- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07935967
Continuous Passive Motion on Upper Limb Spasticity and Hand Function in Children With Hemiplegic Cerebral Palsy (CPMCP)
Effect of Continuous Passive Movement on Upper Limb Spasticity and Hand Function in Children With Hemiplegia
The goal of this clinical trial is to evaluate the effect of Continuous passive motion (CPM) on upper limb spasticity and hand function in children with hemiplegic cerebral palsy.
The main questions it aims to answer are:
Does continuous passive motion (CPM) have an effect on upper limb spasticity and hand function in children with hemiplegic cerebral palsy?
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Cerebral palsy (CP) is a common underlying factor contributing to motor impairment in children. CP has frequently changed over the years. The most recent definition of CP is a collection of lasting irregularities in the development of movement and body positioning that result in activity restrictions for the affected person (Sadowska et al.,2020).
Hemiplegia is a neurological disorder that is frequently detected in children with CP. It may provoke altered selective motor control, weakness, and spasticity. While one side is affected by the disorder, the contralateral side appears to maintain complete functionality. The consequent asymmetry has been proven to affect many daily-life tasks, such as walking (DiNardo et al., 2019).
To date, little research examined the effect of Continuous passive motion (CPM) on functional impairment for upper extremity in CP children with hemiplegia. In addition to the economic changes in our society and increase of the cost of physical therapy session push us to investigate the immediate effect of physical therapy techniques and modalities and determine its validity in order to decrease physical therapy period and cost and improve its effectiveness.
Thus, outcomes of this study will be beneficial to determine the effect of CPM may be effective in the treatment of upper extremity in children with hemiplegia.
Statement of the problem:
Does continuous passive motion (CPM) have an effect on upper limb spasticity and hand function in children with hemiplegic cerebral palsy?
Purpose of the study:
The Purpose of the study was:
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To evaluate the effect of Continuous passive motion (CPM) on upper limb spasticity in children with hemiplegic cerebral palsy.
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To evaluate hand function in children with hemiplegic cerebral palsy. The selected subjects will be divided randomly by sealed envelopes into two groups of equal number; thirty children for each group. Participants received 1 hour and 30 minutes per day, 3 days/week for 3 month.
- Study group :
Children of this group will receive specially designed physical therapy program and occupational therapy program in addition to continuous passive movement for the affected upper limb.
-control group : Children of this group will receive only specially designed physical therapy program and occupational therapy program.
Inclusive criteria:
The subjects will be included if:
- Their age will be ranged from 9-12 years.
- They are diagnosed with hemiplegic cerebral palsy.
- The degree of spasticity; grade 2 according to modified Ashworth scale (Bohanon and Smith, 1987). (Appendix I)
- Manual ability to handle objects in daily activities will be at level III according to Manual Ability Classification System (MACS) (Eliasson et al., 2006). (Appendix II)
- They will be able to understand orders given to them.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Eman Fathy Mohamed, Doctoral Degree
- Numéro de téléphone: +201124424650
- E-mail: doctoreman.fathy123@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Gehan Hassan El-Meniawy, Professor
- Numéro de téléphone: +201111801114
- E-mail: ggelmeniawy@Gmail.com
Lieux d'étude
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-
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Giza, Egypte
- Faculty of physical therapy Dokki,Giza Egypt
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- The subjects will be included if:
- Their age will be ranged from 9 -12 years.
- They are diagnosed with hemiplegic cerebral palsy.
- The degree of spasticity; grade 2 according to modified Ashworth scale (Bohanon and Smith, 1987). (Appendix I)
- Manual ability to handle objects in daily activities will be at level III according to Manual Ability Classification System (MACS) (Eliasson et al., 2006). (Appendix II)
- They will be able to understand orders given to them.
Exclusion Criteria:
- The subjects will be excluded if they:
- fixed deformities in the spine and/or upper extremities or suffering from Seizures.
- visual nor auditory problems.
- perceptual or cognitive problems.
- injected by BOTOX in deltoid or biceps brachii muscles at the last 6 months
- have surgical interference in upper limbs and/or spine at the last year.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: study group
-Study group: Children will receive specially designed physical therapy program + occupational therapy program in addition to continuous passive movement (CPM) for the affected upper limb. 1.5 hours/day, 3 days/week for 3 months. |
|
|
Comparateur actif: Control group
Children will receive only the specially designed physical therapy program + occupational therapy program 1.5 hours/day, 3 days/week for 3 months. |
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hand functions
Délai: 45-60 minutes
|
Hand functions as manual dexterity, fine motor precision and fine motor integration will be assessed using Bruininks- Oseretsky Test of Motor Proficiency 2nd Edition |
45-60 minutes
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Spasticity of upper limb
Délai: 10 minutes
|
Spasticity will be assessed using electromyographic apparatus (H/M ratio ) |
10 minutes
|
|
strength of biceps and deltoid
Délai: 15 minutes
|
Lafayette (hand held dynamometer) |
15 minutes
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Eman Fathy Mohamed, dectoral degree, El salam university
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- P.T.REC/012/005697
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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