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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Multiple Sclerosis (MS) - Relapsing-remitting; Sensorimotor Gait Disorder
• Intervention / Treatment: Other: Extracorporeal Shock Wave Therapy (ESWT)

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Elâzığ, Turkey (Türkiye), 23100
    • Fırat University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Extracorporeal Shock Wave Therapy	Other: Extracorporeal Shock Wave Therapy (ESWT); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static Postural Balance	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	From enrollment to the end of treatment at 6 weeks
Plantar Light Touch Sensitivity Threshold	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	From enrollment to the end of treatment at 6 weeks
Gait cycle duration	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.	From enrollment to the end of treatment at 6 weeks
Step length	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.	6 From enrollment to the end of treatment at 6 weeks
Cadence	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.	From enrollment to the end of treatment at 6 weeks
Single-support time	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.	From enrollment to the end of treatment at 6 weeks
Swing phase	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.	From enrollment to the end of treatment at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vibration Duration	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.	From enrollment to the end of treatment at 6 weeks
Knee Position Sense	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.	From enrollment to the end of treatment at 6 weeks

Collaborators and Investigators

• Sponsor: Furkan Bilek

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): February 15, 2025
• Study Completion (Actual): October 15, 2025

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 5, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 5, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Gait Disorders, Neurologic; Therapeutics; Physical Therapy Modalities; Rehabilitation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Extracorporeal Shockwave Therapy
• Other Study ID Numbers: 2021/08-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared with external researchers to ensure the full protection of participant privacy and to maintain confidentiality in accordance with the informed consent forms approved by the Institutional Review Board. The ethical approval obtained for this study does not include explicit permission for the public sharing of raw individual data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No