Hopital de La Tour, Service de Physiothérapie
Meyrin, Canton of Geneva, 1217, Switzerland
Completed
NCT Number: NCT05216692
Morphological and Functional Effects of a Foot Strengthening Protocol
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
La Tour Hospital Foot Strengthening Protocol
ProcedureFirst 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.
Standard Literature Foot Strengthening Protocol
ProcedureDuring 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.
Primary outcomes
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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).
Secondary outcomes
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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).
-
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.
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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.
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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.
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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.
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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.
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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.
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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.
Other outcomes
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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).
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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.
Sponsors and collaborators
Lead sponsor
François Fourchet
Other
Registry information
Official study title
Effects of a Foot Strengthening Protocol on Foot Strength, Foot Morphological Deformation and Kinetics Parameters : a Monocentric Randomized Controlled Trial
Important dates
- Study start
- 2022
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Jan 31, 2022
- Registry last updated
- Apr 20, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.