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StrokeNCT06357949

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

A study testing High-intensity laser in people with Stroke, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Stroke
What is being tested?
High-intensity laser
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Apr 2024to 25 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

    Ankara

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the detailed 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.

Conditions
Stroke
Being tested
High-intensity laser, Sham laser
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-intensity laserDevice

    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

  • Sham laserDevice

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

Study groups in NCT06357949
Study groupRoleWhat they receive
High-intensity laser therapy groupActive comparatorHigh-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.
Receives: Device: High-intensity laser
Sham groupSham comparatorThe same procedure will be followed, but sham laser will be applied at 0 j/cm2 for 10 minutes.
Receives: Device: Sham laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 10-Meter Walk Test

    Test to measure patients\&amp;amp;amp;#39; functional ambulation skills.

    Measured: Baseline- 3 - 6 weeks(follow up)

Secondary outcomes (6)

  1. 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.

    Measured: Baseline- 3 - 6 weeks(follow up)

  2. Joint Range of Motion (ROM) Measurement

    Passive measurement of ankle joint range of motion (ROM) with a goniometer

    Measured: Baseline- 3 - 6 weeks(follow up)

  3. Ultrasonography

    Sonographic measurement of medial gastrocnemius muscle thickness

    Measured: Baseline- 3 - 6 weeks(follow up)

  4. Timed Up and Go test

    To determine fall risk and measure the progress of balance, sit to stand and walking

    Measured: Baseline- 3 - 6 weeks(follow up)

  5. 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.

    Measured: Baseline- 3 - 6 weeks(follow up)

  6. 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.

    Measured: Baseline- 3 - 6 weeks(follow up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2024
  2. Study start5 Apr 2024
  3. Primary completion1 Sep 2024
  4. Study completion25 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06357949
Sponsor's protocol ID
E2-23-3615
Status last verified
May 2024
First submitted
2 Apr 2024
Last updated
27 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33906450

  • 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.

    PubMed 31827687

  • 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.

    PubMed 27220527

Questions about this trial

What is this clinical trial studying?

A study testing High-intensity laser in people with Stroke, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

10-Meter Walk Test (time frame: Baseline- 3 - 6 weeks(follow up)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06357949, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.

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