Clinical trial NCT05216692: Morphological and Functional Effects of a Foot Strengthening Protocol
Official title: Effects of a Foot Strengthening Protocol on Foot Strength, Foot Morphological Deformation and Kinetics Parameters : a Monocentric Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Strength Deficit
Lead sponsor: La Tour Hospital
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Hallux flexion strength
timeFrame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Secondary outcomes:
measure: Change in Lesser toe flexion strength
timeFrame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
measure: Change in Foot morphological deformation
timeFrame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
measure: Change in Running and walking kinetics : Time parameters
timeFrame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
measure: Change in Running and walking kinetics : Force parameters
timeFrame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
measure: Change in Running and walking kinetics : Distance parameters
timeFrame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
measure: Change in Running and walking kinetics : Stiffness parameter
timeFrame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
measure: Change in Running and walking kinetics : Frequency parameter
timeFrame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
measure: Change in Running and walking kinetics : Pressure parameter
timeFrame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Other outcomes:
measure: Change in Evertor and invertor anke muscles strength
timeFrame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
measure: Change in Plantarflexor muscles strength
timeFrame: All measures will be collected on both feet 1 week prior the treatment and 1 week after the last intervention session
Locations:
city: Meyrin
country: Switzerland
facility: Hopital de La Tour, Service de Physiothérapie
state: Geneve
Study officials:
affiliation: La Tour Hospital, Human Motion Lab
name: François Fourchet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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