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

Posterior Tibial Tendon Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06399237
• Other study ID #: MP-20-2018-4003
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: September 12, 2019

Study information

• Verified date: April 2024
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 12, 2019
• Est. primary completion date: August 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Posterior Tibial Tendon Dysfunction

Intervention

Device:
• Foot Orthoses
Three types of foot orthoses (FO), Prefabricated FO, Custom FO, Custom with a 5° varus FO

Locations

Country	Name	City	State
Canada	Pavillon de l'Éducation Physique et des Sports - Université Laval	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. E — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	During the lab session
Primary	Comfort of the orthoses	A comparison of the mean perceived comfort in each experimental condition.	During the lab session