Stroke Gait RehabilitationspasticityNCT07364110
The Effectiveness of Laser and Extracorporeal Shock Wave Therapy in Resolving Ankle Muscle Spasm in Stroke Patients.
A study testing Rehabilitation Protocol, Extracorporeal Shock Wave Therapy (ESWT) and High-Intensity Laser Therapy (HILT) in people with Stroke Gait Rehabilitation, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Gait Rehabilitation
- What is being tested?
- Rehabilitation Protocol, Extracorporeal Shock Wave Therapy (ESWT) and High-Intensity Laser Therapy (HILT)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-ever stroke;
- At least 3 months elapsed since stroke onset;
- Age ≥18 years;
- Presence of ankle plantar flexor spasticity graded 1-3 on the Modified Ashworth Scale (MAS);
- Ability to ambulate independently or under supervision with or without assistive devices/orthoses;
- Sufficient cognitive capacity to understand and follow test instructions
Who cannot join
- Fixed ankle contracture (peak ankle dorsiflexion <0° with the knee in extension);
- Current use of antispastic medications or a history of botulinum toxin injection within the previous 4 months;
- Any orthopedic, rheumatologic, neurologic, cardiovascular, or visual comorbidity other than stroke that could affect gait;
- Insufficient cognitive function.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University, Meram Medical School
Konya
About this study
Official title: Comparison of High Intensity Laser Therapy (HILT) and Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Plantar Flexor Spasticity in Post-Stroke Patients
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Stroke Gait Rehabilitation
- Being tested
- Rehabilitation Protocol, Extracorporeal Shock Wave Therapy (ESWT), High-Intensity Laser Therapy (HILT)
- Keywords
- stroke, spasticity, equinus deformity, extracorporeal shock wave therapy, high-intensity laser therapy
- Medical subject headings
- Stroke, Muscle Spasticity, Equinus Deformity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation ProtocolProcedure or surgery
Also called Exercise
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
Extracorporeal Shock Wave Therapy (ESWT)Device
Also called 2
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.
High-Intensity Laser Therapy (HILT)Device
Also called 3
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.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation-only group | Placebo comparator | 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. Receives: Procedure: Rehabilitation Protocol |
| ESWT plus rehabilitation group | Experimental | 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. Receives: Device: Extracorporeal Shock Wave Therapy (ESWT) |
| HILT plus rehabilitation group | Experimental | 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. Receives: Device: High-Intensity Laser Therapy (HILT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 May 2021
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Stroke Gait RehabilitationStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SAMİ KÜÇÜKŞEN, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364110
- Sponsor's protocol ID
- 2021/454
- Other IDs
- 221518007
- Acronym
- spasticity
- Status last verified
- May 2021
- First submitted
- 28 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD, all IPD that underlie results in a publication
Publications
Mizuta N, Hasui N, Nakatani T, Takamura Y, Fujii S, Tsutsumi M, Taguchi J, Morioka S. Walking characteristics including mild motor paralysis and slow walking speed in post-stroke patients. Sci Rep. 2020 Jul 16;10(1):11819. doi: 10.1038/s41598-020-68905-3.
PubMed 32678273Bushnell C, Bettger JP, Cockroft KM, Cramer SC, Edelen MO, Hanley D, Katzan IL, Mattke S, Nilsen DM, Piquado T, Skidmore ER, Wing K, Yenokyan G. Chronic Stroke Outcome Measures for Motor Function Intervention Trials: Expert Panel Recommendations. Circ Cardiovasc Qual Outcomes. 2015 Oct;8(6 Suppl 3):S163-9. doi: 10.1161/CIRCOUTCOMES.115.002098.
PubMed 26515205Wade DT. Measurement in neurological rehabilitation. Curr Opin Neurol Neurosurg. 1992 Oct;5(5):682-6.
PubMed 1392142Blum L, Korner-Bitensky N. Usefulness of the Berg Balance Scale in stroke rehabilitation: a systematic review. Phys Ther. 2008 May;88(5):559-66. doi: 10.2522/ptj.20070205. Epub 2008 Feb 21.
PubMed 18292215Bohannon RW. Reference values for the timed up and go test: a descriptive meta-analysis. J Geriatr Phys Ther. 2006;29(2):64-8. doi: 10.1519/00139143-200608000-00004.
PubMed 16914068Amelio E, Manganotti P. Effect of shock wave stimulation on hypertonic plantar flexor muscles in patients with cerebral palsy: a placebo-controlled study. J Rehabil Med. 2010 Apr;42(4):339-43. doi: 10.2340/16501977-0522.
PubMed 20358168Troncati F, Paci M, Myftari T, Lombardi B. Extracorporeal Shock Wave Therapy reduces upper limb spasticity and improves motricity in patients with chronic hemiplegia: a case series. NeuroRehabilitation. 2013;33(3):399-405. doi: 10.3233/NRE-130970.
PubMed 23949081Starosta M, Marek K, Redlicka J, Miller E. Extracorporeal Shockwave Treatment as Additional Therapy in Patients with Post-Stroke Spasticity of Upper Limb-A Narrative Review. J Clin Med. 2024 Mar 30;13(7):2017. doi: 10.3390/jcm13072017.
PubMed 38610782Moon SW, Kim JH, Jung MJ, Son S, Lee JH, Shin H, Lee ES, Yoon CH, Oh MK. The effect of extracorporeal shock wave therapy on lower limb spasticity in subacute stroke patients. Ann Rehabil Med. 2013 Aug;37(4):461-70. doi: 10.5535/arm.2013.37.4.461. Epub 2013 Aug 26.
PubMed 24020026Li TY, Chang CY, Chou YC, Chen LC, Chu HY, Chiang SL, Chang ST, Wu YT. Effect of Radial Shock Wave Therapy on Spasticity of the Upper Limb in Patients With Chronic Stroke: A Prospective, Randomized, Single Blind, Controlled Trial. Medicine (Baltimore). 2016 May;95(18):e3544. doi: 10.1097/MD.0000000000003544.
PubMed 27149465Daliri SS, Forogh B, Emami Razavi SZ, Ahadi T, Madjlesi F, Ansari NN. A single blind, clinical trial to investigate the effects of a single session extracorporeal shock wave therapy on wrist flexor spasticity after stroke. NeuroRehabilitation. 2015;36(1):67-72. doi: 10.3233/NRE-141193.
PubMed 25547767Guo P, Gao F, Zhao T, Sun W, Wang B, Li Z. Positive Effects of Extracorporeal Shock Wave Therapy on Spasticity in Poststroke Patients: A Meta-Analysis. J Stroke Cerebrovasc Dis. 2017 Nov;26(11):2470-2476. doi: 10.1016/j.jstrokecerebrovasdis.2017.08.019. Epub 2017 Sep 13.
PubMed 28918085Dymarek R, Ptaszkowski K, Slupska L, Halski T, Taradaj J, Rosinczuk J. Effects of extracorporeal shock wave on upper and lower limb spasticity in post-stroke patients: A narrative review. Top Stroke Rehabil. 2016 Aug;23(4):293-303. doi: 10.1080/10749357.2016.1141492. Epub 2016 Feb 17.
PubMed 27077981Radinmehr H, Nakhostin Ansari N, Naghdi S, Olyaei G, Tabatabaei A. Effects of one session radial extracorporeal shockwave therapy on post-stroke plantarflexor spasticity: a single-blind clinical trial. Disabil Rehabil. 2017 Mar;39(5):483-490. doi: 10.3109/09638288.2016.1148785. Epub 2016 Mar 13.
PubMed 26971745das Neves MF, Dos Reis MC, de Andrade EA, Lima FP, Nicolau RA, Arisawa EA, Andrade AO, Lima MO. Effects of low-level laser therapy (LLLT 808 nm) on lower limb spastic muscle activity in chronic stroke patients. Lasers Med Sci. 2016 Sep;31(7):1293-300. doi: 10.1007/s10103-016-1968-x. Epub 2016 May 31.
PubMed 27299571
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High Intensity Laser Therapy (HILT) and Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Plantar Flexor Spasticity in Post-Stroke Patients
- ClinicalTrials.gov ID
- NCT07364110
- Acronym / sponsor ID
- spasticity / 2021/454
- Conditions
- Stroke Gait Rehabilitation
- Keywords
- stroke, spasticity, equinus deformity, extracorporeal shock wave therapy, high-intensity laser therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation-only group | Placebo comparator | Procedure: Rehabilitation ProtocolAll 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. |
| ESWT plus rehabilitation group | Experimental | Device: Extracorporeal Shock Wave Therapy (ESWT)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. |
| HILT plus rehabilitation group | Experimental | Device: High-Intensity Laser Therapy (HILT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- First-ever stroke;
- At least 3 months elapsed since stroke onset;
- Age ≥18 years;
- Presence of ankle plantar flexor spasticity graded 1-3 on the Modified Ashworth Scale (MAS);
- Ability to ambulate independently or under supervision with or without assistive devices/orthoses;
Key exclusion criteria (4 listed)
- Fixed ankle contracture (peak ankle dorsiflexion <0° with the knee in extension);
- Current use of antispastic medications or a history of botulinum toxin injection within the previous 4 months;
- Any orthopedic, rheumatologic, neurologic, cardiovascular, or visual comorbidity other than stroke that could affect gait;
- Insufficient cognitive function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation ProtocolAlso: ExerciseAll 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 or surgery | Rehabilitation-only group |
| Extracorporeal Shock Wave Therapy (ESWT)Also: 2Participants 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 | ESWT plus rehabilitation group |
| High-Intensity Laser Therapy (HILT)Also: 3In 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 | HILT plus rehabilitation group |
Primary outcome
Modified Ashworth Scale (MAS)
Time frame: Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).
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.
5 secondary outcomes
Ankle Range of Motion (ROM)
Time frame: Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).
Fugl-Meyer Lower Extremity Assessment (FM-LE)
Time frame: Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).
Timed Up and Go Test (TUG)
Time frame: Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).
10-Meter Walk Test
Time frame: Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).
Berg Balance Scale (BBS)
Time frame: Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Results publication: PubMed 32678273Mizuta N, Hasui N, Nakatani T, Takamura Y, Fujii S, Tsutsumi M, Taguchi J, Morioka S. Walking characteristics including mild motor paralysis and slow walking speed in post-stroke patients. Sci Rep. 2020 Jul 16;10(1):11819. doi: 10.1038/s41598-020-68905-3.
- Results publication: PubMed 26515205Bushnell C, Bettger JP, Cockroft KM, Cramer SC, Edelen MO, Hanley D, Katzan IL, Mattke S, Nilsen DM, Piquado T, Skidmore ER, Wing K, Yenokyan G. Chronic Stroke Outcome Measures for Motor Function Intervention Trials: Expert Panel Recommendations. Circ Cardiovasc Qual Outcomes. 2015 Oct;8(6 Suppl 3):S163-9. doi: 10.1161/CIRCOUTCOMES.115.002098.
- Results publication: PubMed 1392142Wade DT. Measurement in neurological rehabilitation. Curr Opin Neurol Neurosurg. 1992 Oct;5(5):682-6.
- Results publication: PubMed 18292215Blum L, Korner-Bitensky N. Usefulness of the Berg Balance Scale in stroke rehabilitation: a systematic review. Phys Ther. 2008 May;88(5):559-66. doi: 10.2522/ptj.20070205. Epub 2008 Feb 21.
- Results publication: PubMed 16914068Bohannon RW. Reference values for the timed up and go test: a descriptive meta-analysis. J Geriatr Phys Ther. 2006;29(2):64-8. doi: 10.1519/00139143-200608000-00004.
- Results publication: PubMed 20358168Amelio E, Manganotti P. Effect of shock wave stimulation on hypertonic plantar flexor muscles in patients with cerebral palsy: a placebo-controlled study. J Rehabil Med. 2010 Apr;42(4):339-43. doi: 10.2340/16501977-0522.
- Results publication: PubMed 23949081Troncati F, Paci M, Myftari T, Lombardi B. Extracorporeal Shock Wave Therapy reduces upper limb spasticity and improves motricity in patients with chronic hemiplegia: a case series. NeuroRehabilitation. 2013;33(3):399-405. doi: 10.3233/NRE-130970.
- Results publication: PubMed 38610782Starosta M, Marek K, Redlicka J, Miller E. Extracorporeal Shockwave Treatment as Additional Therapy in Patients with Post-Stroke Spasticity of Upper Limb-A Narrative Review. J Clin Med. 2024 Mar 30;13(7):2017. doi: 10.3390/jcm13072017.
- Results publication: PubMed 24020026Moon SW, Kim JH, Jung MJ, Son S, Lee JH, Shin H, Lee ES, Yoon CH, Oh MK. The effect of extracorporeal shock wave therapy on lower limb spasticity in subacute stroke patients. Ann Rehabil Med. 2013 Aug;37(4):461-70. doi: 10.5535/arm.2013.37.4.461. Epub 2013 Aug 26.
- Results publication: PubMed 27149465Li TY, Chang CY, Chou YC, Chen LC, Chu HY, Chiang SL, Chang ST, Wu YT. Effect of Radial Shock Wave Therapy on Spasticity of the Upper Limb in Patients With Chronic Stroke: A Prospective, Randomized, Single Blind, Controlled Trial. Medicine (Baltimore). 2016 May;95(18):e3544. doi: 10.1097/MD.0000000000003544.
- Results publication: PubMed 25547767Daliri SS, Forogh B, Emami Razavi SZ, Ahadi T, Madjlesi F, Ansari NN. A single blind, clinical trial to investigate the effects of a single session extracorporeal shock wave therapy on wrist flexor spasticity after stroke. NeuroRehabilitation. 2015;36(1):67-72. doi: 10.3233/NRE-141193.
- Results publication: PubMed 28918085Guo P, Gao F, Zhao T, Sun W, Wang B, Li Z. Positive Effects of Extracorporeal Shock Wave Therapy on Spasticity in Poststroke Patients: A Meta-Analysis. J Stroke Cerebrovasc Dis. 2017 Nov;26(11):2470-2476. doi: 10.1016/j.jstrokecerebrovasdis.2017.08.019. Epub 2017 Sep 13.
- Individual participant dataSharing planned: Yes. All collected IPD, all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation Protocol, Extracorporeal Shock Wave Therapy (ESWT) and High-Intensity Laser Therapy (HILT) in people with Stroke Gait Rehabilitation, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (MAS) (time frame: Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07364110, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.