- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07634965
Achilles Tendon and Ankle Characterization in Adults With Autism
Studieoversigt
Status
Betingelser
Detaljeret 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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Gali Dar, PhD
- Telefonnummer: +972505662054
- E-mail: gdar@univ.haifa.ac.il
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
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 undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Autism
Adult with Autism
|
|
healthy control
healthy adult
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Achilles tendon
Tidsramme: baseline
|
Achilles tendon structure via an ultrasound tissue characterization device
|
baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 235/26
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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