Morphological and Functional Effects of a Foot Strengthening Protocol

April 19, 2022 updated by: François Fourchet

Effects of a Foot Strengthening Protocol on Foot Strength, Foot Morphological Deformation and Kinetics Parameters : a Monocentric Randomized Controlled Trial

The principal aim of this study is to investigate the effects of a four-week foot strenghtening protocol combining active voluntary exercises and assisted-active voluntary exercises by neuromuscular electrical stimulation on hallux toe flexion strength in comparison to a standard foot strengthening protocol in a healthy adult recreational active population.

The secondary objectives of the study are to investigate the effects of this protocol on lesser toes flexor strength, foot morphology deformation in one, two and three dimensions and kinetic parameters when walking and running.

Study Overview

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • 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

    • Geneve
      • Meyrin, Geneve, Switzerland, 1217
        • Hopital de La Tour, Service de Physiothérapie

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

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Level of weekly physical activity (recreational activity and regular non-competitive runners : at least 1 running session per week)

Exclusion Criteria:

  • History of pain or episodes of foot or ankle sprains during the past 6 months;
  • Foot or leg fractures during the past year;
  • Severe deformity of the foot or leg;
  • Self-declared disability due to neuromuscular impairment of the lower limbs;
  • Neurological or vestibular deficit that could hinder balance (diabetes mellitus, radiculopathie lumbosacral, soft tissue disorder such as Marfan or Ehlers-Danlos syndrome) ;
  • Any absolute contraindication to neuromuscular electrical stimulation (NMES) (cardiac pacemaker, epileptic disorders, pregnancy defibrillator);
  • Participation in an exercise program specifically designed to strengthen the ankle or foot during the last 6 months

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
The foot strengthening protocol will last 4 weeks with 2 sessions per week and is composed of 3 exercises targeting forefoot and midfoot region strength as well as enhancing plyometric capabilities of the foot complex.

First exercise : "NMES forward lean doming". Doming exercise assisted by NMES placed on the IFM. 8 sec of contraction (6 sec rest) moving the trunk forward. 12 repetitions, 3 sets. Progressive increase of the intensity of NEMS during 4 weeks and increase of body load while decreasing the number of repetitions.

Second exercise : "MTP joint flexion". Isometric MTP joint flexion contractions. 4 contractions of 5 sec (10 sec rest), 3 sets. Progressive increase of the number of MVIC during 4 weeks and of increase body load while keeping the same intensity.

Third exercise : "Foot-ankle rebound". Multiple jumps with only plantar flexion. Keeping the knee stiff and straight and pushing off the ground with only ankle and MTP plantar flexion by a forefoot contact with the ground. 10 seconds of jump (1 min of rest) during 5 sets. Progressive increase of body load while keeping the same intensity.

Active Comparator: Control group
The standard literature foot strengthening protocol will last 4 weeks with 3 sessions per week and is composed of one exercise targeting the strength of the foot medial arch.

During the 1st week, the participants will perform the "Short foot exercise" (SFE) during 3 series of 10 repetitions of 5 seconds of contractions in sitting position. 1 minute of rest will be give between series.

During the 2nd week, the participants will perform the SFE during 3 series of 15 repetitions of 5 seconds of contractions in sitting position. 1 minute of rest will be give between series.

During the 3rd week, the participants will perform the SFE during 3 series of 15 repetitions of 5 seconds of contractions in standing bipedal position. 1 minute of rest will be give between series.

During the 4th week, the participants will perform the SFE during 3 series of 15 repetitions of 5 seconds of contractions in standing unipedal position. 1 minute of rest will be give between series.

The progression of the exercise during the protocol will be based on passing from a sitting position to a unipedal standing position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hallux flexion strength
Time Frame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Hallux flexion strength will be assessed by a MicroFET2 Handheld Digital Dynamometer in hook lying position. The strength will be normalized by bodyweight (N/kg).
All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lesser toe flexion strength
Time Frame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Lesser toe flexion strength will be assessed by a MicroFET2 Handheld Digital Dynamometer in hook lying position. The strength will be normalized by bodyweight (N/kg).
All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Foot morphological deformation
Time Frame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Foot morphological deformation in 1, 2 and 3 dimensions will be assessed thanks to the Arch Height Index Measurement System (AHIMS, JAKTOOL Corporation, Cranberry, NJ) by measuring the change of the total foot length, foot width, truncated foot length, dorsal arch height, navicular height measurements in a sitting position (10% of bodyweight) to a standing position (95% of bodyweight). The percentage of loading during the measurement will be checked by performing the measurement of force platform.
All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Running and walking kinetics : Time parameters
Time Frame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Running kinetic parameters when walking and running will be assessed with an instrumented treadmill (Zebris FDM-THQ, ZebrisMedicalGmbH, Germany). The variables collected will be mean contact time (s), mean flight time (s), and the duration (s) on 7-foot regions (heel 1, heel 2, midfoot, forefoot 1, forefoot 2, forefoot 3, toes) will be assessed during 40 seconds of acquisition at self-selected speed during walking and running.
All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Running and walking kinetics : Force parameters
Time Frame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Running kinetic parameters when walking and running will be assessed with an instrumented treadmill (Zebris FDM-THQ, ZebrisMedicalGmbH, Germany). The variables collected will be mean vertical force (N) and peak force (N) on 7-foot regions (heel 1, heel 2, midfoot, forefoot 1, forefoot 2, forefoot 3, toes) during 40 seconds of acquisition at self-selected speed during walking and running.
All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Running and walking kinetics : Distance parameters
Time Frame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Running kinetic parameters when walking and running will be assessed with an instrumented treadmill (Zebris FDM-THQ, ZebrisMedicalGmbH, Germany). The variables collected will be step length (cm) and step width (cm) during 40 seconds of acquisition at self-selected speed during walking and running.
All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Running and walking kinetics : Stiffness parameter
Time Frame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Running kinetic parameters when walking and running will be assessed with an instrumented treadmill (Zebris FDM-THQ, ZebrisMedicalGmbH, Germany). The variable collected will be mean kleg (Kn/m) during 40 seconds of acquisition at self-selected speed during walking and running.
All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Running and walking kinetics : Frequency parameter
Time Frame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Running kinetic parameters when walking and running will be assessed with an instrumented treadmill (Zebris FDM-THQ, ZebrisMedicalGmbH, Germany). The variable collected will be step frequency (step/min) during 40 seconds of acquisition at self-selected speed during walking and running.
All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Running and walking kinetics : Pressure parameter
Time Frame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Running kinetic parameters when walking and running will be assessed with an instrumented treadmill (Zebris FDM-THQ, ZebrisMedicalGmbH, Germany). The variable collected will be the maximal pressure (N/cm²) on 7-foot regions (heel 1, heel 2, midfoot, forefoot 1, forefoot 2, forefoot 3, toes) during 40 seconds of acquisition at self-selected speed during walking and running.
All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Evertor and invertor anke muscles strength
Time Frame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Evertor and invertor anke muscles strength will be assessed by a MicroFET2 Handheld Digital Dynamometer in supine position and with the ankle in neutral position. The strength will be normalized by bodyweight (N/kg).
All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Change in Plantarflexor muscles strength
Time Frame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Plantarflexor strength will be assessed by using the Heel-Rise Test according to previous recommendations. The maximal repetitions will be keep for the analysis.
All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session

Collaborators and Investigators

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

Investigators

  • Principal Investigator: François Fourchet, PhD, La Tour Hospital, Human Motion Lab

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

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 (Actual)

January 3, 2022

Primary Completion (Actual)

February 11, 2022

Study Completion (Actual)

February 11, 2022

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

January 27, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2021-D0041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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