The goal of this clinical trial is to learn if radial Extracorporeal Shock Wave Therapy (rESWT) is effective in reducing ankle plantar flexor spasticity and improving walking functions in stroke patients who have already received Botulinum Toxin type A (BoNT-A) injections. The main questions it aims to answer are: * Does adding rESWT to standard physical therapy significantly lower muscle spasticity in patients who have received BoNT-A, compared to receiving physical therapy alone after the injection? * Does combining rESWT with BoNT-A injection improve functional walking parameters (such as gait speed, cadence, and step length) and daily life independence more than the BoNT-A and physical therapy combination alone? * Can rESWT induce additional structural and flexibility improvements in the BoNT-A injected gastrocnemius muscle, as measured objectively by ultrasound imaging and strain elastography? Researchers will compare a group of participants receiving both rESWT and conventional physical therapy (Group 1) to a comparison group receiving only conventional physical therapy (Group 2) to see if rESWT provides additional clinical benefits. All participants in both groups will have already undergone routine BoNT-A injections one week prior to starting the study treatments. Participants will: * Undergo a 3-week conventional physical therapy and rehabilitation program, consisting of 2 to 3 hours of therapy per day, 5 days a week. * Receive 3 weekly sessions of rESWT (2000 pulses per session applied to the calf muscles) if they are randomized into the rESWT group. * Attend clinical evaluation visits and objective assessment sessions-including high-tech computerized gait analysis and specialized musculoskeletal ultrasound imaging-before the treatment, at the end of the 3rd week, and at a 12-week follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
Applied 1 week after the routine Botulinum Toxin Type A (BoNT-A) injection. Patients receive 3 sessions (once a week for 3 weeks) of rESWT to the medial and lateral heads of the gastrocnemius muscle in the prone position with knee in full extension and ankle in neutral. Dose parameters: 2000 pulses per session, 5 Hz frequency, and 60 mJ (1 bar) energy level using a 15 mm transmitter head (calculated energy flux density: 0.340 mJ/mm²).
A 3-week comprehensive rehabilitation program performed 2-3 hours per day, 5 days a week. The program includes passive/active range of motion exercises, stretching exercises, progressive resistive exercises, positioning, postural control, weight-shifting, balance training, gait training, occupational therapy, and speech therapy based on individual patient needs.
Pamukkale University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Denizli, Denizli, Turkey (Türkiye)
Change from Baseline in Muscle Spasticity Grade using the Modified Ashworth Scale (MAS)
The MAS is a clinical scale used to assess resistance to passive movement in a joint affected by spasticity. Scores range from 0 to 4 (with an additional 1+ score), where 0 indicates no increase in muscle tone and 4 indicates the affected part is rigid in flexion or extension. Higher scores represent greater muscle spasticity.
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Passive Ankle Dorsiflexion Range of Motion (ROM)
Measured in degrees using a standard universal goniometer. The measurement will be taken with the patient in the supine position and the knee fully extended to better demonstrate the gastrocnemius muscle restriction. Higher degrees indicate better range of motion.
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Activities of Daily Living Using the Modified Barthel Index (MBI)
The MBI is used to assess the patient's level of independence in 10 activities of daily living. Total scores range from 0 to 100, where higher scores reflect greater independence.
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Lower Extremity Motor Function Using the Fugl-Meyer Assessment Lower Extremity (FMA-LE)
The FMA-LE is an index designed to assess sensorimotor impairment post-stroke. The lower extremity subscale consists of items scoring reflexes, voluntary movements, and coordination, with total scores ranging from 0 to 34. Higher scores indicate better motor function.
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Muscle Fibrotic Alterations Using the Modified Heckmatt Scale
visual ultrasound grading scale used to evaluate echogenic changes and fibrotic levels in the spastic muscle tissue. Scores range from Grade 1 (normal muscle echogenicity) to Grade 4 (very strong muscle echogenicity with complete loss of bone echo). Higher grades indicate increased fibrotic changes and muscle echo intensity.
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Muscle Stiffness Using Sonoelastography Strain Index (SI)
Musculoskeletal strain ultrasound elastography will be used to analyze tissue deformation and calculate the elasticity index. Scores range from 0.0 to 6.0, where higher index values represent greater muscle tissue stiffness.
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Muscle Stiffness Using Sonoelastography Strain Ratio (SR)
The strain ratio is calculated automatically by the ultrasound software as the ratio of tissue deformation between the target spastic muscle area and a reference subcutaneous fat area (muscle/reference area). A higher strain ratio represents greater muscle tissue stiffness and loss of elasticity.
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Walking Velocity Using Rehawalk Computerized Analysis
Objective spatiotemporal variable captured via the Rehawalk Zebris FDM-T pressure-sensor matrix. This outcome will specifically measure overall walking velocity during steady-state treadmill walking. The data will be evaluated and reported in kilometers per hour (km/h). Higher values indicate an improvement in walking speed.
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Cadence Using Rehawalk Computerized Analysis
Objective spatiotemporal variable evaluating the step frequency during treadmill walking. This outcome will record the total number of steps taken per minute. The data will be evaluated and reported in steps per minute (steps/min). Higher cadence values reflect a closer-to-normal stepping frequency.
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Step Width Using Rehawalk Computerized Analysis
Objective spatial gait parameter measured via the Rehawalk Zebris FDM-T pressure-sensor matrix. This outcome evaluates the lateral distance between both feet during steady-state treadmill walking. The data will be recorded and reported in centimeters (cm).
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Single-Support Phase Duration Using Rehawalk Computerized Analysis
Objective temporal gait parameter reflecting the duration of the gait cycle during which only one foot is in contact with the treadmill surface. Measurements will be recorded for both the affected and unaffected lower limbs. The data will be reported in seconds (sec) or as a percentage (%) of the total gait cycle.
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Double-Support Phase Duration Using Rehawalk Computerized Analysis
Objective temporal gait parameter reflecting the duration of the gait cycle during which both feet are simultaneously in contact with the treadmill surface. This parameter is crucial for assessing dynamic stability post-stroke. The data will be reported in seconds (sec) or as a percentage (%) of the total gait cycle.
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Stride Length Using Rehawalk Computerized Analysis
Objective spatial gait parameter measuring the linear distance between two successive heel strikes of the same foot (double step length). This will be evaluated to track improvements in step efficiency and limb advancement. The data will be recorded and reported in centimeters (cm).
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
Change from Baseline in Temporal Gait Symmetry Index (TGSI) Using Rehawalk Computerized Analysis
An index calculated from the temporal parameters captured by the sensor matrix to evaluate hemiparetic gait asymmetry. The specific mathematical formula used is: (Single support duration of the patient's unaffected side / Single support duration of the affected side). A value closer to 1.0 represents a more symmetrical, balanced, and normal gait pattern. (Unit of measure: Score/Ratio).
Time frame: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
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