Effects of Low Level Laser Therapy on Wrist Flexors Spasticity and Hand Functions in Patients With Stroke

NCT ID: NCT07171788

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2025-12-30

Brief Summary

this study will be conducted to investigate the effect of low level laser therapy (LLLT) on wrist flexors spasticity and hand functions in patient with stroke

Detailed Description

Spasticity is more often found in the flexors muscles of the upper limb (fingers, wrist, and elbow flexors) and extensor muscles of the lower limb (knee and ankle extensors). Wissel et al observed that spasticity developed most often in elbow (79%), wrist (66%), ankle (66%), and shoulder (58%).9 Lundstrom et al concluded that spasticity is observed more frequently in the upper extremities than in the lower extremities, and Urban et al found a higher degree of spasticity in the upper limb muscles. LLLT is thought to work through several mechanisms. Stimulating ATP production and increasing cellular energy. The therapy can cause vasodilation, improving circulation in the treated area. It may also reduce the production of inflammatory mediators and increase anti-inflammatory factors, while potentially stimulating the synthesis of growth-promoting factors that facilitate tissue healing, and renewal may be stimulated by this therapy. In the context of spasticity management, LLLT has garnered scientific interest as a possible intervention, although its efficacy remains under scrutiny .Hypothesized mechanisms of action include muscle tone reduction through enhanced circulation and decreased inflammation in muscular and adjacent tissues, potentially fostering the relaxation of hypertonic muscles. Certain research indicates that LLLT may modulate the release of neurotransmitters crucial to muscle contraction and relaxation processes.

Conditions

Stroke

Study Design

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

Study Groups

low level laser therapy

twenty patients will receive low level laser therapy three times a week for 6 weeks

Group Type: EXPERIMENTAL

low level laser therapy

Intervention Type: OTHER

patients will receive LLT. The LLLT system used in the study (ASA LASER M6) delivered 1.0 W in continuous wave at a wave length in the near infrared of 808 nm. The incident power density will be 670 mW/cm2.The probe head will held with light pressure in contact with the skin over the course of median nerve on the dysfunctional limb for 15 minutes. Protective goggles will be used to prevent direct eye contact of the laser beam. plus selected phyiscal therapy program

selected physical therapy program

Intervention Type: OTHER

patient will receive standard physical therapy program for wrist flexors spasticity post-stroke typically includes the following components: Passive stretching: Passive static or dynamic stretching of the wrist flexorss is the mainstay to reduce spasticity and Physical therapy exercises in form of specific techniques of proprioceptive facilitation, relaxation techniques, passive and self-passive motions, and proper limb positioning. plus sham low level laser therapy

selected physical therapy program

twenty patients will recieve selected physical therapy program plus sham low level therapy three time a weeks for 6 weeks

Group Type: ACTIVE_COMPARATOR

selected physical therapy program

Intervention Type: OTHER

patient will receive standard physical therapy program for wrist flexors spasticity post-stroke typically includes the following components: Passive stretching: Passive static or dynamic stretching of the wrist flexorss is the mainstay to reduce spasticity and Physical therapy exercises in form of specific techniques of proprioceptive facilitation, relaxation techniques, passive and self-passive motions, and proper limb positioning. plus sham low level laser therapy

Interventions

low level laser therapy

patients will receive LLT. The LLLT system used in the study (ASA LASER M6) delivered 1.0 W in continuous wave at a wave length in the near infrared of 808 nm. The incident power density will be 670 mW/cm2.The probe head will held with light pressure in contact with the skin over the course of median nerve on the dysfunctional limb for 15 minutes. Protective goggles will be used to prevent direct eye contact of the laser beam. plus selected phyiscal therapy program

Intervention Type: OTHER

selected physical therapy program

patient will receive standard physical therapy program for wrist flexors spasticity post-stroke typically includes the following components: Passive stretching: Passive static or dynamic stretching of the wrist flexorss is the mainstay to reduce spasticity and Physical therapy exercises in form of specific techniques of proprioceptive facilitation, relaxation techniques, passive and self-passive motions, and proper limb positioning. plus sham low level laser therapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• forty stroke patients with wrist flexors spasticity from both sex will be participate in this study
• Their age ranges from 45 to 60 years.
• Patients will be referred by neurological consultants.
• preserved cognitive system, i.e., ability to respond to verbal stimul
• Body mass index less than 30.
• Patients will be diagnosed by clinical and radiological examination.
• patients with wrist flexors spasticity according to modified ashworth scale score +1 to 2.

Exclusion Criteria

• Patients with contractures, fractures, rigidity, and deformity
• Patients with cognitive impairments.
• Patients with visual, auditory impairment affecting their ability to complete tasks.
• Uncontrolled Diabetic patient.
• Presence of hypoesthesia and/or hyperesthesia of the involved upper limb.
• Other major neurological condition (e.g., Spinal cord injury, multiple sclerosis, Epilepsy, Meningitis, and Brain tumor).
• presence of neoplastic lesions at the site of application

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Heba Hassan Amin Mohamed

principle investigator : heba hassan amin mohamed

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

heba mohamed, master

Role: CONTACT

hebah9355@gmail.com

01156365322

Other Identifiers

P.T.REC/012/005969

Identifier Type: -

Identifier Source: org_study_id