Effect of Myofeedback and Neuromuscular Electrical Stimulation on Hemiplegic Children After Brain Tumor Resection
2026年5月17日 更新者：Amr Mohamed Sabry Lotfi Amer、Cairo University
This study was conducted to compare between the effect of neuromuscular electrical stimulation and myofeedback on upper limb function, muscle activity and brain derived neurotropic factor in blood for children with hemiplegia after brain tumor surgery.
調査の概要
状態
完了
条件
詳細な説明
Studies indicate that neuromuscular electrical stimulation is more effective than voluntary exercise in enhancing serum Brain-derived neurotrophic factor levels and improving muscle strength and mobility in children with conditions like cerebral palsy and spinal muscular atrophy.
Myofeedback, particularly surface electromyography biofeedback, is beneficial for upper extremity function post-stroke, as it helps raise awareness and control of movements.
Intensive electromyography biofeedback has shown significant recovery in hemiplegic children compared to traditional therapy.
There is potential for a multimodal treatment approach that combines neuromuscular electrical stimulation and biofeedback to mitigate the effects of brain tumors on upper limb function and optimize Brain-derived neurotrophic factor levels.
研究の種類
介入
入学 (実際)
45
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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Alexandria、エジプト
- Elmagd physical therapy centres, Teriaq oncology centre and Elite hospital.
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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
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age 6-14 years post brain tumor surgery children.
- Children's hand use experience questionnaire between 25 and 50 on a scale of units.
- Grade 2 muscle power of wrist, elbow and finger extensors.
- Outpatient children.
- Post-operative brain tumour, which is located in one of the two hemispheres.
- After 6 weeks post-surgery.
- The child can follow orders and instructions.
Exclusion Criteria:
- Blindness.
- Deaf child.
- Skin diseases.
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：selected physical therapy program
The control group will undergo a selected physical therapy (PT) program for one hour, three times weekly, over twelve weeks.
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The program includes push-up exercises, active strength training for wrist extensors using fine motor toys, stretching for wrist and elbow flexors and pronators, weight-bearing positions from side sitting, quadruped position with active limb elevation, rolling a small ball with the affected limb, and rhythmic muscle approximation for shoulder, elbow, and wrist.
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実験的：selected physical therapy program and biofeedback
Patient will undergo a selected physical therapy program for one hour, three times a week, for twelve weeks, supplemented by a biofeedback program.
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The program includes push-up exercises, active strength training for wrist extensors using fine motor toys, stretching for wrist and elbow flexors and pronators, weight-bearing positions from side sitting, quadruped position with active limb elevation, rolling a small ball with the affected limb, and rhythmic muscle approximation for shoulder, elbow, and wrist.
During sessions, the child sits with an arm resting on a table, with electrodes placed on the wrist extensors and forearm.
The treatment involves gradually increasing the intensity of faradic current to induce muscle contraction.
Each session lasts 30 minutes to one hour, with treatments up to three times daily, using a frequency of 50-100 Hz and a pulse duration of 0.1-1 ms, for a duration of 2 weeks to 3 months.
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実験的：selected physical therapy program and neuromuscular electric stimulation
The child will participate in a physical therapy program for one hour, three times a week, over twelve weeks, supplemented by neuromuscular electric stimulation.
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The program includes push-up exercises, active strength training for wrist extensors using fine motor toys, stretching for wrist and elbow flexors and pronators, weight-bearing positions from side sitting, quadruped position with active limb elevation, rolling a small ball with the affected limb, and rhythmic muscle approximation for shoulder, elbow, and wrist.
The child will participate in a physical therapy program for one hour, three times a week, over twelve weeks, supplemented by neuromuscular electric stimulation.
During sessions, the child sits with an arm resting on a table, with electrodes placed on the wrist extensors and forearm.
The treatment involves gradually increasing the intensity of faradic current to induce muscle contraction.
Each session lasts 30 minutes to one hour, with treatments up to three times daily, using a frequency of 50-100 Hz and a pulse duration of 0.1-1 ms, for a duration of 2 weeks to 3 months.
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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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Assessment of muscle activity
時間枠：at baseline and after 12 weeks
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All children will be assessed using surface electromyography for wrist extensor muscles while sitting, with their upper limbs resting on a desk and utilizing three electrodes.
The ground electrode (black) is placed proximal to the others, the active electrode (yellow) is on the common extensor origin, and the connector (blue) is positioned at least 3 cm distally.
After registering new patient data, the assessment begins via a one-channel surface electromyography setup, recording maximum and mean muscle activity during wrist extension upon pressing the play button.
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at baseline and after 12 weeks
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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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Assessment of upper limb function
時間枠：at baseline and after 12 weeks
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Using the short form of the Bruininks-Oseretsky Test, which includes fourteen selected test items, subtests 1, 2, 3, 4, and 7 are administered.
The child is positioned sitting at a table.
The time taken for each task is noted as part of the proficiency evaluation.
Performance is recorded, and raw scores are converted to point scores using a conversion table.
The better result from two trials for each item is taken, and the total points from the fourteen short items are recorded in the designated area.
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at baseline and after 12 weeks
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assessment of level of neurotrophic factor
時間枠：at baseline and after 12 weeks
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Fasting blood samples were taken in potassium-methylene diamine tetra acetic acid tubes, centrifuged for 15 minutes at 3000 rpm, and the plasma was stored at -80°C before being sent to Myriad RBM for a 190-analyte multiplex immunoassay.
Additionally, the Brain-derived neurotrophic factor enzyme-linked immunosorbent assay reliably measures whole blood Brain-derived neurotrophic factor with high reproducibility.
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at baseline and after 12 weeks
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assessment of dynamic spasticity of wrist and elbow flexors muscles
時間枠：at baseline and after 12 weeks
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Dynamic spasticity of wrist and elbow flexors muscles will be analyzed at the study's start and end.
Measurements will include resistance 1 (fast velocity movement through full range of motion to identify the point of catch), resistance 2 (passive range of motion), and the difference resistance 2-resistance 1 (dynamic spasticity component).
The Modified Ashworth Scale serves as a clinical tool for assessing spasticity, employing quantitative measurements at two speeds: slow (resistance 2) and fast (resistance 1).
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at baseline and after 12 weeks
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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。
スポンサー
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)
2024年7月1日
一次修了 (実際)
2025年6月1日
研究の完了 (実際)
2025年9月1日
試験登録日
最初に提出
2026年5月17日
QC基準を満たした最初の提出物
2026年5月17日
最初の投稿 (実際)
2026年5月26日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月26日
QC基準を満たした最後の更新が送信されました
2026年5月17日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Amr-phd
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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