Effects of Foot Medial Arch Electrical Stimulation on Foot Functions and Balance
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|ClinicalTrials.gov Identifier: NCT04421794|
Recruitment Status : Not yet recruiting
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Device: NMES Device: TENS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking Description:||This randomised controlled trial is in single blind. Participants will be informed about their treatment group after termination of the study.|
|Official Title:||Effects of One Electrical Strengthening Session on Foot Functions and Dynamic Postural Balance: a Randomised Controlled Trial in Single Blind|
|Estimated Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||October 2020|
Experimental: 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.
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.
Placebo Comparator: 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.
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.
- Foot strength [ Time Frame: Before and immediately after intervention ]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.
- Dynamic postural balance [ Time Frame: Before and immediately after intervention ]The secondary outcomes include the change of dynamic postural balance in the posterior direction on the dominant foot. All measurements will be performed on the non-dominant foot to assess cross effects. To assess dynamic postural balance performance, we will use the Star Excursion Balance Test (SEBT). The star excursion balance test (SEBT) is a measure of dynamic balance with good to excellent test-retest reliability. The test will be conducted in the anterior, posterior-lateral and posterior-medial directions. The SEBT will be performed with the subject standing barefoot so that the distal end of the longest toe of the stance foot will be placed at the center of the grid. They will have to maintain a single-leg stance while reaching with the contralateral leg to touch as far as possible along the direction by a light touch. The reached distances will be normalized to the respective stance-limb length (anterior superior iliac spine to the inferior border of the medial malleolus).
- Arch stability [ Time Frame: Before and immediately after intervention ]The secondary outcomes include the change of arch stability on the dominant foot. This measurement will be performed on the non-dominant foot to assess cross effects. The sit-to-stand double-leg navicular drop test will be used to evaluate longitudinal arch stability. Participants will sit on a chair with their hips, knees, and ankles bent to 90° and the feet resting on the floor. The inferior border of the prominent tuberosity of the navicular bone will be palpated and marked with a pen. Next, the distance of the marked navicular point to the ground in a seated position will be measured using a steel ruler (resolution: 0.5 mm). Then, we will ask the subject to stand barefoot on a 4-in (10.16-cm) box, placing all weight on the foot being measured, while the other foot rested lightly on the box. Finally, the difference between the two measures (sitting - standing) will be calculated and defined as navicular drop (ND).
- Static plantar pressure distribution [ Time Frame: Before and immediately after intervention ]
The secondary outcomes include the change of arch stability on the dominant foot. In this study the evaluation of the longitudinal arch of the foot will be made with the use of the Zebris FDM-S dynamometric platform. It will describe foot arch assessment based on the AI calculated on the basis of discretized measurements of distribution of forces on the ground, by means of the platform.
According to this theory, a static arch pressure index (SAPI) will be measured by utilizing the average/maximal foot pressure distribution during static single leg standing of 30 seconds with their arms along the body while the subject will have one foot on a Zebris platform. Based on distribution of pressure on the entire foot the SAPI will be calculate as the ratio of the midfoot pressure distribution relative to the whole foot pressure distribution excluding the toes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04421794
|Contact: Boris Gojanovic, MDfirstname.lastname@example.org|
|Contact: Francois Fourchet, PT, PhD, DO||+41 22 719 67 email@example.com|
|Principal Investigator:||Boris Gojanovic, MD||La Tour Hospital|