An interventional study of Rehabilitation Protocol and Extracorporeal Shock Wave Therapy (ESWT) in Stroke Gait Rehabilitation, sponsored by Necmettin Erbakan University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Necmettin Erbakan University · Not applicable, Interventional, and Treatment
Stroke is one of the leading causes of long-term disability worldwide. Spasticity (muscle spasm) is a common and disabling consequence of stroke. Lower extremity spasticity significantly compromises postural control, balance, and gait performance. Patients with spasticity demonstrate greater difficulty in standing and walking compared with non-spastic stroke survivors.
Management of spasticity includes physical therapy modalities, exercise programs, orthoses, and pharmacological agents. In recent years, novel noninvasive treatment modalities including extracorporeal shock wave therapy (ESWT), and low- and high-intensity laser therapy (HILT) have been investigated for spasticity management however, robust evidence remains limited.
ESWT is a treatment method applied by focusing high-pressure sound waves produced outside the body on the desired area of the body using a steel-tipped applicator. Patients can resume their daily activities immediately after a treatment session lasting between 5-20 minutes. Scientific researches have demonstrated that ESWT is a safe and effective modality for reducing upper and lower extremity spasticity after stroke.
HILT is a a non-invasive, advanced therapeutic approach that utilizes high-intensity laser technology to promote healing and alleviate pain. It has been widely used in musculoskeletal disorders and generally well tolerated without significant adverse effects. Previous studies suggest that laser application to spastic muscles after stroke may reduce spasticity and pain.
The present study aimed to investigate and compare the effects of ESWT and HILT applied to the calf muscles on spasticity and functional gait parameters only with clinical examination methods in patients with stroke.
Stroke is defined as an acute episode of focal dysfunction of the brain, retina, or spinal cord lasting longer than 24 hours, or of any duration if imaging or autopsy demonstrates focal infarction or hemorrhage relevant to the symptoms.
Stroke is one of the leading causes of mortality, long-term disability, and socioeconomic burden worldwide. Although approximately 88% of patients survive a stroke, a substantial proportion experience persistent impairments that limit independent living and participation in daily activities.
Spasticity is a common and disabling consequence of stroke and is defined as a motor disorder characterized by a velocity-dependent increase in tonic stretch reflexes resulting from abnormal intra-spinal processing of primary afferent input. It arises from impaired reflex modulation and leads to secondary changes in muscle tissue such as increased stiffness, fibrosis, and muscle atrophy. Post-stroke spasticity affects approximately 30% of patients and may develop at variable time points following stroke onset.
Lower extremity spasticity significantly compromises postural control, balance, and gait performance. Patients with spasticity demonstrate greater difficulty in standing and walking compared with non-spastic stroke survivors. Among lower limb muscles, the gastrocnemius medialis is most frequently affected, and its involvement is strongly associated with impaired gait mechanics and reduced walking efficiency.
Management of spasticity includes physical therapy modalities, comprehensive neurorehabilitation programs, orthoses, pharmacological agents, and surgical interventions. Stretching exercises constitute the cornerstone of rehabilitation, aiming to improve the viscoelastic properties of the muscle-tendon unit and prevent fixed contractures.
Systemic pharmacological treatment is generally reserved for generalized spasticity, whereas focal spasticity is preferably managed with local treatments such as phenol, alcohol, or botulinum toxin type A injections.
In recent years, novel noninvasive treatment modalities including extracorporeal shock wave therapy, low- and high-intensity laser therapy, dry needling, and therapeutic ultrasound have been investigated for spasticity management; however, robust evidence remains limited.
Laser therapy is a noninvasive modality that induces biological effects at the cellular and tissue levels depending on wavelength, energy density, and power. Both low-intensity and high-intensity laser therapies have been widely used in musculoskeletal disorders and are generally well tolerated with a low incidence of adverse effects. Previous studies suggest that laser application to spastic muscles after stroke may reduce spasticity and pain while improving joint range of motion and muscle endurance.
Extracorporeal shock wave therapy consists of short-duration, high-pressure acoustic pulses transmitted to biological tissues. Radial ESWT delivers lower energy and peak pressure compared with focused ESWT, with therapeutic penetration up to approximately 3.5 cm. Proposed mechanisms of action include nitric oxide release, neuromodulation, axonal regeneration, enhancement of vascular endothelial growth factor activity, and increased expression of neurotrophins, leading to improved neural and muscular function.
Systematic reviews and meta-analyses have demonstrated that ESWT is a safe and effective modality for reducing upper and lower extremity spasticity after stroke, with significant reductions in MAS scores reported immediately after treatment and at short-term follow-up.
Despite improvements in muscle tone, the impact of spasticity treatments on functional gait outcomes remains insufficiently established. Therefore, the development of novel treatment strategies is necessary to optimize functional recovery in stroke survivors.
The present study aimed to investigate and compare the effects of ESWT and HILT applied to the gastrocnemius muscle on plantar flexor spasticity and functional gait parameters in patients with stroke.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 39 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
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Exclusion Criteria:
All participants received a standardized rehabilitation program consisting of 1-hour sessions, 5 days per week, for 3 consecutive weeks. The program included: * Range of motion and stretching exercises targeting the hamstrings, rectus femoris, and ankle plantar flexors; * Strengthening exercises for hip flexors, hip extensors, knee extensors, hamstrings, ankle plantar flexors, and trunk muscles; * Gait training, postural exercises, balance training, transfer training, and endurance exercises, all performed under the supervision of a physiotherapist.
Procedure: Rehabilitation Protocol
Participants in the ESWT group received ESWT once weekly for 3 consecutive weeks (total of 3 sessions), in addition to the rehabilitation program. ESWT was applied to the gastrocnemius muscle belly in the prone position using a Starz Medical Masterpuls MP100 device, with the following parameters: frequency 5 Hz, energy flux density 0.340 mJ/mm², 2000 pulses, and a 15-mm applicator.
Device: Extracorporeal Shock Wave Therapy (ESWT)
In addition to the rehabilitation program, participants in the HILT group received HILT three times per week for 3 consecutive weeks (total of 9 sessions). Each session lasted 4 minutes. HILT was applied to the gastrocnemius muscle belly in the prone position using longitudinal movements, with an energy density of 50 J/cm² and output power of 5 W in biostimulatory mode, using a BTL-6000 High-Intensity Laser device.
Device: High-Intensity Laser Therapy (HILT)
All participants received a standardized rehabilitation program consisting of 1-hour sessions, 5 days per week, for 3 consecutive weeks. The program included: * Range of motion and stretching exercises targeting the hamstrings, rectus femoris, and ankle plantar flexors; * Strengthening exercises for hip flexors, hip extensors, knee extensors, hamstrings, ankle plantar flexors, and trunk muscles; * Gait training, postural exercises, balance training, transfer training, and endurance exercises, all performed under the supervision of a physiotherapist
Also known as: Exercise
Participants in the ESWT group received ESWT once weekly for 3 consecutive weeks (total of 3 sessions), in addition to the rehabilitation program. ESWT was applied to the gastrocnemius muscle belly in the prone position using a Starz Medical Masterpuls MP100 device, with the following parameters: frequency 5 Hz, energy flux density 0.340 mJ/mm², 2000 pulses, and a 15-mm applicator.
Also known as: 2
In addition to the rehabilitation program, participants in the HILT group received HILT three times per week for 3 consecutive weeks (total of 9 sessions). Each session lasted 4 minutes. HILT was applied to the gastrocnemius muscle belly in the prone position using longitudinal movements, with an energy density of 50 J/cm² and output power of 5 W in biostimulatory mode, using a BTL-6000 High-Intensity Laser device.
Also known as: 3
Modified Ashworth Scale (MAS)
Plantar flexor spasticity was assessed using the Modified Ashworth Scale (MAS), a widely used clinical instrument for evaluating resistance to passive movement. The MAS is employed to quantify increases in muscle tone and grades spasticity on an ordinal scale ranging from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates rigidity of the affected limb in flexion or extension.
Time frame: Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).
Ankle Range of Motion (ROM)
Ankle dorsiflexion range of motion was measured using a standard goniometer, with the hip and knee positioned at 90° of flexion. The normal range of ankle dorsiflexion is considered to be approximately 20 degrees.
Time frame: Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).
Fugl-Meyer Lower Extremity Assessment (FM-LE)
The Fugl-Meyer Lower Extremity Assessment (FM-LE) is a standardized and validated tool used to quantify motor recovery following stroke. It evaluates motor impairments of the lower extremity as well as postural control. The FM-LE consists of 14 items assessing movements of the hip, knee, and ankle. Each item is scored on a 3-point ordinal scale ranging from 0 (no active movement) to 2 (normal movement), with a maximum possible score of 28 points (range: 0-28). Higher scores indicate better motor function and greater recovery.
Time frame: Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).
Timed Up and Go Test (TUG)
The Timed Up and Go Test (TUG) is a functional mobility assessment used to evaluate balance, walking ability, and fall risk in older adults and individuals with neurological disorders. The test measures the time required for an individual to stand up from a chair, walk three meters, turn around, walk back, and sit down. Longer completion times indicate poorer functional performance. A TUG time of 20 seconds or more is associated with reduced physical performance and an increased risk of falls.
Time frame: Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).
10-Meter Walk Test
The 10-Meter Walk Test is a performance-based measure used to assess gait speed, expressed in meters per second, over a short distance. It is commonly utilized to evaluate functional mobility, gait efficiency, and balance. In individuals with stroke, walking speeds below 0.7 m/s are associated with an increased risk of falls, hospitalization, and dependency in daily activities.
Time frame: Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).
Berg Balance Scale (BBS)
The Berg Balance Scale (BBS) is a clinical assessment tool used to objectively evaluate static and dynamic balance through a series of functional tasks, including sitting to standing, standing under varying sensory and base-of-support conditions, reaching, turning, and stepping. The scale consists of 14 items, each scored on a 5-point scale from 0 to 4, yielding a maximum total score of 56 points. Higher scores indicate better balance performance, whereas lower scores are associated with an increased risk of falls. A score of 49 or below is considered indicative of fall risk in individuals with stroke.
Time frame: Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).
Plan to share: Yes — All collected IPD, all IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Starting 6 months after publication- ending 2 years after the publication of results
Access criteria: Journal editors or reviewers may request this information from the corresponding author's email address if they deem it necessary.
Ran from May 2021 to primary completion in Mar 2022, 10 months.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 10 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
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