Posterior Tibial Tendon DysfunctionNCT06399237
Biomechanical Effects of Three Types of Foot Orthoses in Individuals With Posterior Tibialis Tendon Dysfunction
A study testing Foot Orthoses in people with Posterior Tibial Tendon Dysfunction, run by Laval University at 1 site in Canada.
Trial summary
Background : Posterior tibialis tendon dysfunction (PTTD) is characterized by a loss of function of the muscle caused by the degeneration of the tendon leading to a flattening of the arch. FOs can be used as a treatment option, but their biomechanical effects are not yet fully understood. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posterior Tibial Tendon Dysfunction
- What is being tested?
- Foot Orthoses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2018to 12 Sep 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms located to the medial ankle or foot Pain on palpation to the posterior tibialis muscle tendon Positive single or double heel-rise test Foot flattening and ''too many toes" sign
Who cannot join
- Rigidity of those deformities Pain on palpation of the peroneal muscles Wearing any type of foot and/or ankle orthoses one month prior to the study onset History of corticosteroid injection in the tendon one month prior to the study onset Having a neurological disease or past history of surgery to the affected ankle
Trial locations and contacts
1 site in 1 country.
Canada1 site
Pavillon de l'Éducation Physique et des Sports - Université Laval
Québec, G1V 0A6
About this study
Background :
Posterior tibialis tendon dysfunction (PTTD) is characterized by a loss of function of the muscle caused by the degeneration of the tendon leading to a flattening of the arch. FOs can be used as a treatment option, but their biomechanical effects are not yet fully understood. The aim of this study was to investigate the effects of three different types of foot orthoses (FOs) on gait biomechanics in individuals suffering from PTTD.
Read more
Methods :
Fourteen individuals were recruited with painful stage 1 or 2 PTTD based on the Johnson and Strom's classification. Quantitative gait analysis of the affected limb was performed in four conditions: shoed condition (Shoe), prefabricated FOs condition (PFO), neutral custom FOs condition (CFO) and five degrees varus (medial wedge) with a 4 mm medial heel skive custom FOs condition (CVFO). A curve analysis, using 1D statistical parametric mapping (SMP), was used to assess differences in lower limb joint motion, joint moments and muscle activity over the stance phase of gait across conditions.
- Conditions
- Posterior Tibial Tendon Dysfunction
- Being tested
- Foot Orthoses
- Keywords
- Posterior tibialis tendon dysfunction, Foot orthoses,
- Medical subject headings
- Posterior Tibial Tendon Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot OrthosesDevice
Also called Foot Orthosis
Three types of foot orthoses (FO), Prefabricated FO, Custom FO, Custom with a 5° varus FO
| Study group | Role | What they receive |
|---|---|---|
| No orthoses | No intervention | Walk at a self-selected pace without orthoses. |
| Prefabricated foot orthoses (PFO) | Active comparator | Walk at a self-selected pace with prefabricated foot orthoses (PFO). Receives: Device: Foot Orthoses |
| Custom-fitted orthoses (CFO) | Active comparator | Walk at a self-selected pace with custom-fitted orthoses (CFO) Receives: Device: Foot Orthoses |
| Custom-fitted orthoses with a 5deg varus (CFVO) | Active comparator | Walk at a self-selected pace with custom-fitted orthoses with a 5deg varus (CFVO) Receives: Device: Foot Orthoses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower limbs' joint motion, joint moments and muscle activity
A comparison of the lower limbs' joint motion, joint moments and muscle activity over the stance phase of gait between conditions
Measured: During the lab session
Comfort of the orthoses
A comparison of the mean perceived comfort in each experimental condition.
Measured: During the lab session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 Jun 2018
- Primary completion28 Aug 2018
- Study completion12 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Posterior Tibial Tendon DysfunctionStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Corbeil, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399237
- Sponsor's protocol ID
- MP-20-2018-4003
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2021
- Last updated
- 3 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abousayed MM, Tartaglione JP, Rosenbaum AJ, Dipreta JA. Classifications in Brief: Johnson and Strom Classification of Adult-acquired Flatfoot Deformity. Clin Orthop Relat Res. 2016 Feb;474(2):588-93. doi: 10.1007/s11999-015-4581-6. No abstract available.
PubMed 26472584Barn R, Brandon M, Rafferty D, Sturrock RD, Steultjens M, Turner DE, Woodburn J. Kinematic, kinetic and electromyographic response to customized foot orthoses in patients with tibialis posterior tenosynovitis, pes plano valgus and rheumatoid arthritis. Rheumatology (Oxford). 2014 Jan;53(1):123-30. doi: 10.1093/rheumatology/ket337. Epub 2013 Oct 3.
PubMed 24097135Kulig K, Reischl SF, Pomrantz AB, Burnfield JM, Mais-Requejo S, Thordarson DB, Smith RW. Nonsurgical management of posterior tibial tendon dysfunction with orthoses and resistive exercise: a randomized controlled trial. Phys Ther. 2009 Jan;89(1):26-37. doi: 10.2522/ptj.20070242. Epub 2008 Nov 20.
PubMed 19022863Pataky TC. One-dimensional statistical parametric mapping in Python. Comput Methods Biomech Biomed Engin. 2012;15(3):295-301. doi: 10.1080/10255842.2010.527837. Epub 2011 Jul 14.
PubMed 21756121Chicoine D, Bouchard M, Laurendeau S, Moisan G, Belzile EL, Corbeil P. Biomechanical effects of three types of foot orthoses in individuals with posterior tibial tendon dysfunction. Gait Posture. 2021 Jan;83:237-244. doi: 10.1016/j.gaitpost.2020.11.001. Epub 2020 Nov 6.
PubMed 33190045
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Effects of Three Types of Foot Orthoses in Individuals With Posterior Tibialis Tendon Dysfunction
- ClinicalTrials.gov ID
- NCT06399237
- Acronym / sponsor ID
- MP-20-2018-4003
- Conditions
- Posterior Tibial Tendon Dysfunction
- Keywords
- Posterior tibialis tendon dysfunction, Foot orthoses,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 12 Sep 2019 (actual)
- First posted
- 3 May 2024 (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.
Background :
Posterior tibialis tendon dysfunction (PTTD) is characterized by a loss of function of the muscle caused by the degeneration of the tendon leading to a flattening of the arch. FOs can be used as a treatment option, but their biomechanical effects are not yet fully understood. The aim of this study was to investigate the effects of three different types of foot orthoses (FOs) on gait biomechanics in individuals suffering from PTTD.
Methods :
Fourteen individuals were recruited with painful stage 1 or 2 PTTD based on the Johnson and Strom's classification. Quantitative gait analysis of the affected limb was performed in four conditions: shoed condition (Shoe), prefabricated FOs condition (PFO), neutral custom FOs condition (CFO) and five degrees varus (medial wedge) with a 4 mm medial heel skive custom FOs condition (CVFO). A curve analysis, using 1D statistical parametric mapping (SMP), was used to assess differences in lower limb joint motion, joint moments and muscle activity over the stance phase of gait across conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No orthoses | No intervention | –Walk at a self-selected pace without orthoses. |
| Prefabricated foot orthoses (PFO) | Active comparator | Device: Foot OrthosesWalk at a self-selected pace with prefabricated foot orthoses (PFO). |
| Custom-fitted orthoses (CFO) | Active comparator | Device: Foot OrthosesWalk at a self-selected pace with custom-fitted orthoses (CFO) |
| Custom-fitted orthoses with a 5deg varus (CFVO) | Active comparator | Device: Foot OrthosesWalk at a self-selected pace with custom-fitted orthoses with a 5deg varus (CFVO) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptoms located to the medial ankle or foot Pain on palpation to the posterior tibialis muscle tendon Positive single or double heel-rise test Foot flattening and ''too many toes" sign
Key exclusion criteria (1 listed)
- Rigidity of those deformities Pain on palpation of the peroneal muscles Wearing any type of foot and/or ankle orthoses one month prior to the study onset History of corticosteroid injection in the tendon one month prior to the study onset Having a neurological disease or past history of surgery to the affected ankle
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 |
|---|---|---|
| Foot OrthosesAlso: Foot OrthosisThree types of foot orthoses (FO), Prefabricated FO, Custom FO, Custom with a 5° varus FO | Device | Custom-fitted orthoses (CFO), Custom-fitted orthoses with a 5deg varus (CFVO), Prefabricated foot orthoses (PFO) |
Primary outcome
Lower limbs' joint motion, joint moments and muscle activity
Time frame: During the lab session
A comparison of the lower limbs' joint motion, joint moments and muscle activity over the stance phase of gait between conditions
Comfort of the orthoses
Time frame: During the lab session
A comparison of the mean perceived comfort in each experimental condition.
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 3 May 2024.
- Background: PubMed 26472584Abousayed MM, Tartaglione JP, Rosenbaum AJ, Dipreta JA. Classifications in Brief: Johnson and Strom Classification of Adult-acquired Flatfoot Deformity. Clin Orthop Relat Res. 2016 Feb;474(2):588-93. doi: 10.1007/s11999-015-4581-6. No abstract available.
- Background: PubMed 24097135Barn R, Brandon M, Rafferty D, Sturrock RD, Steultjens M, Turner DE, Woodburn J. Kinematic, kinetic and electromyographic response to customized foot orthoses in patients with tibialis posterior tenosynovitis, pes plano valgus and rheumatoid arthritis. Rheumatology (Oxford). 2014 Jan;53(1):123-30. doi: 10.1093/rheumatology/ket337. Epub 2013 Oct 3.
- Background: PubMed 19022863Kulig K, Reischl SF, Pomrantz AB, Burnfield JM, Mais-Requejo S, Thordarson DB, Smith RW. Nonsurgical management of posterior tibial tendon dysfunction with orthoses and resistive exercise: a randomized controlled trial. Phys Ther. 2009 Jan;89(1):26-37. doi: 10.2522/ptj.20070242. Epub 2008 Nov 20.
- Background: PubMed 21756121Pataky TC. One-dimensional statistical parametric mapping in Python. Comput Methods Biomech Biomed Engin. 2012;15(3):295-301. doi: 10.1080/10255842.2010.527837. Epub 2011 Jul 14.
- Results publication: PubMed 33190045Chicoine D, Bouchard M, Laurendeau S, Moisan G, Belzile EL, Corbeil P. Biomechanical effects of three types of foot orthoses in individuals with posterior tibial tendon dysfunction. Gait Posture. 2021 Jan;83:237-244. doi: 10.1016/j.gaitpost.2020.11.001. Epub 2020 Nov 6.
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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 Foot Orthoses in people with Posterior Tibial Tendon Dysfunction, run by Laval University at 1 site in Canada.
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 1 inclusion and 1 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 3 May 2024. 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 Canada. 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?
Lower limbs' joint motion, joint moments and muscle activity (time frame: During the lab session). 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 NCT06399237, which also lists 5 linked publications.
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 3 May 2024.