Achilles TendinopathyNCT04003870
Orthotics and Achilles Load in Runners
A study testing CASO and HL in people with Achilles Tendinopathy and Flatfoot, run by North District Hospital at 1 site in Hong Kong.
Trial summary
Compare Customized arch support orthoses (CASO) and orthotic heel lift (HL) on the effect of ATL in recreational runners with pronated feet. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Achilles Tendinopathy, Flatfoot, Sports Injury
- What is being tested?
- CASO and HL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2019to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- leg-length discrepancy
- rigid forefoot varus deformity
- gastrocnemius equinus
- structural hallux limitus, or rigidus
- Any musculoskeletal or neurological disorders
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Achilles Tendinopathy, Flatfoot, Sports Injury
- Being tested
- CASO, HL
- Medical subject headings
- Flatfoot, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CASODevice
Customized arch support orthoses (CASO)
HLDevice
Orthotic Heel Lift (HL)
| Study group | Role | What they receive |
|---|---|---|
| Runner | Experimental | Subject will undergo an assessment wearingeither the CASO or the HL. Sequence of CASO of HL will be randomly allocated. Receives: Device: CASO; Device: HL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plantarflexion moment
8-camera motion capturing system
Measured: Day 0
Peak Achilles tendon load
Piezoelectric force platform, computed using the Newton-Euler inverse-dynamics
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start1 Jan 2019
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- North District Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel KK Ling, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003870
- Sponsor's protocol ID
- CUHK
- Status last verified
- May 2020
- First submitted
- 25 Jun 2019
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04003870
- Acronym / sponsor ID
- CUHK
- Conditions
- Achilles Tendinopathy, Flatfoot, Sports Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- North District HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Runner | Experimental | Device: CASO, Device: HLSubject will undergo an assessment wearingeither the CASO or the HL. Sequence of CASO of HL will be randomly allocated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- leg-length discrepancy
- rigid forefoot varus deformity
- gastrocnemius equinus
- structural hallux limitus, or rigidus
- Any musculoskeletal or neurological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CASOCustomized arch support orthoses (CASO) | Device | Runner |
| HLOrthotic Heel Lift (HL) | Device | Runner |
Primary outcome
Peak plantarflexion moment
Time frame: Day 0
8-camera motion capturing system
Peak Achilles tendon load
Time frame: Day 0
Piezoelectric force platform, computed using the Newton-Euler inverse-dynamics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Results publication: PubMed 31722697Lee 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CASO and HL in people with Achilles Tendinopathy and Flatfoot, run by North District Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak plantarflexion moment (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04003870, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.