Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Sensorimotor Gait Disorder
Conditions
Brief 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). 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.
Interventions
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
Sponsors
Furkan Bilek
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Static Postural Balance | 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 | 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 | 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Vibration Duration | 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. |
| Knee Position Sense | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed