- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04136678
The Effect of Treadmill Back Walking Training on Balance and Function in Cerebral Palsy (CP)
The aim of this study was to investigate the effect of treadmill back walking training on balance and function in cerebral palsy.
In our study, scientific data will be prepared by clinical measurement tools in order to determine whether there is balance and walking effect of easy and practicable treadmill back walking training in the clinical setting in Cerebral Palsy.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Measurements will be made at baseline and after each 8 weeks of physiotherapy program, the results will be compared.
30 minutes of the physiotherapy session, which we will apply for 2 days and 45 minutes; in the prone, supine, crawling and above knee positions; They will take physiotherapy training based on neurodevelopmental therapy consisting of fine motor activities, standing up, weight transfer, stretching, strengthening and balance exercises with mat activities such as rotation, weight transfer, sitting.
- Term: After the first measurements, the participants will take 8 minutes, 2 days a week, the regular physiotherapy session based on 30 minutes Neurodevelopmental Therapy as described above, as well as 15 minutes conventional walking training, then the measurements will be repeated.
- Term: After the second measurements, the participants will take 8 weeks, 2 days a week, the regular physiotherapy session based on 30 minutes of Neurodevelopmental Therapy as described above, as well as 15 minutes of treadmill back walking training, then the measurements will be repeated.
- Term: After the third measurements, the participants will take 8 weeks, 2 days a week, the regular physiotherapy session based on the 30 minute Neurodevelopmental Therapy described above, as well as the 15-minute treadmill walking forward training, then the measurements will be repeated.
Statistical method (s) to be used: In the analysis of the results to be obtained in our study, SPS statistics 22.0 version of SPSS statistical package will be used under the Windows operating system Statistical Package for Social Sciences (SPSS). Descriptive statistical information will be shown as arithmetic mean ± Standard Deviation (x statistical ± Ss) or percentage (%) and the level of statistical significance will be considered as p≤0.05.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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İ̇stanbul, Turquie, (535) 020-6774
- Halkalı, Yükselen Başarı, Abı Hayat, Altın, Özlem and Çocuklarla Elele Education and Rehabilitation Center.
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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:
- Those who are between 6 and 18 years old and have a medical report on the diagnosis of cerebral palsy,
- Classes classified as Level I and II by Gross Motor Function Classification System (GMFCS),
- Lower extremity spasticity classified as 1st and 2nd degree according to Modified Modified Ashworth Scale,
- To understand and apply verbal commands and instructions.
- Volunteer to participate in the study,
- Read and approve the informed consent form.
Exclusion Criteria:
- Active epileptic seizures
- Those with visual or auditory defects,
- Those with fixed deformities in the lower extremities,
- Patients with a history of surgery in the lower extremity musculoskeletal system in the last 6 months
- Injection of Botulinum Toxin (BOTOX) for lower extremity within the last 6 months Spasticity drug users,
- Those with mental and cognitive problems will be excluded from the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: treadmill back walking training
15 minutes conventional walking training, 15 minutes of treadmill back walking training, 15-minute treadmill forward walking training
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15 minutes of conventional walking training 15 minutes of treadmill backward walking training 15 minutes of treadmil forward walking training
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The Pediatric Balance Scale
Délai: 8 weeks
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It can be considered as a simple, valid scale for studying functional balance capacity in children with spastic SP (Yi 2012).
Pediatric Berg Balance Scale (PBBS) will be used to evaluate the functional balance of daily living activities.
Higher scores mean a better outcome.
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8 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The Rivermead Visual Gait Assessment
Délai: 8 weeks
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RVGA allows rapid assessment and documentation of gait disturbances without equipment in the clinic and demonstration of clinical changes (Lord, et al. 1998).
Visual parameters of walking in our study will be evaluated by The Rivermead Visual Gait Assessment (RVGA).
Higher scores mean a worse outcome.
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8 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: H D Doğan, Pt, Istanbul Medipol University Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- halisdogan
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
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