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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2022-A00376-37 |
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inclusion rate too low
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training group (PRP) | Experimental | Participants benefiting from an 8-week muscle strengthening program (PRP) |
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| Control group | Sham Comparator | Participants in the control group will be asked to maintain their habits and lifestyle (without training program) for the duration of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progressive foot strengthening protocol | Other | This interventional group will perform the foot strengthening protocol (PRP) with physical tests as :
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria :
Exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Pascal EDOUARD, PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne | Saint-Etienne | 42055 | France |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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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).
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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
| Control group | Other | The control group will not perform the foot strengthening protocol and will continue with all their daily activities with no change in lifestyle. |
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| Change from baseline to Week 18 |
| Foot posture | Foot posture will be measured using the Foot Posture Index (FPI-6). | Change from baseline to Week 18 |
| 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. | Change from baseline to Week 18 |
| 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. | Change from baseline to Week 18 |
| 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. | Change from baseline to Week 18 |
| 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. | Change from baseline to Week 18 |
| 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. | Change from baseline to Week 18 |
| D008722 | Methods |