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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06294093
Other study ID # 026/24
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2024
Est. completion date February 15, 2025

Study information

Verified date March 2024
Source University of Haifa
Contact Gali Dar, Prof
Phone +972505662054
Email galidar@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

this study will investigate the structure of the Achilles tendon and functional tests in road runners compared to treadmill runners.


Description:

Healthy runners (road and treadmill runners) who run regularly at least twice a week for half an hour, over 80% of the training on the treadmill or road, will be recruited for the study. All subjects will fill out a demographic questionnaire for personal details (age, sex, height, weight, past injuries, training). Each participant will undergo functional tests in random order: 1. Examination of the morphology of the Achilles tendon - will be examined by ultrasound tissue characterized (UTC) 2. Balance test - Y Balance Test 3. Proprioception test - AMEDA device 4. Muscle strength test - manual dynamometer for testing gastrocnemius muscle strength. 5. Gastrocnemius muscle endurance test - single leg heel raise test until fatigue. A comparison will be made between the two study groups.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date February 15, 2025
Est. primary completion date February 15, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - run regularly at least twice a week for half an hour, - over 80% of the training on a treadmill or road Exclusion Criteria: - pain or injury to Achilles tendon during the 6 months, preventing running for at least 3 days. - past Achilles tendon surgeries, - sprained ankle in the last six months, - lower limb and back pain while running - participants who report running with minimalist shoes.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Haifa Zinman College of Physical Education and Sports Sciences

References & Publications (1)

Dar G, Waddington G, Stern M, Dotan N, Steinberg N. Differences Between Long Distance Road Runners and Trail Runners in Achilles Tendon Structure and Jumping and Balance Performance. PM R. 2020 Aug;12(8):794-804. doi: 10.1002/pmrj.12296. Epub 2020 Jan 18. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary ultrasound tissue characterized percentage of type 1,2,3,4 fibers within the tendon baseline
Primary Balance test Y Balance Test - composite score: sum of 3 reach directions in centimeters divided by 3 times the limb length then multiplied by 100 baseline
Primary Proprioception test AMEDA device - scores between 0 and 1, A higher score represents better proprioception ability. baseline
Primary muscle strength test hand held dynamometer dynamometer assessment of Gastrocnemius muscle baseline
Primary endurance test gastrocnemius muscle number of single leg heel raise test until fatigue baseline
See also
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Completed NCT02532595 - TDN, Manual Therapy and Exercise For the Management of Achilles Tendinopathy N/A
Enrolling by invitation NCT06114368 - Endoscopic Flexor Hallucis Longus Transfer vs Minimally Invasive Repair in Acute Achilles Tendon Rupture
Completed NCT01343836 - Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy Phase 2/Phase 3