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

NCT05425225 | Completed

• 1 other identifier: REC/Lhr/22/0227 Humza
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Muscle Spasticity; Gait Analysis; Low-Level Laser Therapy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Goniometer

  Use: A goniometer is a device used in physical therapy to measure a joint's range of motion (ROM).

  6th week

Study Arms (2)

Low level LASER therapy

EXPERIMENTAL

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

Other: Low level LASER therapy

Conventional physical therapy

ACTIVE COMPARATOR

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

Other: Conventional physical therapy

Interventions

Low level LASER therapy 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)

Low level LASER therapy

Conventional physical therapy 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

Conventional physical therapy

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Shalimar hospital Lahore,PSRD

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (12)

• 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.

  PMID: 31574822 BACKGROUND

• 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.

  PMID: 33425286 BACKGROUND

• 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.

  PMID: 34714175 BACKGROUND

• 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.

  PMID: 32273951 BACKGROUND

• 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.

  PMID: 22045511 BACKGROUND

• 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.

  PMID: 33580734 BACKGROUND

• 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.

  PMID: 28507373 BACKGROUND

• 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.

  PMID: 22807422 BACKGROUND

• 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.

  PMID: 27299571 BACKGROUND

• 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.

  PMID: 31823135 BACKGROUND

• 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.

  PMID: 25614133 BACKGROUND

• 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.

  PMID: 22967677 BACKGROUND

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Binash Afzal, PHD*

  Riphah international university lahore campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: March 4, 2022
• Primary Completion: September 15, 2022
• Study Completion: November 15, 2022
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)