Clinical trial NCT04421794: Effects of Foot Medial Arch Electrical Stimulation on Foot Functions and Balance
Official title: Effects of One Electrical Strengthening Session on Foot Functions and Dynamic Postural Balance: a Randomised Controlled Trial in Single Blind
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Foot
Foot strength
Stability
Plantar pressure
Dynamic postural balance
Neuromuscular Electrical Stimulation
NMES
Transcutaneous Electrical Nerve Stimulation
TENS
Lead sponsor: La Tour Hospital
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Foot strength
timeFrame: Before and immediately after intervention
Secondary outcomes:
measure: Dynamic postural balance
timeFrame: Before and immediately after intervention
measure: Arch stability
timeFrame: Before and immediately after intervention
measure: Static plantar pressure distribution
timeFrame: Before and immediately after intervention
Other outcomes:
Locations:
city: Meyrin
country: Switzerland
facility: La Tour Hospital
Study officials:
affiliation: La Tour Hospital
name: Boris Gojanovic, MD
role: PRINCIPAL_INVESTIGATOR
References: