Back to resultsOrthotics and Achilles Load in Runners
Primary Purpose
Achilles Tendinopathy, Flatfoot, Sports Injury
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
CASO
HL
Sponsored by
About this trial
This is an interventional treatment trial for Achilles Tendinopathy
Eligibility Criteria
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
Sites / Locations
- CUHK
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Runner
Arm Description
Subject will undergo an assessment wearingeither the CASO or the HL. Sequence of CASO of HL will be randomly allocated.
Outcomes
Primary Outcome Measures
Peak plantarflexion moment
8-camera motion capturing system
Peak Achilles tendon load
Piezoelectric force platform, computed using the Newton-Euler inverse-dynamics
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04003870
Brief Title
Orthotics and Achilles Load in Runners
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North District Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Compare Customized arch support orthoses (CASO) and orthotic heel lift (HL) on the effect of ATL in recreational runners with pronated feet.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendinopathy, Flatfoot, Sports Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Runner
Arm Type
Experimental
Arm Description
Subject will undergo an assessment wearingeither the CASO or the HL. Sequence of CASO of HL will be randomly allocated.
Intervention Type
Device
Intervention Name(s)
CASO
Intervention Description
Customized arch support orthoses (CASO)
Intervention Type
Device
Intervention Name(s)
HL
Intervention Description
Orthotic Heel Lift (HL)
Primary Outcome Measure Information:
Title
Peak plantarflexion moment
Description
8-camera motion capturing system
Time Frame
Day 0
Title
Peak Achilles tendon load
Description
Piezoelectric force platform, computed using the Newton-Euler inverse-dynamics
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
CUHK
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31722697
Citation
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/s12891-019-2898-0.
Results Reference
result
Links:
URL
https://rdcu.be/b38yd
Description
Related Info
Learn more about this trial
Orthotics and Achilles Load in Runners
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