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NCT06357949Completed

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

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

Source: ClinicalTrials.gov · Last updated 27 Sept 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
24 (actual)
First submitted
2 Apr 2024
Start date
5 Apr 2024
Primary completion date
1 Sept 2024
Lead sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Diseases
Stroke
NCT number
NCT06357949

What you commit to

  • Study type: Interventional
  • Participants enrolled: 24
  • From 5 Apr 2024 to the primary completion date, 1 Sept 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Other

  • 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 with severe vision, hearing, and language problems
  • Patients who do not consent to participate in the study

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.