Three Foot Orthosis Interventions for Progressive Collapsing Foot Deformity

ConditionProgressive Collapsing Foot Deformity

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorUniversité du Québec à Trois-Rivières

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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),

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

Customized foot orthoses
Other intervention
Individually customized bilateral 3D-printed foot orthoses will be designed from each participant's foot morphology and manufactured at UQTR using a Nylon-11 shell, with shell thickness individualized according to body mass and sex. Orthoses will incorporate a rearfoot-forefoot post (neutral, 3°, or 6° medial inclination, determined by supination resistance) and a medial heel skive (0 or 6 mm, determined by subtalar joint axis position) to provide individualized mechanical support. Participants will wear the orthoses during weight-bearing activities for 24 weeks.
Exercise
Other intervention
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.
Podiatric Education
Other intervention
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".
Sham foot orthoses
Other intervention
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.
Prefabricated foot orthoses
Other intervention
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.

Treatment groups

198 Participants

are divided into 3 treatment groups

Group A: Control GroupSham comparator 3 interventions

Group B: Customized GroupExperimental treatment 3 interventions

Group C: Prefabricated GroupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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

Time frame

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

Secondary outcomes

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

Visual Analog Scale (VAS) (from 0 to 10; 0 being no pain and 10 worst pain imaginable).

Time frame

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

Disability and activity limitation

The disability and activity limitation subscales of the Foot Function Index, each ranging from 0 to 100, will be used, with higher scores indicating greater disability or activity limitation.

Time frame

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

Global rating of change (GROC)

participants' perception of overall treatment effect will be measured using the self-reported global rating of change scale. This outcome will then be dichotomized into the categories of "effective" ("a very great deal better", "a great deal better", "a good deal better" and "moderately better") and "ineffective" ("somewhat better", "a little better", "about the same, hardly any better at all", "no change", "about the same, hardly any worse at all", "a little worse", "somewhat worse", "moderately worse", "a good deal worse", "a great deal worse" and 'a very great deal worse")

Time frame

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

Health-related quality of life

the 5-level EQ-5D (EQ-5D-5L) will be used. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant will be asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

Time frame

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

Other outcomes

Demographic and clinical data

Baseline demographic and clinical data will include gender, biological sex, age, weight, height, body mass index (calculated as weight in kg divided by height in meters squared), smoking status, alcohol consumption, highest level of education, physical activity level, and duration of pain.

Time frame

Baseline

Foot posture index

The six clinical criteria used in FPI are: 1. Palpation of the talus head (medial and lateral deviation of the talus head in relation to the navicular bone); 2. Curvature of the supra and lateral infra-maleolar region; 3. Position of the calcaneus in the frontal plane; 4. Prominence of the talonavicular region; 5. Congruence of the internal longitudinal arche; and 6. Abduction/adduction of the forefoot with respect to the rearfoot. Each criterion is rated between -2 and +2 and the sum of all gives a total score indicating the foot posture (Normal = 0 to +5; pronated = +6 to +9; highly pronated = +10 to +12; supinated = -1 to -4 and highly supinated = -5 to -12).

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Université du Québec à Trois-Rivières

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov

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