- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07729800
Effects of Reflex Mediated Core Stability Exercise on Sensory Processing Skills and Gross Motor Function
Effects of Reflex Mediated Core Stability Exercise on Sensory Processing Skills and Gross Motor Function in Children With Cerebral Palsy
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
Reflex-mediated core stabilization, also known as dynamic neuromuscular stabilization (DNS). Dynamic Neuromuscular Stabilization (DNS) is a rehabilitation approach based on developmental kinesiology, which observes infant motor behavior from birth to walking. Proposed by Pavel Kolar, it emphasizes posture, breathing patterns, and joint centration, focusing on core stability provided by muscles such as the diaphragm, transverse abdominis, and multifidus. DNS aims to improve muscle strength and endurance by enhancing neuromuscular coordination and integrating the spinal stabilization system. Cerebral Palsy (CP) is a neurodevelopmental disorder affecting posture and mobility due to non-progressive brain lesions, often presenting with abnormal muscle tone, weakness, poor trunk control, and sensory, perceptual, communication, and cognitive issues. Sensory-processing disorders are frequently observed in children with CP. While traditional core stability exercises and sensory integration therapies have shown benefits, this study aims to specifically investigate the comprehensive impact of reflex-mediated core stability exercises (DNS) on both sensory processing skills and overall gross motor function in children with CP.
The study design will be Randomized Controlled Trial, conducted over 10 months at Sehat Medical Complex in Lahore. A total of 26 participants, with 13 in each group, will be recruited using non-probability convenient sampling. Inclusion criteria include children aged 4-12 years diagnosed with spastic-type CP (diplegic) classified within GMFCS Levels III-V who can follow simple verbal instructions, and whose legal guardian provides informed consent. Exclusion criteria encompass severe cognitive impairment, severe muscle contracture >10 degrees or bone deformity, and significant communication deficits. Data will be collected using the Sensory Profiling (SP) and Gross Motor Function Measure-88 (GMFM-88) tools. The experimental Group A will receive 30 minutes of reflex-mediated core stabilization exercises five times weekly, followed by 20 minutes of conventional therapy for 8 weeks. Group B, the control group, will receive conventional therapy. The synopsis will be presented to the Research Ethical Committee of Riphah International University, Lahore, for ethical approval to conduct this study. Data will be analyzed through SPSS version 27.0
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Lahore, Pakistan
- Sehat Medical Complex Hanjarwal
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
- Children with both genders.
- Children diagnosed with Cerebral Palsy (CP).
- Children aged between 4-12 years (12).
- Children with spastic-type Cerebral Palsy (diplegic) classified within Gross Motor Function Classification System (GMFCS) Levels III-V.
- Ability to understand and consistently follow simple verbal instructions.
- Informed written consent obtained from the child's legal parent or guardian.
Exclusion Criteria:
- Children with severe cognitive impairment.
- Severe muscle contracture >10 degrees or bone deformity significantly limiting participation in exercises.
- Children with significant Communication Deficits
- Any operational procedure within the last six months
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Reflex mediated core stability exercise
the exercises are progressed over the six weeks and include positions such as:
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The exercises are progressed over the six weeks and include positions such as:
Participants will be given 20 min of conventional therapy for 8 weeks, five times weekly. Therapy includes: Facilitatory techniques are used for gross motor control such as:
It also incorporates exercises like:
|
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Expérimental: conventional therapy
Participants will be given 20 min of conventional therapy for 8 weeks, five times weekly. Therapy includes: Facilitatory techniques are used for gross motor control such as:
It also incorporates exercises like:
|
Participants will be given 20 min of conventional therapy for 8 weeks, five times weekly. Therapy includes: Facilitatory techniques are used for gross motor control such as:
It also incorporates exercises like:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Sensory processing skills
Délai: baseline and after 6 weeks
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Sensory profiling was designed by an occupational therapist.
The questionnaire assessing the sensory processing of children aged 3-10 was filled out by their parents or caregivers.
It consisted of 125 items.
The survey consisted of 14 subsections under 3 main headings.
These main topics were sensory processing, modulation, and emotional behavioral responses.
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baseline and after 6 weeks
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Gross motor function
Délai: baseline and after 6 weeks
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The Gross Motor Function Measure (GMFM) is a tool that has been developed to assess change in gross motor function in children with cerebral palsy aged 5 months to 16 years of age.
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baseline and after 6 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Saifah Ashfaq, dpt, ripah international university
Publications et liens utiles
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
- REC/RCR&AHS/25/0705
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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