- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07579000
SPARK Exercise Program and Game-based Training in Children With Autism Spectrum Disorder
Comparative Effects of Structured Sport, Play and Active Recreation for Kid Exercise Program and Game-based Training on Motor Proficiency and Social Interaction in Children With Autism Spectrum Disorder
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Children with Autism Spectrum Disorder (ASD) often faces difficulties to perform motor skills and in social interactions which can affect their daily functioning and quality of life.
Motor difficulties such as poor coordination, balance deficits, delayed gross and fine motor skills mostly coexists with social communication impairments which can create a barrier to participate in physical activities and interaction with friends and family. Previous researches shows that structured physical activities can help to cop up with these difficulties. The aim of this experimental study to compare the effects of (SPARK) which is evidence-based exercise program to enhance the motor skills through skill-based activities while also focusing on social engagement through group play and Game-based training through circuit training such as adding different obstacle stations. This study want to find out which approach helps more to improve the motor skills and social interaction. Both approaches have significant individual benefits but their comparative effects remain unexplored. The aim of this study to fulfil this gap.The methodology for this project will be randomized control trail RCT. The data will be collected from the Child rehabilitation center. The study will be completed in 10 months after the approval of synopsis. 22 autistic children age 5-12 years will be randomly assigned into SPARK program (n-=11) or Game-based training (n=11). All the referred participants will be assessed for the eligibility criteria. Guardians of these participants wo are eligible will be asked to sign the consent form before entering them to the study. Each training will be conducted for 12 weeks with sessions conducted 3 times per week for 30 minutes. Motor Proficiency will be measured by Bruininks-Oseretsky (BOT-2). Social Interaction will be measured by Autism Social Skills Profile (ASSP).. This synopsis will be represented to research ethical committee of Riphah International university, Lahore for ethical approval to conduct this study. Data will be collected through SPSS version 23
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: IMRAN AMJAD, PhD
- Numéro de téléphone: 9233224390125
- E-mail: IMRAN.AMJAD@RIPHAH.EDU.PK
Sauvegarde des contacts de l'étude
- Nom: Muhammad Asif Javed, PhD*
- Numéro de téléphone: 923224209422
- E-mail: a.javed@riphah.edu.pk
Lieux d'étude
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Recrutement
- IHC Hospital
-
Contact:
- Muhammad Asif Javed, PhD*
- Numéro de téléphone: 923224209422
- E-mail: a.javed@riphah.edu.pk
-
Contact:
- IMRAN AHJAD, PHD
- Numéro de téléphone: 9233224390125
- E-mail: imran.amjad@riphah.edu.pk
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
- ASD is diagnosed by Psychologist.
- Age 5-12 years with ASD .
- Participants having IQ greater than 70 by using Wechsler intelligence scale for children (WISC-4)
Exclusion Criteria:
- Visual or auditory impairment or any orthopedic condition.
- Participants currently enrolled in intensive Physiotherapy (to avoid confounding effects).
- Recent traumatic injury and surgery (≤6 months).
- There was previous involvement with the SPARK program among the participants.
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 |
|---|---|
|
Expérimental: Group A: Structured Sports, Play, and Active Recreation for Kids Exercise program (SPARK)
The SPARK intervention includes 36 sessions (3x/week, 40 min/session).
Each session has: 10-min warm-up (scramble activity: prone lying → quadruped → quick stand with bent knees → jumping), 20-min main treatment (heavy fitness: aerobic dance, running, jump ropes for endurance & strength; skill fitness: basketball, football, kickball), and 10-min cool-down (deep breathing)
|
The SPARK intervention consists of 36 sessions, delivered 3 times per week for 40 minutes per session.
Each session is divided into three parts: a 10-minute warm-up, a 20-minute main treatment, and a 10-minute cool-down.
During the warm-up, a scramble interactive activity is performed in four positions: (1) prone lying on a soft surface, (2) quadruped (knees and hands on the floor), (3) quick standing with bent knees, and (4) jumping.
The main treatment follows standard SPARK protocols, including heavy fitness activities (e.g., aerobic dance, running games, jump ropes) to develop endurance, abdomen, and upper body strength, followed by skill fitness activities (e.g., basketball, football, kickball) to improve fitness.
The session ends with a 10-minute cool-down including deep breathing exercises.
Autres noms:
|
|
Expérimental: Group B: Game-Based Training.
Game-based training: 32 sessions (2x/week, 33 min/session).
Each session has three 11-minute segments: warm-up (walking on toes/heels, jogging, running between cones), agility (running over 4 hurdles plus cones, rings, ladder), and agility with skill (catching football, zig-zag through rings, throwing at target, stacking cups).
Three circuits per session in small groups
|
The game-based training intervention consists of 32 sessions over 16 weeks, with 2 sessions per week, each lasting 33 minutes.
Each session is divided into three 11-minute segments: warm-up, agility exercises, and agility with a skill.
The warm-up includes moderate-to-vigorous activities such as walking on toes and heels, jogging, and running fast between two cones placed 10 yards apart.
The agility segment involves running over sequentially added hurdles (up to four), cones, rings, and a ladder.
The final segment combines agility with fine and gross motor skills, including picking up bean bags, throwing a football, stacking cups, walking over hurdles, catching a football, zig-zag running through rings, and throwing a ball at a target.
Participants complete three circuits per session while working in small groups to encourage social interaction
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Bruininks-Oseretsky Test of Motor Proficiency (BOT-2)
Délai: 1 months
|
Children with Autism Spectrum Disorder (ASD) often faces difficulties to perform motor skills.
The Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) is the most widely used assessment tool design to evaluate fine and gross motor skills in children and adolescent age 4 to 21.
|
1 months
|
|
Autism social skills profile ASSP
Délai: 1 months
|
Autism is also characterized by significant impairment in social interactions.Social skills play a vital role in overall child wellbeing and successful integration in society.
These skills include effective communication, cooperation and emotional understanding which helps to develop the meaning full relationships.The autism Social Skills Profile (ASSP) was developed to measure the specific social skills and can be used for planning the intervention that focus on social skills enhancement deficit in children and adolescent of age 6-17 years old
|
1 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Maham Bashir, MS PT, Riphah International University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- REC/RCR&AHS/MAHAMBASHIR
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
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .