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CompletedNCT04003870Updated May 15, 2020

Orthotics and Achilles Load in Runners

An interventional study of CASO and HL in Achilles Tendinopathy, Flatfoot and Sports Injury, sponsored by North District Hospital. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-15.

Sponsored by North District Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jan 2019, registered Jun 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Achilles Tendinopathy
  • Flatfoot
  • Sports Injury
03

In context

Flatfoot

173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.

This study's enrollment of 12 is below the median of 40 across 122 interventional studies indexed under Flatfoot.

Browse Flatfoot studies →

Lead sponsor

North District Hospital is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 criteria

Exclusion:

  • leg-length discrepancy
  • rigid forefoot varus deformity
  • gastrocnemius equinus
  • structural hallux limitus, or rigidus
  • Any musculoskeletal or neurological disorders
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Runner

    Subject will undergo an assessment wearingeither the CASO or the HL. Sequence of CASO of HL will be randomly allocated.

    Device: CASO · Device: HL

Interventions

  • DeviceCASO

    Customized arch support orthoses (CASO)

  • DeviceHL

    Orthotic Heel Lift (HL)

06

What researchers measure

Primary outcomes

  1. Peak plantarflexion moment

    8-camera motion capturing system

    Time frame: Day 0

  2. Peak Achilles tendon load

    Piezoelectric force platform, computed using the Newton-Euler inverse-dynamics

    Time frame: Day 0

07

Study locations

1 site
  • CUHK
    Hong Kong, Hong Kong
08

References and documents

Publications

  • 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. PubMed 31722697 ↗

Related links

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2019 to primary completion in Apr 2019, 3 months.

Of 89 non-industry interventional studies with no phase under Flatfoot, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 15. This study's 3 months is below that.

Counting every sponsor, half of 89 studies reached it within 7 months; a quarter within 2 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 25, 2019
First posted
Jul 1, 2019
StartActual
Jan 1, 2019
Primary completionActual
Apr 1, 2019
CompletionActual
Apr 1, 2019
Last update
May 15, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 15, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04003870
Lead sponsor
North District Hospital
Responsible party
Samuel KK Ling (Clinical Assistant Professor of Orthopaedics and Traumatology, Chinese University of Hong Kong) — Principal investigator
First posted
Jul 1, 2019
Start date
Jan 1, 2019
Primary completion
Apr 1, 2019
Completion
Apr 1, 2019
Last update
May 15, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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