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Completed

NCT Number: NCT07514104

Extracorporeal Shock Wave Therapy in Enhancing Sensitivity and Postural Stability in Multiple Sclerosis

This randomized controlled trial aimed to investigate the efficacy of Extracorporeal Shock Wave Therapy (ESWT) on plantar somatosensory function, knee joint proprioception, and spatiotemporal gait parameters in individuals diagnosed with Multiple Sclerosis (MS). The study included participants with a spasticity level below 1+, with the intervention group receiving ESWT three times per week over a 6-week period. To evaluate sensory changes, light touch thresholds were measured at six plantar sites-the heel, medial longitudinal arch, 1st and 5th metatarsal heads, and the 1st and 5th toes-using the Semmes-Weinstein monofilament kit. Additionally, two-point discrimination was assessed at the heel, and vibration duration was measured at the metatarsal heads using a 128 Hz tuning fork. Proprioception was quantified via the active knee joint reposition test in a closed kinetic chain position, measuring the absolute angular error at a 60° target angle. Postural stability and dynamic gait were objectively analyzed using the Win-Track platform and a reliable 3-step protocol to record parameters such as gait cycle duration, step length, cadence, and maximum plantar pressure. Static balance was further evaluated by recording the percentage of body weight transferred to each foot. By targeting both mechanoreceptor sensitivity and joint position sense, this 6-week ESWT intervention seeks to enhance the overall functional mobility and stability of MS patients.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Gait Disorders, Neurologic Immune System Diseases Multiple Sclerosis (MS) - Relapsing-remitting Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensorimotor Gait Disorder Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fırat University

Elâzığ, 23100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Multiple Sclerosis
  • Spasticity level below 1+ according to the Modified Ashworth Scale
  • Ability to walk independently or with assistive devices to perform the 3-step gait protocol
  • Willingness to participate in a 6-week intervention involving bilateral plantar ESWT
  • Stable medical condition without a recent relapse within the last 3 months

Exclusion criteria

  • Presence of severe cognitive impairment that prevents following test instructions
  • Other neurological disorders (e.g., Parkinson's disease, polyneuropathy) that could interfere with sensory or gait assessments
  • Presence of open wounds, active infections, or skin integrity issues on the plantar surface of the feet
  • Contraindications for Extracorporeal Shock Wave Therapy

Treatment and study plan

Extracorporeal shock wave therapy (ESWT)

Other

The study group received bilateral Extracorporeal Shock Wave Therapy (ESWT) applied to the plantar surface of both feet. The intervention was administered three times per week for a total duration of 6 weeks. The primary goal of this bilateral application was to modulate sensory thresholds and enhance postural stability by stimulating mechanoreceptors across the entire weight-bearing surface of the feet

Primary outcomes

  1. Static Postural Balance

    Time frame: From enrollment to the end of treatment at 6 weeks

    Static balance analysis was performed using the Win-Track platform while participants stood barefoot with arms at their sides. The percentage (%) of body weight transferred to each foot was recorded to assess postural stability and symmetry

  2. Plantar Light Touch Sensitivity Threshold

    Time frame: From enrollment to the end of treatment at 6 weeks

    The Semmes-Weinstein monofilament kit was used to evaluate light touch sensation on the soles of both feet. Eight monofilament levels were applied to the heel, medial longitudinal arch, 1st and 5th metatarsal heads, and the 1st and 5th toes. The average of the thresholds from these six plantar sites was recorded, where higher thresholds indicate lower sensitivity

  3. Gait cycle duration

    Time frame: From enrollment to the end of treatment at 6 weeks

    The Win-Track platform (MEDICAPTEURS Technology, France) was used to measure gait parameters during barefoot walking using a 3-step protocol. Parameters include gait cycle duration (sec). This provides quantitative information about the patient's dynamic gait efficiency.

  4. Step length

    Time frame: 6 From enrollment to the end of treatment at 6 weeks

    The Win-Track platform (MEDICAPTEURS Technology, France) was used to measure gait parameters during barefoot walking using a 3-step protocol. Parameters include step length (cm). This provides quantitative information about the patient's dynamic gait efficiency.

  5. Cadence

    Time frame: From enrollment to the end of treatment at 6 weeks

    The Win-Track platform (MEDICAPTEURS Technology, France) was used to measure gait parameters during barefoot walking using a 3-step protocol. Parameters include cadence (steps/min). This provides quantitative information about the patient's dynamic stability and gait efficiency.

  6. Single-support time

    Time frame: From enrollment to the end of treatment at 6 weeks

    The Win-Track platform (MEDICAPTEURS Technology, France) was used to measure gait parameters during barefoot walking using a 3-step protocol. Parameters include single-support time(Sec). This provides quantitative information about the patient's dynamic stability and gait efficiency.

  7. Swing phase

    Time frame: From enrollment to the end of treatment at 6 weeks

    The Win-Track platform (MEDICAPTEURS Technology, France) was used to measure gait parameters during barefoot walking using a 3-step protocol. Parameters include swing phase (Sec). This provides quantitative information about the patient's dynamic stability and gait efficiency.

Secondary outcomes

  1. Vibration Duration

    Time frame: From enrollment to the end of treatment at 6 weeks

    A 128 Hz tuning fork was used to measure the duration that vibration is perceived on the heads of the 1st and 5th metatarsals. A chronometer measured the time until the participant could no longer feel the vibration.

  2. Knee Position Sense

    Time frame: From enrollment to the end of treatment at 6 weeks

    Knee position sense was assessed using the active joint reposition test in a closed kinetic chain position with a Digital Inclinometer. Participants squatted to a target angle of 60° and attempted to reproduce it. The difference between the target angle and the reproduced angle was recorded as the absolute angular error in degrees.

Sponsors and collaborators

Lead sponsor

Furkan Bilek

Other

Registry information

Official study title

Efficacy of Extracorporeal Shock Wave Therapy in Enhancing Plantar Sensitivity and Postural Stability in Multiple Sclerosis: A Quantitative Gait and Sensory Analysis

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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