Biomechanical Effects of Three Types of Foot Orthoses in Individuals With Posterior Tibialis Tendon Dysfunction

NCT ID: NCT06399237

Last Updated: 2024-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-09-12

Brief Summary

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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.

Detailed Description

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Conditions

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Posterior Tibial Tendon Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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No orthoses

Walk at a self-selected pace without orthoses.

Group Type NO_INTERVENTION

No interventions assigned to this group

Prefabricated foot orthoses (PFO)

Walk at a self-selected pace with prefabricated foot orthoses (PFO).

Group Type ACTIVE_COMPARATOR

Foot Orthoses

Intervention Type DEVICE

Three types of foot orthoses (FO), Prefabricated FO, Custom FO, Custom with a 5° varus FO

Custom-fitted orthoses (CFO)

Walk at a self-selected pace with custom-fitted orthoses (CFO)

Group Type ACTIVE_COMPARATOR

Foot Orthoses

Intervention Type DEVICE

Three types of foot orthoses (FO), Prefabricated FO, Custom FO, Custom with a 5° varus FO

Custom-fitted orthoses with a 5deg varus (CFVO)

Walk at a self-selected pace with custom-fitted orthoses with a 5deg varus (CFVO)

Group Type ACTIVE_COMPARATOR

Foot Orthoses

Intervention Type DEVICE

Three types of foot orthoses (FO), Prefabricated FO, Custom FO, Custom with a 5° varus FO

Interventions

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Foot Orthoses

Three types of foot orthoses (FO), Prefabricated FO, Custom FO, Custom with a 5° varus FO

Intervention Type DEVICE

Other Intervention Names

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Foot Orthosis

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laval University

OTHER

Sponsor Role lead

Responsible Party

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Philippe Corbeil

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pavillon de l'Éducation Physique et des Sports - Université Laval

Québec, , Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 26472584 (View on PubMed)

Barn 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.

Reference Type BACKGROUND
PMID: 24097135 (View on PubMed)

Kulig 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.

Reference Type BACKGROUND
PMID: 19022863 (View on PubMed)

Pataky 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.

Reference Type BACKGROUND
PMID: 21756121 (View on PubMed)

Chicoine 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.

Reference Type RESULT
PMID: 33190045 (View on PubMed)

Other Identifiers

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MP-20-2018-4003

Identifier Type: -

Identifier Source: org_study_id

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