- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07634965
Achilles Tendon and Ankle Characterization in Adults With Autism
Studieoversikt
Status
Forhold
Detaljert beskrivelse
This study aims to examine ankle musculoskeletal characteristics in adults with Autism Spectrum Disorder.
A cross-sectional, community-based comparative study will enroll 80 adults aged 18-40, including 40 adults with ASD recruited in partnership with a supported residential community and 40 age- and sex-matched controls. Participants will complete a single assessment session evaluating ankle musculoskeletal characteristics, including tendon structure using ultrasonographic tissue characterization (UTC), ankle strength and range of motion, proprioceptive discrimination using the AMEDA apparatus, and assessment of current and past toe walking, alongside quantitative evaluation of sensory responsiveness using a validated questionnaire (Sensory Responsiveness Questionnaire - SQR). Group comparisons will evaluate differences in ankle structure and function, and association analyses will evaluate relationships among sensory responsiveness, toe-walking status, and ankle measures within the ASD group. Findings will inform the identification of preliminary clinical indicators to support the development of future community-based screening and physiotherapy interventions.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Gali Dar, PhD
- Telefonnummer: +972505662054
- E-post: gdar@univ.haifa.ac.il
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- a diagnosis of ASD, or with another diagnosis that includes features of ASD (such as fragile x),
- independent in daily activities,
- live alone,
- have a moderate-high level of functioning.
- Ability to understand basic instructions for performing the tests, signing an informed consent form or having a guardian sign an informed consent form
Exclusion criteria:
- other neurological diseases (e.g., CP, multiple sclerosis),
- significant orthopedic injuries to the lower limb in the past year,
- previous ankle or Achilles tendon surgeries,
- additional diseases that may affect the structure of the Achilles tendon and ankle,
- who have not signed an informed consent form or are not interested in participating in the study
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
Autism
Adult with Autism
|
|
healthy control
healthy adult
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Achilles tendon
Tidsramme: baseline
|
Achilles tendon structure via an ultrasound tissue characterization device
|
baseline
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
sensory responsiveness
Tidsramme: baseline
|
Sensory Responsiveness Questionnaire.
scale from 58-290 when higher score represent increased responsiveness
|
baseline
|
|
ankle joint range of motion
Tidsramme: baseline
|
range of motion measured by goniometer in degrees
|
baseline
|
|
ankle joint muscle strength
Tidsramme: baseline
|
ankle joint muscle strength measured by hand held dynamometer (in KgF)
|
baseline
|
|
toe walking
Tidsramme: baseline
|
The presence of toe walking via observation on gait (presence / absence)
|
baseline
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
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
- 235/26
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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