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NCT04003870 Clinical Trial

Orthotics and Achilles Load in Runners

Achilles Tendinopathy Clinical Trial

Official title:
Controlled Trial to Compare the Achilles Tendon Load During Running in Flatfeet Subjects Using a Customized Arch Support Orthoses vs an Orthotic Heel Lift

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04003870
Other study ID # CUHK
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date April 1, 2019

Study information
Verified date May 2020
Source North District Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Compare Customized arch support orthoses (CASO) and orthotic heel lift (HL) on the effect of ATL in recreational runners with pronated feet.

Description:

This was a controlled laboratorial, within subject, repeated measures study. The aim of this study was to compare two clinically applied treatment options: Customized arch support orthoses (CASO) and orthotic heel lift (HL) on the effect of ATL in recreational runners with pronated feet. It implicated to provide a better understanding of the types of foot orthoses for flatfeet runners and additional biomechanical evidence for the clinical field to guide orthotic prescription as well as selection for Achilles tendinopathy management.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date April 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion:

- Foot Posture Index (FPI) was used as evaluating pronated foot posture. Subjects with FPI scores of 6-12 were recruited in the current study.

- All participants should be free of Achilles tendinopathy and triceps surae injury for 6 months.

- no previous surgery.

- not previously attempted any foot orthoses intervention before this study.

Exclusion:

- leg-length discrepancy

- rigid forefoot varus deformity

- gastrocnemius equinus

- structural hallux limitus, or rigidus

- Any musculoskeletal or neurological disorders

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CASO
Customized arch support orthoses (CASO)
• HL
Orthotic Heel Lift (HL)

Locations
Country Name City State
Hong Kong CUHK Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
North District Hospital

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

Lee KKW, Ling SKK, Yung PSH. Controlled trial to compare the Achilles tendon load during running in flatfeet participants using a customized arch support orthoses vs an orthotic heel lift. BMC Musculoskelet Disord. 2019 Nov 13;20(1):535. doi: 10.1186/s128 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Peak plantarflexion moment 8-camera motion capturing system Day 0
Primary Peak Achilles tendon load Piezoelectric force platform, computed using the Newton-Euler inverse-dynamics Day 0
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