Clinical trial NCT05425225: Low Level LASER Therapy in Chronic Stroke Patients With Spastic Planter Flexors.
Official title: Effects of Low Level LASER Therapy on Spasticity and Gait Parameters in Chronic Stroke Patients With Spastic Planter Flexors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Muscle Spasticity
Gait Analysis
Low-Level Laser Therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 18
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low-intensity LASER therapy on the spastic muscle, would result in improving muscle performance and improving the functional capacity of individuals under the exercises imposed by physical therapy. In this study the effect of low level LASER therapy will be evaluated on spastic planter flexor of chronic stroke patients and on their gait parameters. After this study post stroke planter flexor spasticity will be cured by low level LASER which will help to improve their gait mechanics.

Detailed description: Cerebrovascular accident (CVA) is defined as interruption of brain blood supply, which may affect basic motor functions, including spasticity. This post-stroke spasticity causes pain, muscle force reduction, changes in gait parameters and decreases the time to onset of muscle fatigue. These factors may lead to difficulty in maintaining an effective and comfortable speed when walking due to high-energy demand and the deficit of aerobic endurance, compromising the functional mobility in chronic stroke patients. Several therapeutic resources have been employed to treat post-stroke spasticity and functional recovery, one of the latest therapy which is used for muscular rehabilitation is Low-level LASER therapy (LLLT). The effect of LLLT on specific spastic muscle groups has not yet been studied in detail in those of chronic stroke patients.

The aim of this study is to evaluate the effect of the application of LLLT on spastic plantar flexor muscles and on gait parameters in patients with chronic stroke.Lower limb spasticity can result in the sustained over activity of the triceps surae muscle, which then leads to the equinus of the foot. The equinus foot can cause ankle instability during the loading response phase and poor toe clearance during the swing phase of gait.

Spastic drop foot is around 20% in stroke survivors. Spastic foot drop occurs primarily due to a combination of weakness of ankle dorsiflexors and spasticity of plantar flexors, associated with weakness of ankle evertors and/or spasticity of invertors. Spastic drop foot prevents heel strike, impairs walking, limits the activities of daily living, and contributes to injuries) LLLT is widely used in the clinic and encompasses a range of non-invasive therapeutic aspects. LLLT is commonly used clinically as a red light near-infrared wave with a length of 600 to 1000 nm and 5 to 500 mW.5 On the contrary, lasers used in surgery have a wavelength of 300 nm.6 Low-power lasers are capable of penetrating deep into the skin so that the surface of the skin does not burn and damage Low-power or cold lasers have been enhanced to the point of being able to produce analgesia and healing acceleration for many clinical conditions.A wide range of LLLT and related techniques have been used. Therefore, the results of treatment with low-power lasers may contradict each other.

The randomized controlled trial will recruit patients according to consecutive sampling into the control group and intervention group. The Control group will receive conventional treatment of spasticity, hot pack for 15 to 20 minutes followed by 10 repetitions of sustained stretching (10 seconds hold), strengthening exercise, balance training and gait training for eight weeks and two sessions each week and the interventional group will receive Low-level LASER therapy for eight weeks and two session per week in addition to the conventional therapy. For this study, we will use The Modified Ashworth Scale (for spasticity), goniometer (for muscle angle), and Wisconsin gait scale (for gait parameters) as tools of assessment. Data will be analyzed on SPSS software version 25.

Eligibility criteria: Inclusion Criteria:

* Age between 45-70 years.
* Both male and female patients with chronic stroke.
* Patients diagnosed with stroke for at least 1 year.
* Medical referral for physiotherapy.
* Cognitive preserved, being able to respond to verbal stimuli.
* Modified Ashworth scale, with a maximum of 2 degree of spasticity in planter flexor.

Exclusion Criteria:

* Patients with other neurologic conditions, orthopedic problems, and uncontrolled metabolic diseases eliminate confounding factors affecting balance performance.

  * Unable to understand and answer a simple verbal command.
  * Severe hearing and visual loss.
  * Patients who are already performing structured physical activities such as muscle strengthening exercises, Pilates, yoga or high intensity aerobic exercises.
  * Patients with Hypoesthesia and/or Hyperesthesia of the side to be studied.
  * The presence of active infection and rashes at the site of application of the laser Application.
  * Uncontrolled arterial hypertension.
  * Presence of neoplastic lesion at the site of application

Primary outcomes:
measure: Modified Ashwarth scale
timeFrame: 6th week
measure: Wisconsin gait scale
timeFrame: 6th week
measure: Goniometer
timeFrame: 6th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Shalimar hospital Lahore,PSRD
state: Punjab
Study officials:
affiliation: Riphah international university lahore campus
name: Binash Afzal, PHD*
role: PRINCIPAL_INVESTIGATOR
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