Efficacy of a Foot Strengthening Protocol on Sport Performance Kinetics (PRP-Pied-PERF)
Primary Purpose
Healthy Athletes, Healthy Volonteers
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Progressive foot strengthening protocol
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Athletes focused on measuring Foot strength, resistance training, kinetics,, sprinting, cutting, jumping, sport performance
Eligibility Criteria
Inclusion criteria :
- To be affiliated in the federation of one of the following sports : soccer, handball, rugby, basketball or track and field;
- To practice their respective sport more than two times per week;
- Be affiliated or beneficiary of a social security insurance;
- Having freely given their written consent after having been informed of the purpose, the procedure and the potential risks involved.
Exclusion criteria :
- Use of pharmacological therapy to match gander identity;
- Have an abnormal range of motion of the toes and/or ankle;
- Have any kind of ankle or foot pain (self-defined and self-reported by the FAAM questionnaire) in the previous 6 months;
- Have a previous injury or surgery of the lower limb in the previous 6 months;
- Have a neurological or vestibular deficit that may affect walking or balance (lumbar-sacral radiculopathy, peripheral nerve pathology, Marfan or Eehlers-Danlos syndrome, etc.);
- Have contraindication to neuromuscular electrical stimulation (pacemaker, seizure disorders, pregnancy);
- Have a previous foot strengthening experience in the past 6 months for at least 2 weeks and more than one session per week;
- Participate at the same time in another medical interventional experiment or have participated in such a study in the 30 days preceding this study;
- Being unable to understand the purpose and conditions of the study, and to give consent;
- Being deprived of liberty or under guardianship.
Sites / Locations
- CHU de Saint-EtienneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Training group (PRP)
Control group
Arm Description
Participants benefiting from an 8-week muscle strengthening program (PRP)
Participants in the control group will be asked to maintain their habits and lifestyle (without training program) for the duration of the study.
Outcomes
Primary Outcome Measures
maximal isometric joint flexion muscle strength MTP (in N)
It will be measured using an ergometer composed of a 3-dimensional force sensor (Nano 25, ATI Industrial Automation, Garner, NC) during the 3 periods of the randomized controlled trial (control, intervention and follow-up) and repeatedly each week during the intervention protocol.
Secondary Outcome Measures
Foot deformity
It's a composite outcome :
Foot deformity will be assessed with the help of the system (Arch Height Index Measurement System, JAKTOOL Corporation, Cranberry, NJ) measuring the following variables (in cm): height of the navicular, total length of the foot, truncated length of the foot, width of the medial foot and height of the dorsal arch when the participant is sitting and then when standing on one foot.
Foot posture
Foot posture will be measured using the Foot Posture Index (FPI-6).
Morphology of the foot muscles
The morphology of the foot muscles will be evaluated by measuring with the AixPlorer Ultrasonic scanner, version 6.1.1; Supersonic Imagine, Aix-en-Provence, France.
general stiffness of the foot-ankle complex
The general stiffness of the foot-ankle complex will be evaluated using an optical measurement system (Optojump Next, Microgate, Bolzano, 113 Italy) during 6 maximal jumps with knees stretched.
propulsion impulse during sprinting
The propulsion impulse during sprinting will be evaluated using 6 force platforms embedded in the ground (Kistler, Winterhur, Switzerland) allowing to collect kinetic parameters of forces in the 3 dimensions of space at a sampling frequency of 2000 Hz.
propulsion impulse during jumps
The propulsion impulse during jumps will be evaluated using 2 force platforms embedded in the ground under each foot (Kistler, Winterhur, Switzerland) to collect kinetic force parameters in all 3 spatial dimensions during vertical and horizontal jumps at a sampling frequency of 2000 Hz.
propulsion impulse during direction changes
The propulsion impulse during direction changes will be evaluated using a ground embedded force platform (Kistler, Winterhur, Switzerland) to collect force kinetic parameters in all 3 spatial dimensions during 90° direction changes at a sampling rate of 2000 Hz.
Full Information
NCT ID
NCT05574322
First Posted
October 3, 2022
Last Updated
April 12, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT05574322
Brief Title
Efficacy of a Foot Strengthening Protocol on Sport Performance Kinetics
Acronym
PRP-Pied-PERF
Official Title
Efficacy of a Foot Strengthening Protocol on Sport Performance Kinetics
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This randomized controlled trial aims to explore the effect of a foot strengthening protocol on toe flexion strength, foot deformation and morphology as well as kinetics during sprinting, cutting and jumping in healthy athletes (18-40 completed years). The study consists of a 4 weeks control period, followed by 8 weeks intervention period and 4 weeks follow up
Detailed Description
During the first period participants are unaware of their allocation, while in the intervention period they will be allocated to a train intervention or a control group (habits maintenance). The primary outcome is the toes maximal voluntary isometric plantarflexion. The treatment effectiveness estimand is the same as in a pretest-posttest case control study, considering the end of the control period as pre-point. An estimation of the individual variability in response to the treatment will be provided.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Athletes, Healthy Volonteers
Keywords
Foot strength, resistance training, kinetics,, sprinting, cutting, jumping, sport performance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a single-center randomized controlled trial (RCT) in 2 parallel groups of athletic participants (18-40 years) in good general health: one receiving an 8-week muscle strengthening program (PRP group), the other not (control group) strengthening program (PRP group), the other not (control group).
Masking
Participant
Masking Description
The RCT is divided into 3 distinct periods (see study diagram in Appendix 1): a 4-week control period, an 8-week intervention period and a 4-week follow-up period. This 3-period experimental design was designed to was designed to reduce various methodological biases
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Training group (PRP)
Arm Type
Experimental
Arm Description
Participants benefiting from an 8-week muscle strengthening program (PRP)
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Participants in the control group will be asked to maintain their habits and lifestyle (without training program) for the duration of the study.
Intervention Type
Other
Intervention Name(s)
Progressive foot strengthening protocol
Intervention Description
This interventional group will perform the foot strengthening protocol (PRP) with physical tests as :
Maximum muscle strength of the foot
Foot muscle morphology
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
The control group will not perform the foot strengthening protocol and will continue with all their daily activities with no change in lifestyle.
Primary Outcome Measure Information:
Title
maximal isometric joint flexion muscle strength MTP (in N)
Description
It will be measured using an ergometer composed of a 3-dimensional force sensor (Nano 25, ATI Industrial Automation, Garner, NC) during the 3 periods of the randomized controlled trial (control, intervention and follow-up) and repeatedly each week during the intervention protocol.
Time Frame
Change from baseline to Week 18
Secondary Outcome Measure Information:
Title
Foot deformity
Description
It's a composite outcome :
Foot deformity will be assessed with the help of the system (Arch Height Index Measurement System, JAKTOOL Corporation, Cranberry, NJ) measuring the following variables (in cm): height of the navicular, total length of the foot, truncated length of the foot, width of the medial foot and height of the dorsal arch when the participant is sitting and then when standing on one foot.
Time Frame
Change from baseline to Week 18
Title
Foot posture
Description
Foot posture will be measured using the Foot Posture Index (FPI-6).
Time Frame
Change from baseline to Week 18
Title
Morphology of the foot muscles
Description
The morphology of the foot muscles will be evaluated by measuring with the AixPlorer Ultrasonic scanner, version 6.1.1; Supersonic Imagine, Aix-en-Provence, France.
Time Frame
Change from baseline to Week 18
Title
general stiffness of the foot-ankle complex
Description
The general stiffness of the foot-ankle complex will be evaluated using an optical measurement system (Optojump Next, Microgate, Bolzano, 113 Italy) during 6 maximal jumps with knees stretched.
Time Frame
Change from baseline to Week 18
Title
propulsion impulse during sprinting
Description
The propulsion impulse during sprinting will be evaluated using 6 force platforms embedded in the ground (Kistler, Winterhur, Switzerland) allowing to collect kinetic parameters of forces in the 3 dimensions of space at a sampling frequency of 2000 Hz.
Time Frame
Change from baseline to Week 18
Title
propulsion impulse during jumps
Description
The propulsion impulse during jumps will be evaluated using 2 force platforms embedded in the ground under each foot (Kistler, Winterhur, Switzerland) to collect kinetic force parameters in all 3 spatial dimensions during vertical and horizontal jumps at a sampling frequency of 2000 Hz.
Time Frame
Change from baseline to Week 18
Title
propulsion impulse during direction changes
Description
The propulsion impulse during direction changes will be evaluated using a ground embedded force platform (Kistler, Winterhur, Switzerland) to collect force kinetic parameters in all 3 spatial dimensions during 90° direction changes at a sampling rate of 2000 Hz.
Time Frame
Change from baseline to Week 18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria :
To be affiliated in the federation of one of the following sports : soccer, handball, rugby, basketball or track and field;
To practice their respective sport more than two times per week;
Be affiliated or beneficiary of a social security insurance;
Having freely given their written consent after having been informed of the purpose, the procedure and the potential risks involved.
Licensed in a tennis club (FFT) and in a volleyball club (FFVolley)
Exclusion criteria :
Use of pharmacological therapy to match gander identity;
Have an abnormal range of motion of the toes and/or ankle;
Have any kind of ankle or foot pain (self-defined and self-reported by the FAAM questionnaire) in the previous 6 months;
Have a previous injury or surgery of the lower limb in the previous 6 months;
Have a neurological or vestibular deficit that may affect walking or balance (lumbar-sacral radiculopathy, peripheral nerve pathology, Marfan or Eehlers-Danlos syndrome, etc.);
Have contraindication to neuromuscular electrical stimulation (pacemaker, seizure disorders, pregnancy);
Have a previous foot strengthening experience in the past 6 months for at least 2 weeks and more than one session per week;
Participate at the same time in another medical interventional experiment or have participated in such a study in the 30 days preceding this study;
Being unable to understand the purpose and conditions of the study, and to give consent;
Being deprived of liberty or under guardianship.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pascal EDOUARD, PhD
Phone
(0)4 77 12 79 85
Ext
+33
Email
pascal.edouard@univ-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Florence RANCON, CRA
Phone
(0)477829458
Ext
+33
Email
florence.rancon@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal EDOUARD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Saint Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal EDOUARD, PhD
First Name & Middle Initial & Last Name & Degree
Clément FOSCHIA, MD
First Name & Middle Initial & Last Name & Degree
Marine SORG, MD
First Name & Middle Initial & Last Name & Degree
Pascal EDOUARD, PhD
First Name & Middle Initial & Last Name & Degree
David HUPIN, MD
First Name & Middle Initial & Last Name & Degree
Léonard FEASSON, PhD
12. IPD Sharing Statement
Learn more about this trial
Efficacy of a Foot Strengthening Protocol on Sport Performance Kinetics
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