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Not yet recruitingNCT07171788LLLUpdated Sep 15, 2025

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

An interventional study of low level laser therapy and selected physical therapy program in Stroke, sponsored by Cairo University. Not yet recruiting. Open to participants aged 45 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
45 Years to 60 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Stroke

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Keywords

  • low level laser therapy
  • wrist flexor spasticity
  • hand function
  • stroke
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 40 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    low level laser therapy

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

    Other: low level laser therapy · Other: selected physical therapy program

  • Active comparator
    selected physical therapy program

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

    Other: selected physical therapy program

Interventions

  • Otherlow 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

  • Otherselected 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

06

What researchers measure

Primary outcomes

  1. spasticity

    Modified ashworth scale will be used to assess spaticity according the following criteria,0: No increase in muscle tone 1. 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 2. A marked increase in muscle tone throughout most of the range of motion, but affected part(s) are still easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension

    Time frame: up to 6 weeks

  2. hand grip strength

    hand held dynamometer will be used to assess hand grip strength

    Time frame: up to 6 weeks

  3. muscle stiffness

    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.

    Time frame: up to 6 weeks

Secondary outcomes

  1. pain intensity

    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.

    Time frame: up to 6 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07171788
Lead sponsor
Cairo University
Responsible party
Heba Hassan Amin Mohamed (principle investigator : heba hassan amin mohamed, Cairo University) — Principal investigator
First posted
Sep 15, 2025
Start date
Sep 15, 2025 (estimated)
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Sep 15, 2025

Study contacts

heba mohamed, master
Contact
hebah9355@gmail.com
01156365322

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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