The Effectiveness of High-intensity Laser Therapy on Plantar Flexor Muscle Spasticity in Stroke Patients

Stroke Clinical Trial

Official title:

The Effectiveness of High-intensity Laser Therapy on Plantar Flexor Muscle Spasticity in Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06357949
• Other study ID #: E2-23-3615
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2024
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: Tugba Atan, MD
• Phone: +90 312 2911000
• Email: tubaatan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the effectiveness of high-intensity laser therapy for treating plantar flexor muscle spasticity in subacute and chronic stroke patients, focusing on its impact on spasticity, joint range of motion, pain, muscle thickness, functional ambulation, and quality of life.

Description:

Post-stroke lower limb spasticity disrupts balance and walking, often resulting in decreased walking speed, increased wheelchair use, and the need for caregiver assistance. Various approaches are utilized in spasticity management, including physical therapy, splinting, oral medications, chemical neurolysis, and surgical interventions. Laser therapy is a non-invasive, painless modality used in physiotherapy units, with a low incidence of side effects. Laser therapy has been shown to reduce muscle fatigue and increase peak torque (muscle strength) when applied before exercise. The use of high-intensity laser therapy in physiotherapy protocols has become increasingly common in recent years. Studies suggest that it enhances healing in tendons and ligaments, prevents fibrosis development, increases local blood flow and tissue regeneration, and reduces edema and pain. The aim of this study is to investigate the effectiveness of high-intensity laser therapy for treating plantar flexor muscle spasticity in subacute and chronic stroke patients, focusing on its impact on spasticity, joint range of motion, pain, muscle thickness, functional ambulation, and quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients aged = 18 and = 75 years
• Patients experiencing their first stroke (onset > 3 months)
• Patients with ankle plantar flexor muscle spasticity with a Modified Ashworth Scale (MAS) score = 1 and < 4
• Lower extremity Brunnstrom staging = 3
• Patients describing pain complaints in the affected leg as VAS > 3.
• Patients who can stand independently or with supervision for at least 2 minutes for measurements taken while standing
• Patients who can walk independently or with/without assistive devices for at least 10 meters for measurements taken while walking
• Patients with cognitive abilities sufficient to understand the study instructions (Mini-Mental State Examination score > 23)
• Patients with stable medical and psychological conditions
• Patients willing to participate in the study

Exclusion Criteria:

• Patients with severe cardiovascular or musculoskeletal problems that impair walking (e.g., fixed ankle contracture)
• Patients who have been treated for spasticity with botulinum toxin, phenol, or alcohol injections in the past 6 months
• Patients who have undergone antispastic surgery in the treatment area in the past 6 months
• Patients with recent changes in oral antispastic medication use in the past 6 months
• Patients with acute inflammation or active infection in the treatment area
• Patients with a history of ankle joint contracture, fracture, neoplasm, vascular disease, etc.
• Patients with other neurological (Parkinson's disease, epilepsy, meningitis, cerebellar disease, vertigo, dizziness, polyneuropathy, etc.) or musculoskeletal (severe back pain, knee problems) diseases that could affect balance performance other than stroke
• Patients with severe vision, hearing, and language problems
• Patients who do not consent to participate in the study

Related Conditions & MeSH terms

• Muscle Spasticity
• Stroke

Intervention

Device:
• High-intensity laser
All patients will receive a rehabilitation program consisting of stretching, strengthening, balance, and walking exercises targeting the lower extremities for 45 minutes, 5 days a week, for 6 weeks. Walking training will initially begin on level ground and gradually progress to different levels and surfaces. High-intensity laser will be applied continuously in biostimulation mode 5 days a week, once a day, for a total of 15 sessions over 3 weeks
• Sham laser
The same procedure will be followed, but sham laser will be applied at 0 j/cm2 for 10 minutes.

Locations

Country	Name	City	State
Turkey	Gaziler Physical Medicine and Rehabilitation Education and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Pekyavas NO, Baltaci G. Short-term effects of high-intensity laser therapy, manual therapy, and Kinesio taping in patients with subacromial impingement syndrome. Lasers Med Sci. 2016 Aug;31(6):1133-41. doi: 10.1007/s10103-016-1963-2. Epub 2016 May 25. — View Citation

Tomazoni SS, Machado CDSM, De Marchi T, Casalechi HL, Bjordal JM, de Carvalho PTC, Leal-Junior ECP. Infrared Low-Level Laser Therapy (Photobiomodulation Therapy) before Intense Progressive Running Test of High-Level Soccer Players: Effects on Functional, Muscle Damage, Inflammatory, and Oxidative Stress Markers-A Randomized Controlled Trial. Oxid Med Cell Longev. 2019 Nov 16;2019:6239058. doi: 10.1155/2019/6239058. eCollection 2019. — View Citation

Yoldas Aslan S, Kutlay S, Dusunceli Atman E, Elhan AH, Gok H, Kucukdeveci AA. Does extracorporeal shock wave therapy decrease spasticity of ankle plantar flexor muscles in patients with stroke: A randomized controlled trial. Clin Rehabil. 2021 Oct;35(10):1442-1453. doi: 10.1177/02692155211011320. Epub 2021 Apr 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	10-Meter Walk Test	Test to measure patients' functional ambulation skills.	Baseline- 3 weeks (15 sessions) (follow up)
Secondary	Visual analogue scale for pain (VAS- pain)	Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.	Baseline- 3 weeks (15 sessions) (follow up)
Secondary	Modified Ashworth Scale	Evaluation of plantar flexor muscle spasticity using the Modified Ashworth Scale (MAS). The original Ashworth scale was a 5 point numerical scale that graded spasticity from 0 to 4, with 0 being no resistance and 4 being a limb rigid in flexion or extension.	Baseline- 3 weeks (15 sessions) (follow up)
Secondary	Joint Range of Motion (ROM) Measurement	Passive measurement of ankle joint range of motion (ROM) with a goniometer	Baseline- 3 weeks (15 sessions) (follow up)
Secondary	Ultrasonography	Sonographic measurement of medial gastrocnemius muscle thickness	Baseline- 3 weeks (15 sessions) (follow up)
Secondary	Timed Up and Go test	To determine fall risk and measure the progress of balance, sit to stand and walking	Baseline- 3 weeks (15 sessions) (follow up)
Secondary	Stroke Specific Quality of Life Scale	It is a patient-centered outcome measure intended to provide an assessment of health-related quality of life (HRQOL) specific to patients with stroke. Scores range from 49-245.; Higher scores indicate better functioning.	Baseline- 3 weeks (15 sessions) (follow up)