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

NCT06399237 | Completed

• 1 other identifier: MP-20-2018-4003
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posterior Tibial Tendon Dysfunction

Keywords

Posterior tibialis tendon dysfunction, Foot orthoses,

Outcome Measures

Primary Outcomes (2)

• 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

• Comfort of the orthoses

  A comparison of the mean perceived comfort in each experimental condition.

  During the lab session

Study Arms (4)

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).

Device: Foot Orthoses

Custom-fitted orthoses (CFO)

ACTIVE COMPARATOR

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

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)

Device: Foot Orthoses

Interventions

Foot Orthoses DEVICE

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

Also known as: Foot Orthosis

Custom-fitted orthoses (CFO); Custom-fitted orthoses with a 5deg varus (CFVO); Prefabricated foot orthoses (PFO)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

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

Québec, G1V 0A6, Canada

Location

Related 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.

  PMID: 26472584 BACKGROUND

• 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.

  PMID: 24097135 BACKGROUND

• 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.

  PMID: 19022863 BACKGROUND

• 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.

  PMID: 21756121 BACKGROUND

• 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.

  PMID: 33190045 RESULT

MeSH Terms

Conditions

Posterior Tibial Tendon Dysfunction

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Foot Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: May 3, 2024
• Study Start: June 1, 2018
• Primary Completion: August 28, 2018
• Study Completion: September 12, 2019
• Last Updated: May 3, 2024

Record last verified: 2024-04

Locations

CA (1)