Effects of Foot Medial Arch Electrical Stimulation on Foot Functions and Balance

NCT04421794 | Completed

• 1 other identifier: 2020 - 00533
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the immediate effects of sole session of foot medial arch' NMES on foot strength, arch stability, static plantar pressure distribution and dynamic postural balance.

Conditions

Healthy

Keywords

Foot; Foot strength; Stability; Plantar pressure; Dynamic postural balance; Neuromuscular Electrical Stimulation; NMES; Transcutaneous Electrical Nerve Stimulation; TENS

Outcome Measures

Primary Outcomes (1)

• Foot strength

  The change of foot strength that will be measured on a pressure platform on the dominant foot before and after intervention (NMES or TENS). This primary outcome will be also measured on the non-dominant foot to assess cross effects.

  Before and immediately after intervention

Secondary Outcomes (3)

• Dynamic postural balance

  Before and immediately after intervention

• Arch stability

  Before and immediately after intervention

• Static plantar pressure distribution

  Before and immediately after intervention

Study Arms (2)

NMES group

EXPERIMENTAL

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.

Device: NMES

Control group

PLACEBO COMPARATOR

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.

Device: TENS

Interventions

NMES DEVICE

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.

NMES group

TENS DEVICE

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.

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Foot Posture Index (FPI) between +6 à +12 (slight pronation / increased pronation)

You may not qualify if:

• History of ankle or foot sprain or pain within the last 3 months
• 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

Sponsors & Collaborators

• La Tour Hospital: lead

Study Sites (1)

La Tour Hospital

Meyrin, 1217, Switzerland

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Boris Gojanovic, MD

  La Tour Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This randomised controlled trial is in single blind. Participants will be informed about their treatment group after termination of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be allocated to the intervention or control group using permuted block randomization with blocks of 4 or 6 patients on a 1:1 ratio.

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: July 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: October 30, 2020
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)