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RehabilitationNCT06172517

Plantar Fasciitis Management on Postural Control

A study testing Orthosis intervention in people with Rehabilitation and Aging Problems, run by Université du Québec à Chicoutimi at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Rehabilitation, Aging Problems, Foot Diseases
What is being tested?
Orthosis intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteCanada
Study dates
8 Jan 2024to 28 Dec 2024
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 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Rubens da Silva

    Saguenay, Quebec, G7H 2B1

Other trials in Canada

About this study

Official title: Impact of Plantar Orthosis on Postural Control and Gait in Individuals With Plantar Fasciopathy

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.

Read the detailed description

Plantar fasciopathy is a musculoskeletal disorder, known as a degeneration of the plantar fascia associated with a sensation of pain at plantar level. This disorder, for which around 2 million people a year receive treatment, has a prevalence of 3.6% to 7%, affecting both men and women between the ages of 45 and 64, and increasing with age. People aged between 25 and 65, who make up the majority of the working population, present 83% of plantar fasciopathy cases. According to CNESST statistics for 2022, 15,310 files opened concerned musculoskeletal disorders of the lower limb, 2133 of which involved the feet. There is also evidence of a possible cause-effect relationship between the number of hours spent standing or walking and the risk of developing plantar fasciopathy, which is indeed a major risk factor for many active workers. People with plantar fasciopathy will be absent from work more regularly, contributing to lower productivity at work. In addition to reduced work productivity, the cost of treatment has been estimated at US$584 million in the United States alone. In addition to pain, other deficits can be observed in people with plantar fasciopathy. A recent study also demonstrated its impact from a biomechanical point of view, notably on postural balance and gait in young adults suffering from this health problem. A number of treatments are currently used to treat this clinical foot condition, both conservatively and surgically. Among the most widely used conservative treatments, foot orthoses have been shown to be effective in reducing pain, despite the paucity of studies on the issue. Some studies have also demonstrated its effects on balance measures. Or, balance afferents originate from the somatosensory system, and tendon vibration can disrupt this system. However, few studies have measured its effects on postural control reactions via tendon vibration following orthotic use and in an ageing population, and no study has specifically investigated the effect of plantar orthoses in cases of plantar fasciopathy on gait pattern parameters in ageing workers.

Being tested
Orthosis intervention
Keywords
Postural control, plantar orthoses, plantar fasciopathy, Biomechanics, Gait, Pain
Medical subject headings
Foot Diseases, Mobility Limitation, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orthosis interventionOther

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

Study groups in NCT06172517
Study groupRoleWhat they receive
Othesis interventionExperimentalThis group with custom-made foot orthotics prescribed by podiatrists (foot impression, polypropylene orthotics and covering at podiatrists' discretion).
Receives: Other: Orthosis intervention
Control groupNo interventionWithout orthesis prescriptions by podiatrists.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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.

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

Secondary outcomes (4)
  1. Ankle mobility and foot position measure

    Ankle mobility will be measured using the Weight-Bearing Lunge Test will be used to assess foot positioning.

    Measured: baseline and after 8 weeks.

  2. Lower Extremity Functional measure

    The Lower Extremity Functional Scale(LEFS) questionnaire will be used to measure participants' level of functionality in the lower limbs. The Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals. The LEFS can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention. The columns on the scale are summed to get a total score. The maximum score is 80. he lower the score the greater the disability. The minimal detectable change is 9 scale points.

    Measured: baseline and after 8 weeks.

  3. Pain measure by Foot function index

    Foot Function Index will be used to measure foot pain and functionality. This index consists of 23 self-reported items divided into 3 subcategories: pain, disability and activity limitation. The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week.

    The activity limitation subcategory consists of 5 items and measures limitations in activities because of foot problems, such as staying in bed all day. Recorded on a visual analogue scale (VAS), scores range from 0 to 100 mm, with higher scores indicating worse pain. Both total and subcategory scores are calculated.

    Measured: baseline and after 8 weeks.

  4. Pain duration

    In addition to sef-reported pain intensity and duration in number of months will calculated.

    Measured: baseline and after 8 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2023
  2. Study start8 Jan 2024
  3. Primary completion28 Dec 2024
  4. Study completion28 Dec 2024

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
Clinical intervention by orthoses
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06172517
Sponsor's protocol ID
2020-404
Status last verified
Apr 2025
First submitted
29 Nov 2023
Last updated
23 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Monteagudo M, de Albornoz PM, Gutierrez B, Tabuenca J, Alvarez I. Plantar fasciopathy: A current concepts review. EFORT Open Rev. 2018 Aug 29;3(8):485-493. doi: 10.1302/2058-5241.3.170080. eCollection 2018 Aug.

    PubMed 30237906
  • 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.

    PubMed 25103701
  • McClinton SM, Flynn TW, Heiderscheit BC, McPoil TG, Pinto D, Duffy PA, Bennett JD. Comparison of usual podiatric care and early physical therapy intervention for plantar heel pain: study protocol for a parallel-group randomized clinical trial. Trials. 2013 Dec 3;14:414. doi: 10.1186/1745-6215-14-414.

    PubMed 24299257
  • 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.

    PubMed 36463613
  • 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.

    PubMed 20091508
  • Morrissey D, Cotchett M, Said J'Bari A, Prior T, Griffiths IB, Rathleff MS, Gulle H, Vicenzino B, Barton CJ. Management of plantar heel pain: a best practice guide informed by a systematic review, expert clinical reasoning and patient values. Br J Sports Med. 2021 Oct;55(19):1106-1118. doi: 10.1136/bjsports-2019-101970. Epub 2021 Mar 30.

    PubMed 33785535
  • 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.

    PubMed 23037146
  • 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.

    PubMed 16182419
  • Chisholm MD, Birmingham TB, Brown J, Macdermid J, Chesworth BM. Reliability and validity of a weight-bearing measure of ankle dorsiflexion range of motion. Physiother Can. 2012 Fall;64(4):347-55. doi: 10.3138/ptc.2011-41.

    PubMed 23997389
  • Rene F, Casimiro L, Tremblay M, Brosseau L, Lefebvre A, Beaudouin M, Belliveau V, Bergeron LP. Une version canadienne francaise du Lower Extremity Functional Scale (LEFS) : L'Echelle fonctionnelle des membres inferieurs (EFMI), partie I. Physiother Can. 2011 Spring;63(2):242-8. doi: 10.3138/ptc.2010-11F. Epub 2011 Apr 13. French.

    PubMed 22379265
  • 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.

    PubMed 26343763
  • 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.

    PubMed 32014802
  • Lauzier L, Kadri MA, Bouchard E, Bouchard K, Gaboury S, Gagnon JM, Girard MP, Larouche A, Robert R, Lapointe P, da Silva RA, Beaulieu LD. Vibration of the Whole Foot Soles Surface Using an Inexpensive Portable Device to Investigate Age-Related Alterations of Postural Control. Front Hum Neurosci. 2021 Sep 10;15:719502. doi: 10.3389/fnhum.2021.719502. eCollection 2021.

    PubMed 34566603

Questions about this trial

What is this clinical trial studying?

A study testing Orthosis intervention in people with Rehabilitation and Aging Problems, run by Université du Québec à Chicoutimi 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 5 inclusion and 4 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 23 Apr 2025. 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?

Postural control measures (time frame: baseline,immediate only for experimental group), and after 8 weeks.). 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 NCT06172517, which also lists 13 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 23 Apr 2025; AzTrials last refreshed its copy on 31 Oct 2026.

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