HealthyNCT04421794
Effects of Foot Medial Arch Electrical Stimulation on Foot Functions and Balance
A study testing NMES and TENS in people with Healthy, run by La Tour Hospital at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- NMES and TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2020to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Foot Posture Index (FPI) between +6 à +12 (slight pronation / increased pronation)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of One Electrical Strengthening Session on Foot Functions and Dynamic Postural Balance: a Randomised Controlled Trial in Single Blind
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.
Read the detailed description
The study design is a randomised controlled trial in population with pronated feet. 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. This is the 2nd study to investigate the effect one session as previous study showed immediate effect on plantar pressure distribution on the midfoot and durable effect at 2 months follow-up. However, no studies investigated the effects on others parameters than plantar pressure.The general objective of our study is to question electrical stimulation as a modality for foot strengthening to enhance dynamic postural balance and foot functions.
- Conditions
- Healthy
- Being tested
- NMES, TENS
- Keywords
- Foot, Foot strength, Stability, Plantar pressure, Dynamic postural balance, Neuromuscular Electrical Stimulation, NMES, Transcutaneous Electrical Nerve Stimulation, TENS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMESDevice
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.
TENSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and immediately after intervention
Secondary outcomes (3)
Dynamic postural balance
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).
Measured: Before and immediately after intervention
Arch stability
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).
Measured: Before and immediately after intervention
Static plantar pressure distribution
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.
Measured: Before and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jul 2020
- Primary completion30 Sep 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- La Tour Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boris Gojanovic, La Tour Hospital
- Investigators
- Boris Gojanovic, MD, Principal investigator, La Tour Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421794
- Sponsor's protocol ID
- 2020 - 00533
- Status last verified
- Feb 2021
- First submitted
- 4 Jun 2020
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of One Electrical Strengthening Session on Foot Functions and Dynamic Postural Balance: a Randomised Controlled Trial in Single Blind
- ClinicalTrials.gov ID
- NCT04421794
- Acronym / sponsor ID
- 2020 - 00533
- Conditions
- Healthy
- Keywords
- Foot, Foot strength, Stability, Plantar pressure, Dynamic postural balance, Neuromuscular Electrical Stimulation, NMES, Transcutaneous Electrical Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- La Tour HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study design is a randomised controlled trial in population with pronated feet. 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. This is the 2nd study to investigate the effect one session as previous study showed immediate effect on plantar pressure distribution on the midfoot and durable effect at 2 months follow-up. However, no studies investigated the effects on others parameters than plantar pressure.The general objective of our study is to question electrical stimulation as a modality for foot strengthening to enhance dynamic postural balance and foot functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| NMES group | Experimental | Device: NMESFor 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. |
| Control group | Placebo comparator | Device: TENSFor 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Foot Posture Index (FPI) between +6 à +12 (slight pronation / increased pronation)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMESNeuromuscular 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. | Device | NMES group |
| TENSTranscutaneous 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. | Device | Control group |
Primary outcome
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.
3 secondary outcomes
Dynamic postural balance
Time frame: Before and immediately after intervention
Arch stability
Time frame: Before and immediately after intervention
Static plantar pressure distribution
Time frame: Before and immediately after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris Gojanovic, MD principal investigator
La Tour Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES and TENS in people with Healthy, run by La Tour Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot strength (time frame: Before and immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.