Effects of One Electrical Strengthening Session on Foot Functions and Dynamic Postural Balance: a Randomised Controlled Trial in Single Blind
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Foot strength
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
This randomised controlled trial is in single blind. Participants will be informed about their treatment group after termination of the study.
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Dynamic postural balance(Before and immediately after intervention)
- Arch stability(Before and immediately after intervention)
- Static plantar pressure distribution(Before and immediately after intervention)
Investigators
Boris Gojanovic
Principal Investigator
La Tour Hospital