Spread And Effectiveness Of Botulinum Neurotoxin A In Spastic Equinus In Cerebral Palsy
SPREAD AND EFFECTIVENESS OF BOTULINUM NEUROTOXIN A IN SPASTIC EQUINUS IN CEREBRAL PALSY:SHORT-TERM STUDY
Objectives. To study the short-term neurophysiological and clinical outcome of botulinum toxin type A(BoNT-A), injected at standard doses, and assess toxin spread to neighboring uninjected muscles in children with cerebral palsy.
Subjects and methods. The investigators studied 18 ambulatory children with dynamic equinus foot deformity (mean age 6.1 years). The gastrocnemius muscle on the affected side was injected with BoNT-A (Dysport, range from 8.9-19.4 U/kg). As the primary neurophysiological outcome measure, compound muscle action potential (CMAP) areas were assessed in the lateral gastrocnemius (LG) and tibialis anterior(TA) muscles on the treated and untreated side before BoNT-A injections (T0), and on days 10 (T10), and 30 (T30) after injections. Clinical scales were assessed and video gait was analyzed at all three time points.
Results. In all patients, CMAP areas recorded from the LG and TA muscles on the treated side decreased significantly from pre-injection values at T10 (p<0.05) and T30 (p<0.002). Assessment at both time points after injections also showed that ankle spasticity had diminished (p<0.05), equinus foot excursion increased (p<0.05), and functional gait improved (p<0.05).
Conclusion. Although BoNT-A injected at standard doses improves gait in children with spastic equinus foot the toxin spreads to uninjected leg muscles. BoNT-A treatment for cerebral palsy therefore needs individualizing according to the child's clinical features.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 4
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- spasticity refractory to oral medication
- patients able to walk independently or with aid
- no contraindications to BoNT-A treatment such as fixed contracture,aminoglycoside therapy and myasthenia gravis and no other neuromuscular diseases
- no orthopedic surgery before
- normal or mildly declined cognition
- previous treatment at least six months before the study
Exclusion Criteria:
- all contraindications to BoNT-A treatment
研究計画
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：非ランダム化
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：botulinum toxin A
botulinum toxin A diffusion in cerebral palsy
|
BoNT-A (Dysport, Ipsen) ,into the medial gastrocnemius (MG) and LG muscles unilaterally on the affected spastic hemiplegic side; dose mean± SE, 283.3± 24.7 U.. The mean dose/kg injected was 14.4± 0.8, range from 8.5 to 20 U/kg, diluted in 2.5 ml saline.
frequency: once.
他の名前：
|
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 |
|---|---|---|
|
BoNT-A injected into gastrocnemius within standard dose ranges spreads to surrounding anterior lower-limb muscles in children with CP and induces chemodenervation in injected muscles
時間枠：one month
|
As the primary neurophysiological outcome measure of BoNT-A induced paresis and spread, we studied changes in compound muscle action potential (CMAP) areas recorded from the lateral gastrocnemius (LG) muscle after injecting BoNT-A and from the ipsilateral tibialis anterior (TA) muscle in children with spastic hemiplegia.
In line with others we considered a decreased CMAP area from LG muscle injected with BoNT-A as the neurophysiological index of BoNT-A-induced paresis
|
one month
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
the short-term clinical effect of BoNT-A injected within standard dose ranges on changes in gait in children with CP
時間枠：30 days
|
As the clinical outcome measures clinical scales were assessed and video gait was analyzed before BoNT-A injections (T0), and on days 10 (T10), and 30 (T30) after injections.
|
30 days
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：laura bertolasi, md、Universita di Verona
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
- BoNT-A-botulinum neurotoxin type A
- CMAP-compound muscle action potential
- CP-cerebral palsy
- LG-lateral gastrocnemius
- MG-medial gastrocnemius
- TA-tibialis anterior
- PROMS-passive range of movement
- MAS-modified Ashworth scale
- EVGS-Edinburgh visual gait scale
- GMF-CS-gross motor function classification system
追加の関連 MeSH 用語
その他の研究ID番号
- CE1780
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。
Botulinum Toxin Type Aの臨床試験
-
University of NebraskaInCor Heart Institute; VU University of Amsterdam完了