Effect of Extracorporeal Shock Wave Therapy on Spasticity and Mobility in Stroke Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIstanbul Medipol University Hospital
About this trial
This study aims to evaluate the effectiveness of extracorporeal shock wave therapy (ESWT) in individuals with lower limb spasticity following stroke. Spasticity is a common complication after stroke and can negatively affect walking ability, mobility, and quality of life.
Participants will be randomly assigned to one of two groups. Both groups will receive a standard physiotherapy and rehabilitation program. In addition, the intervention group will receive ESWT applied to the lower limb muscles, while the control group will receive a sham (placebo) ESWT application.
The treatment program will be conducted three times per week for four weeks. Clinical assessments will be performed at baseline, after treatment, and during follow-up.
The main outcomes of the study include muscle tone (spasticity), walking performance, motor function, and quality of life. The results of this study may help improve rehabilitation strategies and provide evidence for the use of ESWT in stroke patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18-65 years
Diagnosed with ischemic or hemorrhagic stroke at least 3 months prior to enrollment Presence of lower extremity spasticity with a Modified Ashworth Scale (MAS) score ≥1+
Ability to walk independently with or without assistive devices
Ability to understand and follow instructions for exercise interventions and assessments
Disqualifiers
Receipt of botulinum toxin injection in the affected lower limb within the last 3 months
Severe cognitive impairment preventing participation in assessments
Presence of fixed joint contractures limiting range of motion
Orthopedic or musculoskeletal disorders affecting lower limb function (e.g., fracture, severe osteoarthritis)
Trial design
Design model
Parallel
Treatments tested in this trial
Extracorporeal Shock Wave Therapy (ESWT)
DeviceRadial extracorporeal shock wave therapy will be applied with an energy flux density of 0.10-0.20 mJ/mm², frequency of 5-8 Hz, and 2000-3000 pulses per muscle. Treatment will be administered three times per week for four weeks.
Sham Extracorporeal Shock Wave Therapy
DeviceA sham ESWT procedure will be performed using the same device without energy transmission, mimicking the sound and sensation of treatment.
Treatment groups
85 Participants
are divided into 2 treatment groupsGroup A: ESWT GroupExperimental treatment 1 intervention
Group B: Control Group (Sham ESWT)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Spasticity Assessed by Modified Ashworth Scale (MAS)
Spasticity will be assessed using the Modified Ashworth Scale (MAS), a 6-point ordinal scale ranging from 0 (no increase in muscle tone) to 4 (rigidity). The assessment will be performed on the ankle plantar flexor muscles. A decrease in MAS score indicates improvement in spasticity. Spasticity will be assessed using the Modified Ashworth Scale (MAS), a 6-point ordinal scale ranging from 0 to 4, where: 0 = No increase in muscle tone 1 = Slight increase in muscle tone 1+ = Minimal resistance through less than half of the range 2 = More marked increase in tone 3 = Considerable increase in tone 4 = Rigid in flexion or extension The assessment will be performed on the ankle plantar flexor muscles. Higher scores indicate greater spasticity (worse outcome), while lower scores indicate improvement.
Time frame
Baseline, 4 weeks (post-treatment), and 8 weeks (follow-up)Secondary outcomes
1
Change in Walking Speed Assessed by 10-Meter Walk Test (10MWT)
The 10MWT measures walking speed over a short distance. Participants will be instructed to walk at a comfortable pace, and time will be recorded in seconds. Lower times indicate improved walking performance. Walking speed will be assessed using the 10-Meter Walk Test (10MWT). Participants will walk a 10-meter distance at a comfortable pace. Time will be recorded in seconds. There is no fixed minimum or maximum score; lower time indicates better walking performance.
Time frame
Baseline, 4 weeks, 8 weeks2
Change in Functional Mobility Assessed by Timed Up and Go Test (TUG)
The TUG test evaluates functional mobility. Participants will stand up from a chair, walk 3 meters, turn, walk back, and sit down. The time to complete the task will be recorded in seconds. Lower times indicate better mobility. Functional mobility will be assessed using the Timed Up and Go Test (TUG). Time (seconds) required to stand up, walk 3 meters, turn, return, and sit down will be recorded. There is no fixed minimum or maximum score; lower time indicates better mobility.
Time frame
Baseline, 4 weeks, 8 weeks3
Change in Motor Function Assessed by Fugl-Meyer Assessment - Lower Extremity (FMA-LE)
The FMA-LE assesses motor recovery after stroke, including reflexes, movement coordination, and voluntary control. Scores range from 0 to 34, with higher scores indicating better motor function. Motor function will be assessed using the Fugl-Meyer Assessment for Lower Extremity (FMA-LE). The total score ranges from 0 to 34, with: 0 = Severe impairment 34 = Normal motor function Higher scores indicate better motor function (better outcome).
Time frame
Baseline, 4 weeks, 8 weeks4
Change in Functional Exercise Capacity Assessed by 6-Minute Walk Test (6MWT)
The 6MWT measures the distance a participant can walk in six minutes. It reflects functional exercise capacity and endurance. Greater distances indicate better performance. Functional capacity will be assessed using the 6-Minute Walk Test (6MWT). Total walking distance (meters) in 6 minutes will be recorded. There is no fixed maximum; higher distance indicates better functional capacity. Time Frame: Baseline, 4 weeks, 8 weeks
Time frame
Baseline, 4 weeks, 8 weeksLocations
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Source ClinicalTrials.gov
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