- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07634965
Achilles Tendon and Ankle Characterization in Adults With Autism
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Gali Dar, PhD
- Phone Number: +972505662054
- Email: gdar@univ.haifa.ac.il
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Autism
Adult with Autism
|
|
healthy control
healthy adult
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Achilles tendon
Time Frame: baseline
|
Achilles tendon structure via an ultrasound tissue characterization device
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
sensory responsiveness
Time Frame: baseline
|
Sensory Responsiveness Questionnaire.
scale from 58-290 when higher score represent increased responsiveness
|
baseline
|
|
ankle joint range of motion
Time Frame: baseline
|
range of motion measured by goniometer in degrees
|
baseline
|
|
ankle joint muscle strength
Time Frame: baseline
|
ankle joint muscle strength measured by hand held dynamometer (in KgF)
|
baseline
|
|
toe walking
Time Frame: baseline
|
The presence of toe walking via observation on gait (presence / absence)
|
baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 235/26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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