StrokeLLLNCT07171788
Effects of Low Level Laser Therapy on Wrist Flexors Spasticity and Hand Functions in Patients With Stroke
A study testing low level laser therapy and selected physical therapy program in people with Stroke, run by Cairo University.
Trial 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 more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- low level laser therapy and selected physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Stroke
- Being tested
- low level laser therapy, selected physical therapy program
- Keywords
- low level laser therapy, wrist flexor spasticity, hand function, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laser therapyOther
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 programOther
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
| Study group | Role | What they receive |
|---|---|---|
| low level laser therapy | Experimental | twenty patients will receive low level laser therapy three times a week for 6 weeks Receives: Other: low level laser therapy; Other: selected physical therapy program |
| selected physical therapy program | Active comparator | twenty patients will recieve selected physical therapy program plus sham low level therapy three time a weeks for 6 weeks Receives: Other: selected physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
spasticity
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
Measured: up to 6 weeks
hand grip strength
hand held dynamometer will be used to assess hand grip strength
Measured: up to 6 weeks
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.
Measured: 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.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- low level laser therapy and selected phyisical therapy program
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Hassan Amin Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171788
- Sponsor's protocol ID
- P.T.REC/012/005969
- Acronym
- LLL
- Status last verified
- Sep 2025
- First submitted
- 6 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Level Laser Therapy on Wrist Flexors Spasticity and Hand Functions in Patients With Stroke
- ClinicalTrials.gov ID
- NCT07171788
- Acronym / sponsor ID
- LLL / P.T.REC/012/005969
- Conditions
- Stroke
- Keywords
- low level laser therapy, wrist flexor spasticity, hand function, stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- low level laser therapy and selected phyisical therapy program
| Arm | Type | Receives |
|---|---|---|
| low level laser therapy | Experimental | Other: low level laser therapy, Other: selected physical therapy programtwenty patients will receive low level laser therapy three times a week for 6 weeks |
| selected physical therapy program | Active comparator | Other: selected physical therapy programtwenty patients will recieve selected physical therapy program plus sham low level therapy three time a weeks for 6 weeks |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low level laser therapypatients 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 | Other | low level laser therapy |
| selected physical therapy programpatient 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 | Other | low level laser therapy, selected physical therapy program |
Primary outcome
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 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
hand grip strength
Time frame: up to 6 weeks
hand held dynamometer will be used to assess hand grip strength
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.
1 secondary outcome
pain intensity
Time frame: up to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing low level laser therapy and selected physical therapy program in people with Stroke, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact heba mohamed, master (01156365322, hebah9355@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spasticity (time frame: up to 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.