Stroke
Conditions
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.
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.
Interventions
DEVICEHigh-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 3 days a week, once a day, for a total of 9 sessions over 3 weeks
DEVICESham laser
The same procedure will be followed, but sham laser will be applied at 0 j/cm2 for 10 minutes.
Sponsors
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 10-Meter Walk Test | Baseline- 3 - 6 weeks(follow up) | Test to measure patients&amp;#39; functional ambulation skills. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Joint Range of Motion (ROM) Measurement | Baseline- 3 - 6 weeks(follow up) | Passive measurement of ankle joint range of motion (ROM) with a goniometer |
| Ultrasonography | Baseline- 3 - 6 weeks(follow up) | Sonographic measurement of medial gastrocnemius muscle thickness |
| Modified Ashworth Scale | Baseline- 3 - 6 weeks(follow up) | 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. |
| Stroke Specific Quality of Life Scale | Baseline- 3 - 6 weeks(follow up) | 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. |
| Visual analogue scale for pain (VAS- pain) | Baseline- 3 - 6 weeks(follow up) | 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. |
| Timed Up and Go test | Baseline- 3 - 6 weeks(follow up) | To determine fall risk and measure the progress of balance, sit to stand and walking |
Countries
Turkey (Türkiye)
Outcome results
None listed