mirror therapy.
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The graded motor imagery program was applied in addition to conventional physiotherapy for 15 minutes per session, twice weekly for 8 weeks.
The program consisted of three sequential phases.
During weeks 0-2, lateralization training was performed using Recognise™ Hand and Recognise™ Shoulder applications.
During weeks 2-6, explicit motor imagery training was applied according to PETTLEP principles, progressing from simple upper extremity movements to individualized functional and participation-based activities.
During weeks 6-8, mirror therapy was performed, progressing from distal hand and wrist movements to proximal, reaching and functional upper extremity tasks.
Participants were instructed to focus on the visual or imagined movement without actual movement during imagery tasks and to perceive the mirror reflection as movement of the affected extremity during mirror therapy.
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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 |
|---|---|---|
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The Modified Mallet Classification System
時間枠:Baseline and immediately after the 8-week intervention.
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The Modified Mallet Classification is a valid and reliable scale frequently used in the literature to determine the functional status of the upper extremity in individuals with brachial plexus injuries.
Rather than assessing the functions of individual muscles, this classification system evaluates the global functional characteristics of the affected upper extremity.
It assesses five movements: global abduction, global external rotation, hand-to-neck, hand-to-mouth, and hand-to-spine.
Each movement is scored from 1 to 5 according to the position achieved and the quality of movement.
The total score ranges from 5 to 25, with higher scores indicating better upper extremity function.
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Baseline and immediately after the 8-week intervention.
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Active Movement Scale
時間枠:Baseline and after 8 weeks of intervention
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The Active Movement Scale was developed by the Brachial Plexus Clinic at The Hospital for Sick Children in Toronto.
In children with obstetric brachial plexus injury, the affected upper extremity is evaluated across 15 joint movements extending from the shoulder to the fingers.
Each movement is initially assessed with gravity eliminated.
If full movement is achieved in the gravity-eliminated position, the movement is subsequently evaluated against gravity.
Each movement is scored separately from 0 to 7, with higher scores indicating better active movement performance.
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Baseline and after 8 weeks of intervention
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Range of Motion Measurement
時間枠:Baseline and after 8 weeks of intervention
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Range of motion (ROM) was assessed using a universal goniometer to identify movement limitations in the upper-extremity joints.
Measurements were performed according to standard goniometric measurement principles and recorded in degrees.
Active range of motion of the shoulder, elbow, forearm, and wrist joints of the affected upper extremity was evaluated.
The assessed movements included shoulder flexion, extension, abduction, internal rotation, and external rotation; elbow flexion and extension; forearm supination and pronation; and wrist flexion and extension.
During the assessment, the participants' starting positions and the placement of the goniometer axis, stationary arm, and moving arm were standardized according to established measurement procedures.
Care was taken to prevent compensatory movements originating from the trunk, scapula, shoulder, and forearm.
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Baseline and after 8 weeks of intervention
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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 |
|---|---|---|
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Movement Imagery Questionnaire for Children
時間枠:Baseline and after 8 weeks of intervention
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The Movement Imagery Questionnaire for Children was used to assess the child's motor imagery ability.
The questionnaire evaluates the ability to mentally imagine movements using three imagery modalities: internal visual imagery, external visual imagery and kinesthetic imagery.
The child is asked to imagine specific movements and then rate how easy or difficult the imagery experience was.
Each item is scored on a 7-point scale, where lower scores indicate more difficult imagery and higher scores indicate easier and better imagery ability.
Subscale scores are calculated for internal visual imagery, external visual imagery and kinesthetic imagery.
Higher subscale and total scores indicate better motor imagery ability.
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Baseline and after 8 weeks of intervention
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Kinesthetic and Visual Imagery Questionnaire-20
時間枠:Baseline and after 8 weeks of intervention
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The Kinesthetic and Visual Imagery Questionnaire-20 was used to evaluate visual and kinesthetic motor imagery ability.
Participants are asked to perform or assume specific movement positions and then mentally imagine the same movement.
For each item, the clarity of the visual image and the intensity of the kinesthetic sensation are rated separately.
Visual imagery is scored according to how clear the imagined image is, and kinesthetic imagery is scored according to how strongly the movement sensation is felt.
Each item is scored on a 5-point scale.
Higher visual imagery scores indicate clearer mental images, and higher kinesthetic imagery scores indicate stronger kinesthetic sensations.
Higher total scores indicate better motor imagery ability.
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Baseline and after 8 weeks of intervention
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Raimondi Hand Score
時間枠:Baseline and after 8 weeks of intervention
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Raimondi Hand Score was used to evaluate hand function of the affected upper extremity.
The classification assesses functional hand use, including grasp ability, finger flexion and extension, wrist movement, thumb use and forearm rotation.
The score ranges from 0 to 5. A score of 0 indicates complete paralysis or absence of grasp, while higher scores indicate progressively better hand and finger function.
A score of 5 represents strong finger flexion and extension, full pronation and supination, and good use of the thumb and intrinsic hand muscles.
Higher scores indicate better hand function.
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Baseline and after 8 weeks of intervention
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Gilbert-Raimondi score for elbow function
時間枠:Baseline and after 8 weeks of intervention
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Gilbert-Raimondi Elbow Function Scale was used to assess elbow movements.
The scale comprises three components: the degree of active elbow flexion achieved, elbow extension strength, and extension deficit.
During the assessment, elbow flexion and extension movements were explained to the participant, who was then instructed to perform them actively.
The elbow extension deficit was also measured in degrees.
Flexion was scored as 1 when there was no movement or only muscle contraction, 2 for incomplete movement, and 3 for complete movement.
Extension was scored as 0 when no movement was present, 1 when extension was weak, and 2 when it was good.
The extension deficit was scored as 0 for 0-30°, -1 for 30-50°, and -2 for deficits greater than 50°.
Based on the total score, elbow function was classified as poor for scores of 0-1, moderate for scores of 2-3, and good for scores of 4-5.
Higher scores indicate better elbow function.
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Baseline and after 8 weeks of intervention
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Gilbert Shoulder Scale
時間枠:Baseline and after 8 weeks of intervention
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Gilbert Shoulder Function Rating System was used to assess shoulder function and the degree of recovery of shoulder movements in participants with obstetric brachial plexus injury (OBPI).
This system grades shoulder function based on shoulder abduction and active external rotation.
During the assessment, participants were instructed to actively perform shoulder abduction and external rotation.
Scores ranged from 0 to 5 based on the degree of shoulder abduction and active external rotation, with higher scores indicating better shoulder function.
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Baseline and after 8 weeks of intervention
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The Quality of Upper Extremity Skills Test (QUEST)
時間枠:Baseline and after 8 weeks of intervention
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The Quality of Upper Extremity Skills Test (QUEST) is a performance-based assessment tool developed to evaluate the quality of upper-extremity movement and manual skills in children.
During the assessment, participants were observed in accordance with the standardized test instructions.
Dissociated and controlled movement skills were assessed in the dissociated movements domain; the ability to grasp and release objects in the grasp domain; the capacity to bear weight through the upper extremity in the weight-bearing domain; and protective upper-extremity responses to loss of balance or postural changes in the protective extension domain.
Scoring was performed according to the formulas and standardized instructions provided in the scoring manual.
Each domain score and the overall QUEST score range from 0 to 100, with higher scores indicating better quality of upper-extremity movement and functional ability.
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Baseline and after 8 weeks of intervention
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Box and Block Test
時間枠:Baseline and after 8 weeks of intervention
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The Box and Block Test was used to assess gross manual dexterity and functional hand performance.
The test was administered using a standard box divided into two compartments by a partition and equally sized wooden blocks.
During the assessment, the participant was seated at a table, and the box was positioned so that the compartment containing the blocks was on the side of the extremity being tested.
Before the test, the instructions were explained to the participant, and a brief practice trial was provided to ensure comprehension.
The participant was then instructed to transfer the blocks one at a time from one compartment to the other as quickly as possible for 60 seconds.
At the end of the test, the number of blocks transferred to the opposite compartment was recorded.
A higher score indicated better gross manual dexterity and functional performance of the upper extremity.
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Baseline and after 8 weeks of intervention
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Hand Grip Strength
時間枠:Baseline and after 8 weeks of intervention
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Handgrip strength was assessed using a Jamar hydraulic hand dynamometer.
Measurements were performed in the standard testing position recommended by the American Society of Hand Therapists.
Participants were seated with their hips and knees flexed to approximately 90°, the shoulder adducted, the forearm in a neutral position, the elbow flexed to 90°, and the wrist positioned at 0-30° of extension.
Participants were instructed to grip the dynamometer and squeeze with their maximum possible force and were verbally encouraged during each measurement.
Three measurements were performed for the affected upper extremity, with brief rest intervals between trials.
The mean of the three measurements was calculated and recorded in kilograms.
Higher values indicate greater handgrip strength.
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Baseline and after 8 weeks of intervention
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T-Shirt Donning and Doffing Test
時間枠:Baseline and after 8 weeks of intervention
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The T-Shirt Donning and Doffing Test was administered to assess upper-extremity functional performance and movement ability during activities of daily living.
The test was performed using a standard T-shirt, with the participant standing 30 cm behind a table.
Upon receiving the command, the participant was instructed to put on the T-shirt, take it off, and place it back on the table.
The test ended when the removed T-shirt touched the table, and the elapsed time was recorded in seconds.
The test was repeated three times, and the mean of the three trials was used in the analysis.
A shorter completion time indicates better upper-extremity functional performance.
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Baseline and after 8 weeks of intervention
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Proprioception Assessment
時間枠:Baseline and after 8 weeks of intervention
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Proprioceptive accuracy was assessed at the shoulder and elbow using an active joint position reproduction test with a digital inclinometer.
During testing, the participant's vision was occluded.
For shoulder abduction, the examiner passively moved the affected arm from the 0° starting position to the target angles of 60° and 90°.
Each target position was maintained for 5 seconds to allow the participant to perceive and learn the position, after which the arm was returned to the starting position.
The participant was then asked to actively reproduce the target angle.
The same procedure was performed for elbow flexion at target angles of 60°, and 90°.
Three trials were completed at each target angle.
The absolute angular error between the target angle and the actively reproduced angle was calculated for each trial, and the mean of the three trials was recorded in degrees.
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Baseline and after 8 weeks of intervention
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Timed Up and Go Test
時間枠:Baseline and after 8 weeks of intervention
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The Timed Up and Go Test is a simple, practical, and rapid performance-based test used to assess functional mobility and dynamic balance.
The child is instructed to stand up from a standard chair with a backrest and armrests, walk a predetermined distance of 3 meters as quickly and safely as possible without running, turn around without touching or receiving support from any object, walk back to the chair, and return to a seated position.
The time required to complete the test is recorded in seconds.
Lower completion times indicate better functional mobility and dynamic balance.
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Baseline and after 8 weeks of intervention
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Timed Up and Down Stairs Test
時間枠:Baseline and after 8 weeks of intervention
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The Timed Up and Down Stairs Test is a valid and reliable performance-based test used to assess functional mobility and dynamic balance.
The test begins with the child standing 30 cm from the bottom of a 10-step staircase.
On command, the child is instructed to ascend the stairs as quickly and safely as possible, turn around immediately after reaching the top step without pausing, and descend the stairs.
Timing begins with the command to start and ends when the child steps off the lowest step and places both feet on the floor.
The time required to complete the test is recorded in seconds.
Lower completion times indicate better functional mobility and dynamic balance.
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Baseline and after 8 weeks of intervention
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Functional Reach Test
時間枠:Baseline and after 8 weeks of intervention
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The Functional Reach Test is an easily administered, performance-based assessment used to evaluate dynamic balance and postural stability.
It measures the maximum distance an individual can reach forward in the horizontal plane while maintaining a fixed base of support in standing.
The participant stands beside, but does not touch, the measurement surface and raises the arm to 90° of shoulder flexion.
The initial position of the tip of the third finger is recorded.
The participant is then instructed to reach forward as far as possible without moving the feet, taking a step, touching the measurement surface, or losing balance.
The final position of the tip of the third finger is recorded.
The functional reach distance is calculated as the difference between the initial and final positions and is reported in centimeters.
Greater distances indicate better dynamic balance and postural stability.
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Baseline and after 8 weeks of intervention
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Quality of Life Assesment
時間枠:Baseline and after 8 weeks of intervention
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PedsQL 4.0 was used to assess the participants' health-related quality of life.
The scale consists of 23 items and evaluates four core domains: physical functioning, emotional functioning, social functioning, and school functioning.
Subscale scores are calculated by averaging the corresponding item scores, whereas the total scale score is calculated by averaging all item scores.
Items are rated on a 5-point Likert scale and reverse-scored and linearly transformed to a 0-100 scale.
Higher scores indicate better health-related quality of life.
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Baseline and after 8 weeks of intervention
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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。
捜査官
- スタディディレクター:Gulbin Ergin, Professor、Izmir Bakircay 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)
2023年11月11日
一次修了 (実際)
2026年6月20日
研究の完了 (実際)
2026年6月20日
試験登録日
最初に提出
2025年5月4日
QC基準を満たした最初の提出物
2025年5月4日
最初の投稿 (実際)
2025年5月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月2日
QC基準を満たした最後の更新が送信されました
2026年8月31日
最終確認日
2026年8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
- BakircayU-FTR-HM-01
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
IPD プランの説明
データ収集の後、データに関連する長期フォローアップを含む別の調査が将来計画されています。
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いいえ
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