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

NCT06357949 | Completed

• 1 other identifier: E2-23-3615
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 10-Meter Walk Test

  Test to measure patients\' functional ambulation skills.

  Baseline- 3 - 6 weeks(follow up)

Secondary Outcomes (6)

• Modified Ashworth Scale

  Baseline- 3 - 6 weeks(follow up)

• Joint Range of Motion (ROM) Measurement

  Baseline- 3 - 6 weeks(follow up)

• Ultrasonography

  Baseline- 3 - 6 weeks(follow up)

• Timed Up and Go test

  Baseline- 3 - 6 weeks(follow up)

• Stroke Specific Quality of Life Scale

  Baseline- 3 - 6 weeks(follow up)

Study Arms (2)

High-intensity laser therapy group

ACTIVE COMPARATOR

High-intensity laser will be applied continuously to the gastrocnemius muscle for a total of 10 minutes with an energy density of 100 j/cm2, totaling 2500 j.

Device: High-intensity laser

Sham group

SHAM COMPARATOR

The same procedure will be followed, but sham laser will be applied at 0 j/cm2 for 10 minutes.

Device: Sham laser

Interventions

High-intensity laser DEVICE

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 3 days a week, once a day, for a total of 9 sessions over 3 weeks

High-intensity laser therapy group

Sham laser DEVICE

The same procedure will be followed, but sham laser will be applied at 0 j/cm2 for 10 minutes.

Sham group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 33906450 BACKGROUND

• 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.

  PMID: 31827687 BACKGROUND

• 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.

  PMID: 27220527 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tugba Atan

  Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

  PRINCIPAL INVESTIGATOR

• Yunus Emre Bildik

  Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 10, 2024
• Study Start: April 5, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 25, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)