The Effectiveness of Laser and Extracorporeal Shock Wave Therapy in Resolving Ankle Muscle Spasm in Stroke Patients. (spasticity)

Necmettin Erbakan University

Status: Completed

Conditions: Stroke Gait Rehabilitation

Treatments: Device: High-Intensity Laser Therapy (HILT); Device: Extracorporeal Shock Wave Therapy (ESWT); Procedure: Rehabilitation Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT07364110

221518007 (Other Grant/Funding Number)

2021/454

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. First-ever stroke;
2. At least 3 months elapsed since stroke onset;
3. Age ≥18 years;
4. Presence of ankle plantar flexor spasticity graded 1-3 on the Modified Ashworth Scale (MAS);
5. Ability to ambulate independently or under supervision with or without assistive devices/orthoses;
6. Sufficient cognitive capacity to understand and follow test instructions

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 3 patient groups, including a placebo group

Rehabilitation-only group

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Rehabilitation Protocol

ESWT plus rehabilitation group

Experimental group

Description:

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.

Treatment:

Device: Extracorporeal Shock Wave Therapy (ESWT)

HILT plus rehabilitation group

Experimental group

Description:

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.

Treatment:

Device: High-Intensity Laser Therapy (HILT)