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

NCT07364110 | Completed

• 2 other identifiers: 2021/454221518007
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke Gait Rehabilitation

Keywords

stroke; spasticity; equinus deformity; extracorporeal shock wave therapy; high-intensity laser therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).

Secondary Outcomes (5)

• Ankle Range of Motion (ROM)

  Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).

• Fugl-Meyer Lower Extremity Assessment (FM-LE)

  Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).

• Timed Up and Go Test (TUG)

  Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).

• 10-Meter Walk Test

  Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).

• Berg Balance Scale (BBS)

  Baseline, at 3 weeks (end of intervention), and at 12 weeks (follow-up).

Study Arms (3)

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.

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.

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.

Device: High-Intensity Laser Therapy (HILT)

Interventions

Rehabilitation Protocol PROCEDURE

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

Rehabilitation-only group

High-Intensity Laser Therapy (HILT) DEVICE

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

HILT plus rehabilitation group

Extracorporeal Shock Wave Therapy (ESWT) DEVICE

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

ESWT plus rehabilitation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University, Meram Medical School

Konya, Turkey (Türkiye)

Location

Related Publications (23)

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MeSH Terms

Conditions

Stroke; Muscle Spasticity; Equinus Deformity

Interventions

Exercise; Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Talipes; Foot Deformities, Acquired; Foot Deformities; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 23, 2026
• Study Start: May 1, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: January 23, 2026

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

TU (1)