The CurePPaC Study - Analysing Non-surgical Treatment Strategies to Cure Pes Planovalgus Associated Complaints

October 25, 2017 updated by: Heiner Baur (PhD), Bern University of Applied Sciences
Pes planovalgus, also called flat foot, is a common foot deformity characterized by a flattening of the foot's longitudinal arch and is accompanied by a dysfunction of the posterior tibial tendon ("posterior tibial tendon dysfunction" or "PTTD"). Early stages of this pathology are thought to be treated with non-surgical therapy options like foot orthoses (relief of tendon stress by mechanical unloading of the arch), strengthening exercises or basic physiotherapeutic measures. Recent literature clearly states the urgent need for high quality studies to evaluate the proposed non-surgical treatments (Bowring 2009, 2010). There is only one high quality study available that shows benefits of orthoses therapy and exercise (Kulig 2009). No study to date evaluated functional changes pre-post in dynamic movement pattern like gait or stair climbing. The widespread use of several non-surgical treatment strategies lead to extensive financial expenses of the health care system. An optimized therapeutic strategy could eventually lead to more efficient health care investments. The presented proposal addresses this latest knowledge and aims to analyse non-surgical treatment strategies to Cure Pes Planovalgus associated Complaints (CurePPaC) in the CurePPaC Study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Introduction: Pes planovalgus or flatfoot-associated complaints are frequent symptoms, which are thought to be caused by the foot deformity itself. Concurrently, the multifactorial weakness of the M. tibialis posterior and its tendon (trauma, systemic disease, chronic tendon degeneration by overuse) can lead to a flattening of the medial longitudinal arch of the foot. Affected patients suffer from functional impairment and pain. Less severe cases are eligible for non-surgical treatment. Foot orthoses are considered to be the first line approach. Furthermore strengthening of the arch and ankle stabilizing muscles are thought to contribute to an active compensation of the deformity. There is only limited evidence concerning the numerous therapy approaches since high quality studies are missing. One excellent report (Kulig et al. 2009) shows clear benefits by the use of foot orthoses and eccentric strengthening exercises. Beside the fact that evidence-based guidelines for therapy have yet to be developed, no data is available showing functional benefits that accompany the therapy process. This would give further insight into mechanisms behind non-surgical management strategies and how patients benefit functionally from therapy. Purpose: The purpose of this randomized longitudinal intervention study is the evaluation of the therapeutic benefit of three different non-surgical treatment regimens (foot orthoses only FOO, foot orthoses and eccentric exercise FOE, foot orthoses sham treatment FOS) in patients with Pes planovalgus and accompanying complaints. Furthermore the analysis of possible functional changes in gait mechanics (kinematic and kinetic view) and neuromuscular control (electromyographic analysis) will contribute to a superior understanding of functional changes that accompany non-operative management. The purpose of the study is to optimize non-surgical management in patients suffering from Pes planovalgus associated pain leading to an efficient use of health care system's financial resources. Methods: 60 patients with Pes planovalgus associated complaints (clinical diagnosis with plain weight bearing radiographs), M. tibialis posterior dysfunction) are included in the study. Functional impairment is evaluated pre and post intervention by the Foot-Function-Index (FFI, German version). Anthropometric data recording is followed by preparation of subject's foot anatomical landmarks with retroreflective markers and superficially detectable muscles of the ankle joint complex are prepared with surface electromyography (SEMG) electrodes. The 3D kinematic data allows inter alia the calculation of segmental angels of the lower extremity and measurement of navicular drop. The neuromuscular activity is analysed in the time (on-off pattern) and amplitude domain (gait cycle specific phases). Procedure: Potential participants are recruited via the Outpatient Clinic of the Department of Orthopaedic Surgery of the Inselspital, University Hospital, Bern. After initial screening, subjects are randomized to one of three intervention groups (foot orthoses only FOO, foot orthoses and eccentric exercise FOE, foot orthoses sham treatment FOS). FOO-subjects wear custom-made foot orthoses only. FOE-subjects wear individually accustomed foot orthoses and they will perform a combined monitored and home training program to progressively strengthen the M. tibialis posterior and accompanying ankle stabilizing muscles with eccentric exercises. FOS-subjects wear custom-made sham foot orthoses without the functional elements of the treatment orthoses (longitudinal arch support, ankle stabilizer, bowl-shaped heel for rearfoot stability). Subjects are measured pre and post intervention (12 weeks). Measurements include the primary outcome measure Foot-Function-Index (FFI, German version: total score) followed by basic anthropometric measures. Subject preparation allows then the measurement of 10 trials on a walkway and on stairs with embedded force plates in barefoot condition. An average step cycle out of 10 trials is calculated and biomechanical outcome measures are extracted. A re-test allows the calculation of intervention effects by one-factor ANOVA (group: treatment FOO vs. FOE vs. FOS) for repeated measures.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3001
        • Spital Netz Bern Ziegler
      • Bern, Switzerland, 3006
        • Klinik Sonnenhof Bern
      • Bern, Switzerland, 3012
        • Inselspital, University Hospital Bern
      • Bern, Switzerland, 3013
        • Salem Spital Bern
      • Bern, Switzerland, 3013
        • Salem-Spital Orthopädische Klinik Bern
      • Thun, Switzerland, 3600
        • Spital STS AG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 18-60
  • Current complaint of foot and ankle pain that lasted for 3 months or more
  • Flexible Pes planovalgus deformity in the clinical assessment
  • Posterior tibial tendon dysfunction (PTTD) of stage I and II (Johnson & Strom 1989)
  • Pes planovalgus foot deformity with longitudinal arch flattening verified by radiograph (Younger 2005): Lateral view: lateral talo-first metatarsal angle ≠ 0° (break of axis): angle >10° according to Younger (2005); 60Anteroposterior view: anteroposterior talo-first metatarsal angle ≠ 0° (break of axis): angle >10° according to Younger (2005)
  • "too-many toes"-sign from rear frontal view with an abducted forefoot (Johnson & Strom 1989, Kulig 2009b)
  • Eligibility for non-surgical treatment
  • No indication / not yet an indication for surgical treatment of foot deformity

Exclusion Criteria:

  • Rigid foot deformity
  • Posterior tibial tendon dysfunction (PTTD) of stage III and IV according to Johnson & Strom 1989 (=>rigid foot deformity)
  • Cardio-, neuro-, or peripheral vascular pathology, musculoskeletal pathology, acute infection or alcohol addiction limiting participation in study protocol
  • Acute use of local or systemic analgesics
  • Acute physical therapy, training therapy or physiotherapy
  • Acute overuse or traumatic injury to the lower leg (excluding Pes planovalgus associated pathology)
  • Prior surgery to the lower limb

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Foot Orthoses Only
including Patient Education; Abbreviation: FOO
Device: Foot Orthoses Only
patients wear foot orthoses as a treatment condition - no further therapy
Experimental: Foot Orthoses and Eccentric Exercise
including Patient Education; Abbreviation: FOE
Procedure: Foot Orthoses and Eccentric Exercise
patients wear foot orthoses and they perform an additional home-based eccentric training program for the M. tibialis posterior
Sham Comparator: Sham Foot Orthoses
including Patient Education; Abbreviation: FOS
Device: Sham Foot Orthoses
patient wear sham foot orthoses (control condition)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Foot Function Index - total score
Time Frame: change from baseline (pre intervention) to week 12 (post intervention)
additional analysis of change from baseline to week 4, and analysis of change from baseline to week 8
change from baseline (pre intervention) to week 12 (post intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Foot Function Index - subcategory pain
Time Frame: change from baseline (pre intervention) to week 12 (post intervention)
additional analysis of change from baseline to week 4, and analysis of change from baseline to week 8
change from baseline (pre intervention) to week 12 (post intervention)
Foot Function Index - subcategory disability
Time Frame: change from baseline (pre intervention) to week 12 (post intervention)
additional analysis of change from baseline to week 4, and analysis of change from baseline to week 8
change from baseline (pre intervention) to week 12 (post intervention)
Foot Function Index - subcategory activity limitation
Time Frame: change from baseline (pre intervention) to week 12 (post intervention)
additional analysis of change from baseline to week 4, and analysis of change from baseline to week 8
change from baseline (pre intervention) to week 12 (post intervention)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Disability Index
Time Frame: change from baseline (pre intervention) to week 12 (post intervention)
additional analysis of change from baseline to week 4, and analysis of change from baseline to week 8
change from baseline (pre intervention) to week 12 (post intervention)
Visual Analogue Scale
Time Frame: change from baseline (pre intervention) to week 12 (post intervention)
assessing pain pre- and post biomechanical testing / change from baseline to week 12
change from baseline (pre intervention) to week 12 (post intervention)
kinematic data from 3d movement analysis
Time Frame: change from baseline (pre intervention) to week 12 (post intervention)
regarding distance: navicular drop; regarding angular data (angle at initial contact, max. manifestation during stance, range): foot progression angle, forefoot to rearfoot dorsiflexion, forefoot to rearfoot adduction, forefoot to rearfoot supination, ankle dorsiflexion, ankle adduction, ankle eversion, knee flexion, knee adduction, knee internal rotation, hip flexion, hip adduction, hip internal rotation
change from baseline (pre intervention) to week 12 (post intervention)
neuromuscular activity
Time Frame: change from baseline (pre intervention) to week 12 (post intervention)
EMG of M. tibialis anterior, M. peroneus longus, M. gastrocnemius lateralis/medialis, M. soleus: onset of activation, time of maximum activation, total time of activation, normalized amplitude in preactivation, normalized amplitude in weight acceptance, normalized amplitude in mid-stance, normalized amplitude in push-off
change from baseline (pre intervention) to week 12 (post intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bern University of Applied Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital Inselspital, Berne
Swiss National Science Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heiner Baur, PhD, Bern University of Applied Sciences, Switzerland
  • Principal Investigator: Heiner Baur, PhD, Bern University of Applied Sciences, Health, aR&D Physiotherapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 25, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 25, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 140928

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings