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

NCT07756372 | Not Yet Recruiting

• 1 other identifier: 2026_UQTR_PCFD_RCT
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Progressive Collapsing Foot Deformity

Keywords

Foot orthoses; Gait biomechanics; Conservative treatment; Foot Function; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Foot pain

  Foot Function Index pain subscale (FFI) , compose of 9 items, scored from 0 to 100, 0 being no pain and 100 representing maximum pain and dysfunction

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

Secondary Outcomes (9)

• Mean and maximal pain during walking for the most painful foot during the past week

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

• Disability and activity limitation

  From Baseline to the end of follow-up at 52 weeks

• Global rating of change (GROC)

  From 12 weeks to the end of follow-up at 52 weeks

• Health-related quality of life

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

• Fear-Avoidance Components Scale (FACS)

  From Baseline to the end of follow-up at 52 weeks

Other Outcomes (2)

• Demographic and clinical data

  Baseline

• Foot posture index

  Baseline

Study Arms (3)

Control Group

SHAM COMPARATOR

Participants randomized to this group will receive 3D printed sham foot orthoses in combination with standardized podiatric education and a home-based progressive exercise program.

Other: Exercise; Other: Podiatric Education; Other: Sham foot orthoses

Customized Group

EXPERIMENTAL

Participants randomized to this group will receive customized 3D printed foot orthoses in combination with standardized podiatric education and a home-based progressive exercise program.

Other: Customized foot orthoses; Other: Exercise; Other: Podiatric Education

Prefabricated Group

EXPERIMENTAL

Participants randomized to this group will receive prefabricated foot orthoses covered by in combination with standardized podiatric education and a home-based progressive exercise program.

Other: Exercise; Other: Podiatric Education; Other: Prefabricated foot orthoses

Interventions

Customized foot orthoses OTHER

Individually customized bilateral 3D-printed foot orthoses will be designed from each participant's foot morphology and manufactured at UQTR using a Nylon-11 (PA11) shell. Orthoses will incorporate a 6° medially wedged forefoot-rearfoot post and a 6-mm medial heel skive to provide individualized mechanical support. Participants will wear the orthoses during weight-bearing activities for 24 weeks.

Customized Group

Exercise OTHER

Participants will complete a progressive home-based strengthening program targeting the tibialis posterior, tibialis anterior, and triceps surae muscles. The program will consist of six progressive levels prescribed by a podiatrist according to the participant's baseline clinical presentation. Exercise sessions will last approximately 30 minutes and will be performed at least four times per week for 12 weeks. Progression to the next level will occur after successful completion of four sets of 20 repetitions at the current level.

Control Group; Customized Group; Prefabricated Group

Podiatric Education OTHER

All participants will receive the same evidence-based information and clinical guidance at the start of the trial, and will follow a 7-day familiarization protocol with progressive FO wear time, starting at 1 hour per day and increasing by 1 hour daily up to 5 hours per day. Following familiarization, participants will be instructed to wear their assigned FOs during all standing activities, targeting a minimum of 5 hours per day, for the 24-week intervention period. FO-wearing instructions, the exercise program, and study information will be available at any time on the study website : "projetpied.com".

Control Group; Customized Group; Prefabricated Group

Sham foot orthoses OTHER

Participants will receive bilateral 3D-printed sham foot orthoses manufactured from low-stiffness FilaForm material. The sham orthoses will have an appearance similar to the customized orthoses but will provide negligible mechanical support, thereby maintaining participant blinding. Participants will wear the orthoses during weight-bearing activities for 24 weeks.

Control Group

Prefabricated foot orthoses OTHER

A pair of commercially available PFOs (Powerstep Pinnacle Maxx support, United States of America), in the proper size, will be provided to each participant. The top cover will be made of a polyester fabric. The structural arch support will consist of a polypropylene shell incorporating a 2° medial post. A dual-layer system composed of a black foam top layer and a black ethylene-vinyl acetate (EVA) base layer will also be included (Figure 2). An additional 1 mm black vinyl surface layer will be manually added to the PFOs to keep participants blinded to the condition they are allocated to.

Prefabricated Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université du Québec à Trois-Rivières: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Centre interdisciplinaire de recherche en réadaptation et intégration sociale (Cirris)

Québec, Quebec, G1M 2S8, Canada

Location

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G9A 5H7, Canada

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Tessiot Léa

  Université du Québec à Trois-Rivières

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Léa Tessiot

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

CA (2)