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NCT Number: NCT07171788

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

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

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Key information

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Level Laser Therapy

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

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

Primary outcomes

  1. spasticity

    Time frame: up to 6 weeks

    Modified ashworth scale will be used to assess spaticity according the following criteria,0: No increase in muscle tone

    • Slight increase in muscle tone, with a catch and release or minimal resistance at the end of the range of motion when an affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested as a catch, followed by minimal resistance through the remainder (less than half) of the range of motion
    • A marked increase in muscle tone throughout most of the range of motion, but affected part(s) are still easily moved
    • Considerable increase in muscle tone, passive movement difficult
    • Affected part(s) rigid in flexion or extension
  2. hand grip strength

    Time frame: up to 6 weeks

    hand held dynamometer will be used to assess hand grip strength

  3. muscle stiffness

    Time frame: up to 6 weeks

    The MyotonPRO will be used to assess muscle stiffness. it is a new handheld device that conveniently assesses stiffness of muscles and tendons.the device effectively measures changes in muscle stiffness due to fatigue It is placed on the skin over the muscle. A brief, gentle tap from the probe causes the muscle to oscillate. The oscillations are analysed automatically by the device to calculate the muscle's mechanical characteristics, such as its tone, stiffness and how elastic it is.

Secondary outcomes

  1. pain intensity

    Time frame: up to 6 weeks

    A visual analogue scale will be used to assess pain. This scale is used to assess the severity of pain. It consists of a line, usually 10 cm long, ranging from no pain or discomfort (zero), to the worst pain (10) that the patient could feel.

Study contacts

Contact information is provided by the study sponsor or research team.

heba mohamed, master

CONTACT

[email protected]

01156365322

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Acronym: LLL

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 15, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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