Sensitivity of an Upper Limb Motion Analysis Protocol to Changes in Kinematics and Muscle Activity After Constraint Induced Therapy in Children With Hemiplegia (MouvsupTCIHemi)
2019年6月7日 更新者：Nantes University Hospital
Quantified Analysis of the Movements of the Upper Limb of Children With Hemiparesis Participating in the Stress Induced Therapy Program
In France, Cerebral Palsy (CP) affects 1 in 450 births.
It results from lesions of the brain, before, during, or shortly after birth.
These non-progressive lesions cause muscle impairments, responsible for activity limitations.
These muscle impairments include muscle stiffness, and muscle weakness.
Children with Unilateral CP (UCP) have these impairments on only one side of the body.
To compensate for activity limitations with their impaired arm, these children over-use their non-impaired arm.
The objective of constraint-induced therapy (CIT) is to minimize this asymmetry which deteriorates mobility on the impaired side, by forcing the child to only use its impaired arm several hours a day during several weeks of therapy.
It is known using clinical tests that this therapy improves the overall motor function of the impaired arm.
However, the underlying mechanisms are yet unknown.
An understanding of these mechanisms would suggest ways to maximize the effectiveness of this therapy, which requires a significant commitment from the child and its family.
The investigaors propose in this project a quantitative and objective evaluation of the effect of CIT on the movements of the impaired arm of children with UCP.
The investogators focus their analysis on muscle activation, to assess which aspect of muscle impairments is modified by CIT.
To this end, the investigators will use sensors identical to those already used in clinics for the Quantified Gait Analysis of children with CP, recognized since 2006 by the Haute Autorité de Santé as providing key supplementary data in the evaluation of complex gait disorders.
Results from this study will provide leads to optimize CIT.
Some children could for example benefit from CIT paired with treatments to reduce muscle stiffness or to strengthen muscles
調査の概要
状態
完了
条件
詳細な説明
Quantitative and objective evaluation of upper limb movements will take place in a motion analysis laboratory and will take place as follow:
- A clinical exam of the participant will be performed by the physician to collect maximal passive joint amplitudes with a goniometer and anatomical measures (length, circumference) of the upper limb.
- The participant will be equipped with surface electromyographic electrodes to measure the activation of his superficial muscles, and with retroreflective markers placed on anatomical landmarks of his thorax, shoulder, and arm, to measure upper limb kinematics with a 3D motion capture system composed of 8 VICON cameras.
- Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer.
The participant will be placed on a height adjustable bench, in the center of the laboratory. He will be asked to perform upper limb movements:
- A few movements not measured, to familiarize with the equipment;
- Recorded movements: a trial is composed of a few consecutive cycles of a movement such as elbow flexion-extension. A trial usually last about 10seconds. A few seconds-time of rest is imposed between each trial. The required movements are the following: elbow flexion-extension, elbow pronosupination, and "hand to mouth".
- Finally, the participant will be asked to lie down on an exam table and to rest relax, in order to measure the electromyographic signal of his muscles at rest.
Duration of the protocol is about 1h30, with less than 30seconds of effort, and a few minutes of performing simple upper limb movements.
研究の種類
介入
入学 (実際)
28
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
-
-
-
Nantes、フランス、46208
- CHU de Nantes
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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
6年～17年 (子)
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
全て
説明
Inclusion Criteria:
- Participants (excluding healthy volunteers) must have hemiparesis.
- Children must be between 6 and 17 years of age. The protocol requires a minimum concentration difficult to obtain for children under 6 years.
- Participants must be enrolled in a health insurance plan.
Exclusion Criteria:
- Inability to understand or follow instructions during 1h30.
- Physical incapacity to carry out the requested movements
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：他の
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：A: Healthy volunteers
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Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer.
|
|
他の：B: Patient with heamiplegia
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Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer.
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他の：C: Patient with heamiplegia and constraint induced therapy
arm with constraint induced therapy (done before the protocol)
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Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer.
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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 |
|---|---|---|
|
Upper limb muscle activation envelopes
時間枠：5 weeks
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Muscle activation envelopes come from electromyographic signals of upper limb muscles.
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5 weeks
|
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kinematics during active movements
時間枠：5 weeks
|
Kinematics: angles, velocities, accelerations of the thorax, shoulder, elbow and wrist in the three anatomical plans (sagittal, frontal, transverse).
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5 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。
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)
2017年3月28日
一次修了 (実際)
2019年4月17日
研究の完了 (実際)
2019年4月17日
試験登録日
最初に提出
2017年3月20日
QC基準を満たした最初の提出物
2017年3月28日
最初の投稿 (実際)
2017年4月4日
学習記録の更新
投稿された最後の更新 (実際)
2019年6月10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7日
最終確認日
2019年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。