- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07576907
Ayre's Sensory-Motor Integration Exercises and Sensory Modulation And Motor Skills In Children With ASD
Effects of Ayre's Sensory-Motor Integration Exercises On Sensory Modulation And Motor Skills In Children With Autism Spectrum Disorder
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Autism Spectrum Disorder (ASD) is increasingly affecting children around the globe, bringing with it a variety of behavioral, social, and developmental hurdles.
One of the more subtle yet significant challenges faced by many children with ASD is trouble with sensory modulation and motor coordination. These kids often find it hard to process sensory information in a way that allows them to engage meaningfully with their surroundings. As a result, they may experience behavioral issues, struggle with motor planning, and have a harder time participating in daily activities. To help with this, sensory-motor integration exercises are designed to enhance how the nervous system interprets and reacts to sensory input, leading to smoother and more coordinated physical responses. While these therapies have been looked into in various parts of the world, their application in structured and culturally relevant ways in South Asia is still quite limited. This project seeks to explore how a sensory-motor integration intervention can impact sensory responsiveness and motor skill development in children with ASD. This study will adopt a quasi-experimental design, featuring assessments before and after the intervention for both the experimental and control groups. We plan to recruit thirty children aged 9 to 11 years, all diagnosed with ASD, from a local clinical setting. Participants will be randomly assigned to either a treatment group, which will undergo 12 sessions of sensory-motor integration exercises, or a control group that will receive standard care. Each session will include structured sensory-based activities based on Ayres Sensory Integration® principles. We will utilize tools TGMD and Sensory Modulation Assessment Tool to evaluate outcomes. The quantitative data collected will be analyzed to compare improvements in sensory and motor skills between the two groups. The goal is to support the incorporation of sensory-motor strategies into rehabilitation programs for children with ASD, especially in low-resource settings.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Imran Amjad, PhD
- Telefonnummer: 03324390125
- E-post: imran.amjad@riphah.edu.pk
Studer Kontakt Backup
- Navn: Muhammad Asif Javed, PhD*
- Telefonnummer: +923224209422
- E-post: a.javed@riphah.edu.pk
Studiesteder
-
-
Punjab Province
-
Faisalābad, Punjab Province, Pakistan
- Rekruttering
- Allied Hospital
-
Hovedetterforsker:
- Maha Sattar, MS-PPT
-
Underetterforsker:
- Eram Aslam, MS
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Diagnosis of Autism Spectrum Disorder (ASD) confirmed by a psychiatrist/psychologist.
- Children aged 9-11 years.
- Moderate severity of ASD.
Exclusion Criteria:
- Use of any sedative/hypnotic drugs.
- Comorbid psychological or neurological disorders (e.g., epilepsy).
- Withdrawal of consent at any point during the study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Ayre's sensoray integration exercises
Conducted over 12 sessions (3 times/week for 4 weeks), each session lasting ~45 minutes. Exercises based on Ayres' sensory integration therapy and included, Activities for tactile, proprioceptive, and vestibular stimulation. Tasks like pressing play dough, crawling, balancing, jumping, swinging, and obstacle navigation. Sessions were individualized and child-centred to promote adaptive responses |
Ayres' Sensory-Motor Integration Exercises are play-based therapeutic activities designed to improve how children process sensory information.
They target tactile, proprioceptive, and vestibular systems through tasks like swinging, balancing, crawling, and object manipulation.
Sessions are individualized and child-centered to promote adaptive responses, motor coordination, and functional skills.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
TGMD-2
Tidsramme: 3rd Day
|
The Test of Gross Motor Development-2 (TGMD-2) is a standardized assessment used to evaluate gross motor skills in children aged 3-10 years.
It measures locomotor and object control skills, with each performance criterion scored as 1 (present) or 0 (absent).
The raw score for each subtest ranges from 0 (lowest) to 48 (highest), while the overall Gross Motor Quotient (GMQ) ranges from 46 to 160, with higher scores indicating better motor performance.
|
3rd Day
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Eram Aslam, MS, Riphah International University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Miller LJ, Anzalone ME, Lane SJ, Cermak SA, Osten ET. Concept evolution in sensory integration: a proposed nosology for diagnosis. Am J Occup Ther. 2007 Mar-Apr;61(2):135-40. doi: 10.5014/ajot.61.2.135. No abstract available.
- Lu M, Pang F, Wang R, Liu Y, Peng T. The association between autistic traits and excessive smartphone use in Chinese college students: The chain mediating roles of social interaction anxiety and loneliness. Res Dev Disabil. 2022 Dec;131:104369. doi: 10.1016/j.ridd.2022.104369. Epub 2022 Oct 26.
- Martel M, Finos L, Bahmad S, Koun E, Salemme R, Sonie S, Fourneret P, Schmitz C, Roy AC. Motor deficits in autism differ from that of developmental coordination disorder. Autism. 2024 Feb;28(2):415-432. doi: 10.1177/13623613231171980. Epub 2023 May 25.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Riphah/G-III/RCR&AHS/B45-185
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .