- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: IMRAN AMJAD, PhD
- Telefoonnummer: 9233224390125
- E-mail: IMRAN.AMJAD@RIPHAH.EDU.PK
Studie Contact Back-up
- Naam: Muhammad Asif Javed, PhD*
- Telefoonnummer: 923224209422
- E-mail: a.javed@riphah.edu.pk
Studie Locaties
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Werving
- IHC Hospital
-
Contact:
- Muhammad Asif Javed, PhD*
- Telefoonnummer: 923224209422
- E-mail: a.javed@riphah.edu.pk
-
Contact:
- IMRAN AHJAD, PHD
- Telefoonnummer: 9233224390125
- E-mail: imran.amjad@riphah.edu.pk
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
Andere namen:
|
|
Experimenteel: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Bruininks-Oseretsky Test of Motor Proficiency (BOT-2)
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Maham Bashir, MS PT, Riphah International University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- REC/RCR&AHS/MAHAMBASHIR
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .