NCT06172517

Brief Summary

Foot pain is common in the general population. Plantar fasciopathy may affect 7% of the population at some time in their lives, but the incidence increases with age. This plantar problem is characterized by severe pain under the foot (at plantar level), which can be very incapacitating and disabling. This can lead to absenteeism from work, particularly for employees working in a standing posture. Various therapeutic avenues can be used to reduce pain and improve functionality, such as physiotherapy, infiltrations and surgery. In this research project, the propose the use of a conservative approach through the use of foot orthoses, which appears to be effective in reducing pain. The aim of the study is thus to better understand the effect of foot orthoses on postural balance and walking in workers with plantar fasciopathy. Participants will be assessed at baseline and eight weeks later to observe measured changes and clinical improvements following orthotic wear. Balance and gait pattern will be assessed using technological tools that have been validated in this respect. Participants will also be asked about their pain intensity. The hypothesis is that wearing the orthosis will improve the participants' balance and walking abilities, as well as reduce the level or intensity of their pain. In addition, this study could have an impact on the rate of absenteeism from work from current context of labour shortages.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

January 8, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2024

Completed
Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

12 months

First QC Date

November 29, 2023

Last Update Submit

April 17, 2025

Conditions

Keywords

Postural controlplantar orthosesplantar fasciopathyBiomechanicsGaitPain

Outcome Measures

Primary Outcomes (2)

  • Postural control measures

    The participants will perform two 30-second trials on a strength platform (model BIOMEC400), the following tasks: without muscular vibration, with bilateral Achilles tendon vibration (Techno® concept VibrasensTM, France) in bipodal posture, and a balance task in semi-tandem posture with eyes open and closed. The vibration frequency chosen for the regions (sural triceps) will be 80 Hz. Center of Pressure (CoP) metrics will be used as main outcome such as sway CoP velocity variable (cm/s).

    baseline,immediate only for experimental group), and after 8 weeks.

  • Gait measures

    The participants will be asked to walk at normal, slow and fast speeds on a GaitRite treadmill (GAI-TRite® Platinum Plus System 16' - 4.876 m, SN: Q209, CIR Systems Inc., Franklin, NJ, USA). Participants will perform each task twice.Main gait parameters will be used as main outcomes such as velocity in m/s.

    baseline,immediate only for experimental group), and after 8 weeks.

Secondary Outcomes (4)

  • Ankle mobility and foot position measure

    baseline and after 8 weeks.

  • Lower Extremity Functional measure

    baseline and after 8 weeks.

  • Pain measure by Foot function index

    baseline and after 8 weeks.

  • Pain duration

    baseline and after 8 weeks.

Study Arms (2)

Othesis intervention

EXPERIMENTAL

This group with custom-made foot orthotics prescribed by podiatrists (foot impression, polypropylene orthotics and covering at podiatrists' discretion).

Other: Orthosis intervention

Control group

NO INTERVENTION

Without orthesis prescriptions by podiatrists.

Interventions

Clinical feasibility trial with one group using a custom-made foot orthotics prescribed by podiatrists (foot impression, polypropylene orthotics and covering at podiatrists' discretion).

Othesis intervention

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Present a history of pain under the heels for more than 3 months
  • Have a diagnosis of plantar fasciopathy
  • Pain of at least 3/10 under the heel
  • Have post-static dyskinesia
  • To be in the job market (adults between 20 and 65 years)

You may not qualify if:

  • Severe systemic diseases
  • Red flags (e.g. tumors),
  • Musculoskeletal deformities affecting the lower limbs
  • Musculoskeletal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rubens da Silva

Saguenay, Quebec, G7H 2B1, Canada

Location

Related Publications (13)

  • Duncan JR, Potter CB, Cappellini MD, Kurtz JB, Anderson MJ, Weatherall DJ. Aplastic crisis due to parvovirus infection in pyruvate kinase deficiency. Lancet. 1983 Jul 2;2(8340):14-6. doi: 10.1016/s0140-6736(83)90005-3.

    PMID: 6134886BACKGROUND
  • Beeson P. Plantar fasciopathy: revisiting the risk factors. Foot Ankle Surg. 2014 Sep;20(3):160-5. doi: 10.1016/j.fas.2014.03.003. Epub 2014 Mar 22.

    PMID: 25103701BACKGROUND
  • Ichioka T, Tashiro T, Hara T, Ichioka E. [Trial testing of the auto-refractometer NIDEK AR-3000 for mass examination of children and kindergarten, primary, junior high, and high school students]. Josai Shika Daigaku Kiyo. 1985;14(1):139-47. No abstract available. Japanese.

    PMID: 3866618BACKGROUND
  • Richer L, Fortin E, Gagnon G, Ngomo S, Fernandes KBP, Cortis C, Sobczak S, da Silva RA. Impact of plantar fasciitis on postural control and walking in young middle-aged adults. Foot (Edinb). 2022 Dec;53:101951. doi: 10.1016/j.foot.2022.101951. Epub 2022 Nov 4.

    PMID: 36463613BACKGROUND
  • Crawford F, Thomson CE. WITHDRAWN. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD000416. doi: 10.1002/14651858.CD000416.pub2.

    PMID: 20091508BACKGROUND
  • Goguel V, Rosbash M. Splice site choice and splicing efficiency are positively influenced by pre-mRNA intramolecular base pairing in yeast. Cell. 1993 Mar 26;72(6):893-901. doi: 10.1016/0092-8674(93)90578-e.

    PMID: 8458083BACKGROUND
  • Anderson J, Stanek J. Effect of foot orthoses as treatment for plantar fasciitis or heel pain. J Sport Rehabil. 2013 May;22(2):130-6. doi: 10.1123/jsr.22.2.130. Epub 2012 Oct 2.

    PMID: 23037146BACKGROUND
  • Redmond AC, Crosbie J, Ouvrier RA. Development and validation of a novel rating system for scoring standing foot posture: the Foot Posture Index. Clin Biomech (Bristol). 2006 Jan;21(1):89-98. doi: 10.1016/j.clinbiomech.2005.08.002. Epub 2005 Sep 21.

    PMID: 16182419BACKGROUND
  • House WF, Hitselberger WE, Horn KL. The middle fossa transpetrous approach to the anterior-superior cerebellopontine angle. Am J Otol. 1986 Jan;7(1):1-4.

    PMID: 3484905BACKGROUND
  • Mok J. HIV infection in children. J R Coll Gen Pract. 1988 Aug;38(313):342-4. No abstract available.

    PMID: 3076903BACKGROUND
  • Pourtier-Piotte C, Pereira B, Soubrier M, Thomas E, Gerbaud L, Coudeyre E. French validation of the Foot Function Index (FFI). Ann Phys Rehabil Med. 2015 Oct;58(5):276-82. doi: 10.1016/j.rehab.2015.07.003. Epub 2015 Sep 4.

    PMID: 26343763BACKGROUND
  • Kadri MA, Chevalier G, Mecheri H, Ngomo S, Lavalliere M, da Silva RA, Beaulieu LD. Time course and variability of tendinous vibration-induced postural reactions in forward and backward directions. J Electromyogr Kinesiol. 2020 Apr;51:102386. doi: 10.1016/j.jelekin.2020.102386. Epub 2020 Jan 20.

    PMID: 32014802BACKGROUND
  • Hayashi K, Hirata Y, Kurushima H, Saeki M, Amioka H, Nomura S, Kuga Y, Ohkura Y, Ohtani H, Kajiyama G. Effect of dietary hydrogenated corn oil (trans-octadecenoate rich oil) on plasma and hepatic cholesterol metabolism in the hamster. Atherosclerosis. 1993 Feb;99(1):97-106. doi: 10.1016/0021-9150(93)90055-y.

    PMID: 8461065BACKGROUND

MeSH Terms

Conditions

Foot DiseasesMobility LimitationPain

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic Manifestations

Study Officials

  • Rubens da Silva, PhD

    Université du Québec à Chicoutimi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Clinical intervention by orthoses
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director and professor

Study Record Dates

First Submitted

November 29, 2023

First Posted

December 15, 2023

Study Start

January 8, 2024

Primary Completion

December 28, 2024

Study Completion

December 28, 2024

Last Updated

April 23, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations