Multiple SclerosisNCT07514104
Extracorporeal Shock Wave Therapy in Enhancing Sensitivity and Postural Stability in Multiple Sclerosis
A study testing Extracorporeal Shock Wave Therapy (ESWT) in people with Multiple Sclerosis and Multiple Sclerosis (MS) - Relapsing-remitting, run by Furkan Bilek at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Sensorimotor Gait Disorder
- What is being tested?
- Extracorporeal Shock Wave Therapy (ESWT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 15 Oct 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Sensorimotor Gait Disorder
- Being tested
- Extracorporeal Shock Wave Therapy (ESWT)
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal Shock Wave Therapy | Experimental | Not described Receives: Other: Extracorporeal Shock Wave Therapy (ESWT) |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Jul 2021
- Primary completion15 Feb 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Furkan Bilek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Furkan Bilek, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514104
- Sponsor's protocol ID
- 2021/08-15
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Extracorporeal Shock Wave Therapy in Enhancing Plantar Sensitivity and Postural Stability in Multiple Sclerosis: A Quantitative Gait and Sensory Analysis
- ClinicalTrials.gov ID
- NCT07514104
- Acronym / sponsor ID
- 2021/08-15
- Conditions
- Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Sensorimotor Gait Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Furkan BilekUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 7 Apr 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal Shock Wave Therapy | Experimental | Other: Extracorporeal Shock Wave Therapy (ESWT) |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| 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 | Other | Extracorporeal Shock Wave Therapy |
Primary outcome
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
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
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.
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.
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.
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.
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.
2 secondary outcomes
Vibration Duration
Time frame: From enrollment to the end of treatment at 6 weeks
Knee Position Sense
Time frame: From enrollment to the end of treatment at 6 weeks
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 7 Apr 2026.
- Individual participant dataSharing planned: No. 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy (ESWT) in people with Multiple Sclerosis and Multiple Sclerosis (MS) - Relapsing-remitting, run by Furkan Bilek at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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 7 Apr 2026. 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 Turkey (Türkiye). 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. 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?
Static Postural Balance (time frame: From enrollment to the end of treatment at 6 weeks). The study lists 7 primary outcomes in all. 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 7 Apr 2026.