Low Level LASER Therapy in Chronic Stroke Patients With Spastic Planter Flexors.

NCT ID: NCT05425225

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-04
• Study Completion Date: 2022-11-15

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Low level LASER therapy

low level laser therapy in continues wave at a wavelength in the near infrared of 830nm. Power density will be 670 mW/cm2. The treatment time per point will be 30 seconds. Probe head will be placed with light pressure on the calf muscles. Three consecutive treatments will be given in a session, with 5 seconds break in between, giving a total irradiation time of 90 seconds

Group Type: EXPERIMENTAL

Low level LASER therapy

Intervention Type: OTHER

Three consecutive treatments will be given in a session, with 5 seconds break in between, giving a total irradiation time of 90 seconds. Two sessions will be given per week for total of 6 weeks.(20)

Conventional physical therapy

sustained stretching (10 seconds hold), strengthening exercise, balance training and gait training

Group Type: ACTIVE_COMPARATOR

Conventional physical therapy

Intervention Type: OTHER

Hot pack for 15 to 20 minutes followed by 10 repetitions of sustained stretching (10 seconds hold), for 3 days a week for 6 week

Interventions

Low level LASER therapy

Three consecutive treatments will be given in a session, with 5 seconds break in between, giving a total irradiation time of 90 seconds. Two sessions will be given per week for total of 6 weeks.(20)

Intervention Type: OTHER

Conventional physical therapy

Hot pack for 15 to 20 minutes followed by 10 repetitions of sustained stretching (10 seconds hold), for 3 days a week for 6 week

Intervention Type: OTHER

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Binash Afzal, PHD*

Role: PRINCIPAL_INVESTIGATOR

Riphah international university lahore campus

Locations

Shalimar hospital Lahore,PSRD

Lahore, Punjab Province, Pakistan

Countries

Pakistan

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Other Identifiers

REC/Lhr/22/0227 Humza

Identifier Type: -

Identifier Source: org_study_id