Not Yet RecruitingNot Applicable

A Multicenter, Superiority Randomized Controlled Trial of Three Interventions for Patients With a Progressive Collapsing Foot Deformity

Canada198 participantsStarted 2027-01-01

Plain-language summary

Background Progressive collapsing foot deformity (PCFD) is a painful musculoskeletal disorder leading to a progressively developing flat foot, which affects mobility and function and negatively impairs quality of life. Foot orthoses (FOs) are often prescribed to attenuate pain and improve function in patients with PCFD. However, no study has yet investigated the impact of adding FOs, whether custom (CFOs) or prefabricated (PFOs), to the usual treatment for PCFD. Thus, the primary objective of this trial will be to compare three different non-surgical interventions combining foot exercises and education with either CFOs, PFOs or sham FOs (SFOs). Methods/Design This participant-blinded multicentric superiority randomized controlled trial with three parallel groups will be conducted at the Université du Québec à Trois Rivières (UQTR) and the Center for Interdisciplinary Research in Rehabilitation and Social Integration (Cirris) in Canada. One hundred and ninety-eight participants with PCFD will be recruited via referral from physiotherapy and podiatry clinics and targeted advertising on social media. Participants will be randomized to receive CFOs, PFOs or SFOs. All groups will also receive a foot and ankle exercises program and education about their condition. They will be evaluated at four time points: baseline, 12 weeks, 24 weeks and 52 weeks. The primary outcome will be the subcategories of pain from the Foot Function Index (FFI) questionnaire. The secondary outcomes will be: foot pain and limitations (other categories of FFI, mean and maximal pain during walking for the most painful foot during the past week), self-assessed clinical progress (Global Rating Of Change), health-related quality of life (5-Level EQ-5D), gait biomechanics, fear avoidance (Fear avoidance Scale), supination resistance and ankle and hip endurance and force. Discussion This trial first aims to determine whether FOs treatment is effective, and second, whether one of the three FO interventions is more effective than the others. This trial will help guide FOs prescription recommendations for managing foot pain, function, and biomechanical outcomes in individuals with PCFD in the future.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Present with PCFD according to Myerson et al. (M. S. Myerson et al., 2020) classification * Report medial ankle or foot pain lasting six weeks or more with a pain score of ≥ 3 out of 10 on a Visual Analogue Scale (VAS) and pain to the posterior tibial tendon * Are aged 18 to 70 years, * Can walk without assistive devices (e.g., cane, walker), * Are willing to wear shoes that accommodate their FOs daily, * Are willing to minimize the use of other interventions (e.g., pain medications, physical therapy) during the trial period. * Obtain a positive result on the single and/or double heel rise test (important pain during the test or inability to perform the test). Exclusion Criteria: * Are classified as having Stage II rigid deformities according to Myerson classification, * Have a history of musculoskeletal surgery to the foot and ankle, * Present cognitive impairment, * Are currently pregnant or breastfeeding, * Have worn FOs within the past year.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Foot pain

Timeframe: From baseline to the end of follow-up at 52 weeks

Trial details

NCT IDNCT07756372

SponsorUniversité du Québec à Trois-Rivières

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01-01

Contact for this trial

Léa Tessiot

819-376-5011 lea.tessiot@uqtr.ca

View on ClinicalTrials.gov More Progressive Collapsing Foot Deformity trials