Effects of Foot Medial Arch Electrical Stimulation on Foot Functions and Balance
NCT ID: NCT04421794
Last Updated: 2021-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2020-07-01
2020-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NMES group
For the NMES group one portable stimulator (Compex 2, Medicompex SA, Ecublens, Switzerland) will deliver NEMS (15 min; 75 EMS contractions completed during the training session; rise time = 0.25 s and descending time = 0.75 s). In order to maximize muscle tension without accompanying detrimental effects on fatigue onset, biphasic symmetric regular-wave pulsed currents (85 Hz) lasting 400 μs will be delivered. Each 4-s steady tetanic stimulation will be followed by pause lasting 8-s, during which subjects will be submaximally stimulated at 4 Hz on the medial arch muscles. According to the recommendations, the two electrodes are placed behind the head of the first metatarsal to stimulate the medial arch intrinsic muscles. The goal is to attain the highest tolerable level of muscle contraction without discomfort during the 15 minutes and to provide a full tetanic contraction of the intrinsic foot muscles during the contraction time.
NMES
Neuromuscular Electrical Stimulation (NMES) is a non pharmacological intervention that sends electrical impulses to nerves leading to muscle contraction. The electrical stimulation can increase strength and is often used to re-educate or re-train muscles.
Control group
For the control group the one portable stimulator (Compex 2, Medicompex SA, Ecublens, Switzerland) will be used to apply a stimulation of 15 minutes considered by TENS at the lowest intensity detectable by the participant in order to not influence the outcomes of interest. Our aim is to strengthen IFM which is not the role of TENS. The two electrodes will be placed on the dominant foot, at the same place than those for the NMES group.
TENS
Transcutaneous electrical nerve stimulation (TENS) is a nonpharmacological intervention that activates a complex neuronal network to reduce pain by activating descending inhibitory systems in the central nervous system to reduce hyperalgesia.
Interventions
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NMES
Neuromuscular Electrical Stimulation (NMES) is a non pharmacological intervention that sends electrical impulses to nerves leading to muscle contraction. The electrical stimulation can increase strength and is often used to re-educate or re-train muscles.
TENS
Transcutaneous electrical nerve stimulation (TENS) is a nonpharmacological intervention that activates a complex neuronal network to reduce pain by activating descending inhibitory systems in the central nervous system to reduce hyperalgesia.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Fracture in the leg or in the foot that occurred during the last year
* Severe foot deformity
* Self-reported disability due to neuromuscular impairment in the lower extremity
* Neurological or vestibular impairment that affected balance (diabetes mellitus, lumbosacral radiculopathy, a soft tissue disorder such as Marfan or Ehlers-Danlos syndrome)
* Any absolute contraindication to NMES (pacemaker, seizure disorders, pregnancy)
* Experience of NMES at the foot region or foot core strengthening
18 Years
60 Years
ALL
Yes
Sponsors
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La Tour Hospital
OTHER
Responsible Party
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Boris Gojanovic
Principal Investigator
Principal Investigators
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Boris Gojanovic, MD
Role: PRINCIPAL_INVESTIGATOR
La Tour Hospital
Locations
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La Tour Hospital
Meyrin, , Switzerland
Countries
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Other Identifiers
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2020 - 00533
Identifier Type: -
Identifier Source: org_study_id
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