Stroke, Post-Stroke Spasticity, Lower Limb Spasticity
Conditions
Keywords
Extracorporeal Shock Wave, ESWT Stroke Rehabilitation, Mobility Fugl-Meyer, Quality of Life, Spasticity
Brief summary
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.
Detailed description
Stroke is one of the leading causes of long-term disability worldwide and is frequently associated with motor impairments, including spasticity. Post-stroke spasticity is characterized by increased muscle tone, exaggerated tendon reflexes, and resistance to passive movement, which can significantly impair functional mobility, gait performance, and independence in daily activities. Lower limb spasticity, particularly involving the plantar flexor muscles, plays a critical role in limiting walking ability and increasing the risk of falls. Conventional treatment approaches for spasticity include physiotherapy interventions, oral medications, and botulinum toxin injections. However, these methods may have limited effectiveness, potential side effects, or high costs. Therefore, there is a need for alternative, non-invasive, and effective treatment options. Extracorporeal shock wave therapy (ESWT) has recently emerged as a promising non-invasive modality for the management of spasticity. ESWT is thought to reduce muscle tone by altering muscle viscoelastic properties, modulating neuromuscular transmission, and improving local blood circulation. Previous studies have suggested beneficial effects of ESWT on spasticity; however, evidence regarding its impact on functional outcomes such as gait performance and quality of life remains limited and inconsistent. This study is designed as a prospective, randomized, single-blind, sham-controlled clinical trial conducted at a tertiary rehabilitation center. A total of 85 participants with chronic stroke (≥3 months) and lower extremity spasticity (Modified Ashworth Scale ≥1+) will be recruited. Participants will be randomly assigned to either the ESWT group or the control group using a block randomization method. The intervention group will receive radial ESWT applied to the gastrocnemius and soleus muscles in addition to a standard physiotherapy program. The ESWT parameters will include an energy flux density of 0.10-0.20 mJ/mm², frequency of 5-8 Hz, and 2000-3000 pulses per muscle, administered three times per week for four weeks. The control group will receive sham ESWT with identical procedures but without therapeutic energy delivery. Both groups will undergo a standardized rehabilitation program consisting of stretching, strengthening, balance training, and gait training. Outcome measures will be assessed at baseline, post-treatment (4 weeks), and follow-up (8 weeks). The primary outcome is spasticity measured by the Modified Ashworth Scale (MAS). Secondary outcomes include walking performance assessed by the 10-Meter Walk Test (10MWT) and Timed Up and Go (TUG) test, motor function assessed by the Fugl-Meyer Assessment for the lower extremity (FMA-LE), and health-related quality of life assessed by the Stroke-Specific Quality of Life (SS-QOL) scale. The findings of this study are expected to provide high-quality evidence regarding the clinical effectiveness of ESWT in reducing spasticity and improving functional outcomes in stroke survivors. This may contribute to the development of more effective and evidence-based rehabilitation strategies.
Interventions
Radial 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.
A sham ESWT procedure will be performed using the same device without energy transmission, mimicking the sound and sensation of treatment.
Sponsors
Istanbul Medipol University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
This study is designed as a single-blind trial. Participants will be blinded to group allocation through the use of sham ESWT in the control group. Outcome assessors will also be blinded to the intervention groups. The therapist delivering the treatment will not be blinded.
Intervention model description
Participants will be randomly assigned to one of two parallel groups: an intervention group receiving extracorporeal shock wave therapy (ESWT) in addition to standard physiotherapy, and a control group receiving sham ESWT along with the same physiotherapy program. Outcomes will be compared between groups over time.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Provided written informed consent
Exclusion criteria
* 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) * Uncontrolled cardiovascular, respiratory, or systemic disease contraindicating exercise * Participation in another interventional clinical trial * Any condition judged by the investigator to interfere with participation or safety
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Spasticity Assessed by Modified Ashworth Scale (MAS) | Baseline, 4 weeks (post-treatment), and 8 weeks (follow-up) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Walking Speed Assessed by 10-Meter Walk Test (10MWT) | Baseline, 4 weeks, 8 weeks | 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. |
| Change in Functional Mobility Assessed by Timed Up and Go Test (TUG) | Baseline, 4 weeks, 8 weeks | 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. |
| Change in Motor Function Assessed by Fugl-Meyer Assessment - Lower Extremity (FMA-LE) | Baseline, 4 weeks, 8 weeks | 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). |
| Change in Functional Exercise Capacity Assessed by 6-Minute Walk Test (6MWT) | Baseline, 4 weeks, 8 weeks | 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 |
| Change in Health-Related Quality of Life Assessed by Stroke-Specific Quality of Life Scale (SS-QOL) | Baseline, 4 weeks, 8 weeks | The SS-QOL is a stroke-specific questionnaire assessing multiple domains including mobility, self-care, mood, and social participation. Higher scores indicate better quality of life. Quality of life will be assessed using the Stroke-Specific Quality of Life Scale (SS-QOL). The scale ranges from approximately 49 to 245, depending on scoring method. Higher scores indicate better quality of life (better outcome). |
Contacts
CONTACTMehmet Salih SALİH TAN, Doctoral
Outcome results
None listed