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

Stroke Clinical Trial

Official title:

Effects of Low Level LASER Therapy on Spasticity and Gait Parameters in Chronic Stroke Patients With Spastic Planter Flexors.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05425225
• Other study ID #: REC/Lhr/22/0227 Humza
• Status: Completed
• Phase: N/A
• Start date: March 4, 2022
• Est. completion date: November 15, 2022

Study information

• Verified date: January 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• 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)
• 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

Locations

Country	Name	City	State
Pakistan	Shalimar hospital Lahore,PSRD	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (12)

Boonswang NA, Chicchi M, Lukachek A, Curtiss D. A new treatment protocol using photobiomodulation and muscle/bone/joint recovery techniques having a dramatic effect on a stroke patient's recovery: a new weapon for clinicians. BMJ Case Rep. 2012 Sep 11;2012:bcr0820114689. doi: 10.1136/bcr.08.2011.4689. — View Citation

Chung H, Dai T, Sharma SK, Huang YY, Carroll JD, Hamblin MR. The nuts and bolts of low-level laser (light) therapy. Ann Biomed Eng. 2012 Feb;40(2):516-33. doi: 10.1007/s10439-011-0454-7. Epub 2011 Nov 2. — View Citation

da Silva BP, Souza GADS, Filho AADN, Pinto AP, Guimaraes CL, Pereira APC, Neves MFD, Martins PSLL, Lima FPS, Lopes-Martins RAB, Lima MO. Analysis of the effects of low-level laser therapy on muscle fatigue of the biceps brachii muscle of healthy individuals and spastic individuals: Study protocol for a single-center, randomized, double-blind, and controlled clinical trial. Medicine (Baltimore). 2019 Sep;98(39):e17166. doi: 10.1097/MD.0000000000017166. — View Citation

das Neves MF, Aleixo DC, Mendes IS, Lima FPS, Nicolau RA, Arisawa EAL, Lopes-Martins RAB, Lima MO. Long-term analyses of spastic muscle behavior in chronic poststroke patients after near-infrared low-level laser therapy (808 nm): a double-blinded placebo-controlled clinical trial. Lasers Med Sci. 2020 Sep;35(7):1459-1467. doi: 10.1007/s10103-019-02920-3. Epub 2019 Dec 10. — View Citation

das Neves MF, Dos Reis MC, de Andrade EA, Lima FP, Nicolau RA, Arisawa EA, Andrade AO, Lima MO. Effects of low-level laser therapy (LLLT 808 nm) on lower limb spastic muscle activity in chronic stroke patients. Lasers Med Sci. 2016 Sep;31(7):1293-300. doi: 10.1007/s10103-016-1968-x. Epub 2016 May 31. — View Citation

dos Reis MC, de Andrade EA, Borges AC, de Souza DQ, Lima FP, Nicolau RA, Andrade AO, Lima MO. Immediate effects of low-intensity laser (808 nm) on fatigue and strength of spastic muscle. Lasers Med Sci. 2015 Apr;30(3):1089-96. doi: 10.1007/s10103-014-1702-5. Epub 2015 Jan 23. — View Citation

Huang YY, Gupta A, Vecchio D, de Arce VJ, Huang SF, Xuan W, Hamblin MR. Transcranial low level laser (light) therapy for traumatic brain injury. J Biophotonics. 2012 Nov;5(11-12):827-37. doi: 10.1002/jbio.201200077. Epub 2012 Jul 17. — View Citation

Jan F, Naeem A, Malik AN, Amjad I, Malik T. Comparison of low level laser therapy and interferential current on post stroke shoulder pain. J Pak Med Assoc. 2017 May;67(5):788-789. — View Citation

Kholoosy L, Elyaspour D, Akhgari MR, Razzaghi Z, Khodamardi Z, Bayat M. Evaluation of the Therapeutic Effect of Low Level Laser in Controlling Low Back Pain: A Randomized Controlled Trial. J Lasers Med Sci. 2020 Spring;11(2):120-125. doi: 10.34172/jlms.2020.21. Epub 2020 Mar 15. — View Citation

Mansouri V, Arjmand B, Rezaei Tavirani M, Razzaghi M, Rostami-Nejad M, Hamdieh M. Evaluation of Efficacy of Low-Level Laser Therapy. J Lasers Med Sci. 2020 Fall;11(4):369-380. doi: 10.34172/jlms.2020.60. Epub 2020 Oct 3. — View Citation

Robbins SR, Alfredo PP, Junior WS, Marques AP. Low-level laser therapy and static stretching exercises for patients with knee osteoarthritis: A randomised controlled trial. Clin Rehabil. 2022 Feb;36(2):204-213. doi: 10.1177/02692155211047017. Epub 2021 Oct 29. — View Citation

Vogel DDS, Ortiz-Villatoro NN, Araujo NS, Marques MJG, Aimbire F, Scorza FA, Scorza CA, Albertini R. Transcranial low-level laser therapy in an in vivo model of stroke: Relevance to the brain infarct, microglia activation and neuroinflammation. J Biophotonics. 2021 Jun;14(6):e202000500. doi: 10.1002/jbio.202000500. Epub 2021 Mar 8. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Ashwarth scale	Use: The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity	6th week
Primary	Wisconsin gait scale	Use: The Wisconsin Gait Scale (WGS) can be used to evaluate the gait problems experienced by a patient with stroke	6th week
Primary	Goniometer	Use: A goniometer is a device used in physical therapy to measure a joint's range of motion (ROM).	6th week