StrokeLLLT-STROKENCT07273591
Effects of Low-level Laser Therapy on Spasticity and Gait Parameters in Chronic Stroke Patients With Spastic Plantar Flexors
A study testing Low Level Laser Therapy and conventional physical therapy in people with Stroke and Spasticity, run by Montiha Azeem at 1 site in Pakistan.
Trial summary
Stroke is one of the leading causes of long-term disability worldwide. Many patients who survive a stroke experience muscle stiffness (called spasticity), especially in the ankle and foot muscles, which makes walking difficult and painful. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Spasticity, Plantar Flexors
- What is being tested?
- Low Level Laser Therapy and conventional physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Dec 2025to 21 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with Age of 45-70 years. Male and female patients with chronic stroke. Patients determined to have persistent stroke for no less than 1 year A maximum of 2 degrees of plantar flexor spasticity on MAS. (35) Cognitive preserved, having score of 24 to 30 on MMSE. (25) Medical referral for physiotherapy.
Who cannot join
- Patients with uncontrolled metabolic illnesses, orthopedic issues, and other neurologic abnormalities should be excluded as potential confounding factors impacting balance performance. Patients with recurrent stroke. Patients who were at that point performing organized proactive tasks, for example, muscle reinforcing works out, Pilates, yoga or focused energy oxygen consuming activities Patients with Hypoesthesia or possibly Hyperesthesia of the side to be analyzed.
- The patients with active contamination and presence of rashes at the site of utilization of the laser application. A neoplastic lesion at the site of application.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shalamar Hospital, Sughra Shafi Medical Complex, Narowal
Lahore, Punjab Province, 54000
About this study
Stroke is one of the leading causes of long-term disability worldwide. Many patients who survive a stroke experience muscle stiffness (called spasticity), especially in the ankle and foot muscles, which makes walking difficult and painful. Spasticity in the plantar flexor muscles those that help push the foot down can lead to poor balance, limited mobility, and increased risk of falls.
This study aims to explore the effects of low-level laser therapy (LLLT) on spasticity and walking ability in patients who have had a stroke for more than six months (chronic stroke). LLLT is a non-invasive, painless treatment that uses low-intensity light to stimulate tissue healing, reduce muscle tightness, and improve nerve function.
Read more
A total of 18 chronic stroke patients with spastic plantar flexors were included in this randomized controlled trial (RCT). Participants were randomly assigned to one of two groups:
Study group: Received low-level laser therapy along with conventional physiotherapy.
Control group: Received conventional physiotherapy alone. Each patient received therapy for three weeks. The study evaluated outcomes using the Modified Ashworth Scale (MAS) for muscle spasticity, the Wisconsin Gait Scale (WGS) for walking quality, and a Goniometer for ankle joint range of motion. Assessments were done before and after treatment.
The results showed that both groups improved significantly, but patients who received laser therapy demonstrated greater reduction in spasticity and better gait performance compared to those who received conventional therapy alone.
This study suggests that low-level laser therapy can be a useful addition to conventional rehabilitation programs for improving walking ability and reducing spasticity in stroke patients.
Read the detailed description
Background and Rationale:
After a stroke, damage to the brain can cause increased muscle tone (spasticity), reduced mobility, and altered gait patterns. These issues significantly affect independence and quality of life. Traditional physiotherapy techniques, such as stretching and strengthening, are helpful but often insufficient in chronic cases. Recent evidence suggests that low-level laser therapy (LLLT) can promote cellular recovery, improve blood circulation, and reduce muscle stiffness by enhancing nerve conduction and reducing inflammation.
Study Objective:
To determine the effectiveness of low-level laser therapy in improving spasticity and gait parameters in chronic stroke patients with spastic plantar flexors.
Study Design:
This was a randomized controlled trial conducted on 18 participants diagnosed with chronic stroke and presenting with spasticity of the ankle plantar flexors. Participants were divided into:
Study group (n=9): Received low-level laser therapy (parameters: wavelength 830 nm, power output 50 mW, energy density 6 J/cm²) combined with conventional physiotherapy.
Control group (n=9): Received conventional physiotherapy only (stretching, strengthening, and gait training).
Intervention Duration:
Both groups received treatment sessions five times a week for three weeks.
Outcome Measures:
Spasticity: Measured using the Modified Ashworth Scale (MAS) Gait Parameters: Measured using the Wisconsin Gait Scale (WGS) Ankle Range of Motion (ROM): Measured with a Goniometer
Data Analysis:
Within-group changes were assessed using Friedman's test, and between-group comparisons were made using the Mann-Whitney U test. A p-value ≤ 0.05 was considered statistically significant. Statistical analysis was performed using SPSS version 25.
Results Summary:
Both groups showed significant improvements in spasticity, ankle range of motion, and gait scores; however, the study group demonstrated greater gains in all parameters. The combination of LLLT with physiotherapy enhanced motor control, reduced stiffness, and improved walking quality more effectively than physiotherapy alone.
Conclusion:
Low-level laser therapy is a safe, effective, and non-invasive intervention that significantly improves spasticity and gait in chronic stroke patients. Incorporating LLLT into rehabilitation programs may help enhance mobility and functional independence.
- Conditions
- Stroke, Spasticity, Plantar Flexors
- Being tested
- Low Level Laser Therapy, conventional physical therapy
- Keywords
- Chronic stroke, Low-level LASER therapy, planter flexors, spasticity, gait abnormalities
- Medical subject headings
- Stroke, Muscle Spasticity, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyDevice
Also called LLLT, Infrared laser therapy, photobiomodulation
Patients were in prone position while we applied low level laser therapy in continues wave at a wavelength in the near infrared of 830nm. Power density was 670 mW/cm2. The treatment time per point was 30 seconds. Probe head was placed at 90 degree with light pressure on the calf muscles. Three consecutive treatments were given in a session, with 5 seconds break in between, giving a total irradiation time of 90 seconds. Three sessions were given per week for total of six weeks
conventional physical therapyOther
Also called routine physiotherapy, traditional physical therapy
Participants in control group received conventional physical therapy for spasticity that was consisted of heating modality for 20 minutes followed by ten repetitions of sustained stretching of calf muscles (10 seconds hold), strengthening exercise for lower limb muscles i.e. calf muscles, hamstrings, and quadriceps, balance training on balance board and training of gait in parallel bars and using the stepper for six weeks and three sessions each week.
| Study group | Role | What they receive |
|---|---|---|
| conventional physical therapy | Active comparator | Participants in control group received conventional physical therapy for spasticity that was consisted of heating modality for 20 minutes followed by ten repetitions of sustained stretching of calf muscles (10 seconds hold), strengthening exercise for lower limb muscles i.e. calf muscles, hamstrings, and quadriceps, balance training on balance board and training of gait in parallel bars and using the stepper for six weeks and three sessions each week Receives: Other: conventional physical therapy |
| low level laser therapy | Experimental | Patients were in prone position while we applied low level laser therapy in continues wave at a wavelength in the near infrared of 830nm. Power density was 670 mW/cm2. The treatment time per point was 30 seconds. Probe head was placed at 90 degree with light pressure on the calf muscles. Three consecutive treatments were given in a session, with 5 seconds break in between, giving a total irradiation time of 90 seconds. Three sessions were given per week for total of six weeks Receives: Device: Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spasticity of Ankle Plantar Flexors Measured by Modified Ashworth Scale (MAS)
Spasticity of the ankle plantar flexors will be assessed using the Modified Ashworth Scale (MAS), a standardized clinical measure of muscle tone. Scores range from 0 (no increase in tone) to 4 (rigid in flexion or extension). Measurements will be taken at baseline, at 3 weeks, and at 6 weeks after the start of intervention. A decrease in MAS score will indicate improvement in spasticity.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start30 Dec 2025
- Primary completion15 Feb 2026
- Study completion21 Feb 2026
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.
- 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
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montiha Azeem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Montiha Azeem, University of Lahore
- Investigators
- Montiha Azeem, DPT, Principal investigator, The University of Lahore, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273591
- Sponsor's protocol ID
- REC-UOL-/544-08/24
- Acronym
- LLLT-STROKE
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low-level Laser Therapy on Spasticity and Gait Parameters in Chronic Stroke Patients With Spastic Plantar Flexors
- ClinicalTrials.gov ID
- NCT07273591
- Acronym / sponsor ID
- LLLT-STROKE / REC-UOL-/544-08/24
- Conditions
- Stroke, Spasticity, Plantar Flexors
- Keywords
- Chronic stroke, Low-level LASER therapy, planter flexors, spasticity, gait abnormalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Montiha AzeemUniversity, hospital or other
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 21 Feb 2026 (actual)
- First posted
- 9 Dec 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.
Stroke is one of the leading causes of long-term disability worldwide. Many patients who survive a stroke experience muscle stiffness (called spasticity), especially in the ankle and foot muscles, which makes walking difficult and painful. Spasticity in the plantar flexor muscles those that help push the foot down can lead to poor balance, limited mobility, and increased risk of falls.
This study aims to explore the effects of low-level laser therapy (LLLT) on spasticity and walking ability in patients who have had a stroke for more than six months (chronic stroke). LLLT is a non-invasive, painless treatment that uses low-intensity light to stimulate tissue healing, reduce muscle tightness, and improve nerve function.
A total of 18 chronic stroke patients with spastic plantar flexors were included in this randomized controlled trial (RCT). Participants were randomly assigned to one of two groups:
Study group: Received low-level laser therapy along with conventional physiotherapy.
Control group: Received conventional physiotherapy alone. Each patient received therapy for three weeks. The study evaluated outcomes using the Modified Ashworth Scale (MAS) for muscle spasticity, the Wisconsin Gait Scale (WGS) for walking quality, and a Goniometer for ankle joint range of motion. Assessments were done before and after treatment.
The results showed that both groups improved significantly, but patients who received laser therapy demonstrated greater reduction in spasticity and better gait performance compared to those who received conventional therapy alone.
This study suggests that low-level laser therapy can be a useful addition to conventional rehabilitation programs for improving walking ability and reducing spasticity in stroke patients.
Detailed description
Background and Rationale:
After a stroke, damage to the brain can cause increased muscle tone (spasticity), reduced mobility, and altered gait patterns. These issues significantly affect independence and quality of life. Traditional physiotherapy techniques, such as stretching and strengthening, are helpful but often insufficient in chronic cases. Recent evidence suggests that low-level laser therapy (LLLT) can promote cellular recovery, improve blood circulation, and reduce muscle stiffness by enhancing nerve conduction and reducing inflammation.
Study Objective:
To determine the effectiveness of low-level laser therapy in improving spasticity and gait parameters in chronic stroke patients with spastic plantar flexors.
Study Design:
This was a randomized controlled trial conducted on 18 participants diagnosed with chronic stroke and presenting with spasticity of the ankle plantar flexors. Participants were divided into:
Study group (n=9): Received low-level laser therapy (parameters: wavelength 830 nm, power output 50 mW, energy density 6 J/cm²) combined with conventional physiotherapy.
Control group (n=9): Received conventional physiotherapy only (stretching, strengthening, and gait training).
Intervention Duration:
Both groups received treatment sessions five times a week for three weeks.
Outcome Measures:
Spasticity: Measured using the Modified Ashworth Scale (MAS) Gait Parameters: Measured using the Wisconsin Gait Scale (WGS) Ankle Range of Motion (ROM): Measured with a Goniometer
Data Analysis:
Within-group changes were assessed using Friedman's test, and between-group comparisons were made using the Mann-Whitney U test. A p-value ≤ 0.05 was considered statistically significant. Statistical analysis was performed using SPSS version 25.
Results Summary:
Both groups showed significant improvements in spasticity, ankle range of motion, and gait scores; however, the study group demonstrated greater gains in all parameters. The combination of LLLT with physiotherapy enhanced motor control, reduced stiffness, and improved walking quality more effectively than physiotherapy alone.
Conclusion:
Low-level laser therapy is a safe, effective, and non-invasive intervention that significantly improves spasticity and gait in chronic stroke patients. Incorporating LLLT into rehabilitation programs may help enhance mobility and functional independence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional physical therapy | Active comparator | Other: conventional physical therapyParticipants in control group received conventional physical therapy for spasticity that was consisted of heating modality for 20 minutes followed by ten repetitions of sustained stretching of calf muscles (10 seconds hold), strengthening exercise for lower limb muscles i.e. calf muscles, hamstrings, and quadriceps, balance training on balance board and training of gait in parallel bars and using the stepper for six weeks and three sessions each week |
| low level laser therapy | Experimental | Device: Low Level Laser TherapyPatients were in prone position while we applied low level laser therapy in continues wave at a wavelength in the near infrared of 830nm. Power density was 670 mW/cm2. The treatment time per point was 30 seconds. Probe head was placed at 90 degree with light pressure on the calf muscles. Three consecutive treatments were given in a session, with 5 seconds break in between, giving a total irradiation time of 90 seconds. Three sessions were given per week for total of six weeks |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Age of 45-70 years. Male and female patients with chronic stroke. Patients determined to have persistent stroke for no less than 1 year A maximum of 2 degrees of plantar flexor spasticity on MAS. (35) Cognitive preserved, having score of 24 to 30 on MMSE. (25) Medical referral for physiotherapy.
Key exclusion criteria (2 listed)
- Patients with uncontrolled metabolic illnesses, orthopedic issues, and other neurologic abnormalities should be excluded as potential confounding factors impacting balance performance. Patients with recurrent stroke. Patients who were at that point performing organized proactive tasks, for example, muscle reinforcing works out, Pilates, yoga or focused energy oxygen consuming activities Patients with Hypoesthesia or possibly Hyperesthesia of the side to be analyzed.
- The patients with active contamination and presence of rashes at the site of utilization of the laser application. A neoplastic lesion at the site of application.
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 TherapyAlso: LLLT, Infrared laser therapy, photobiomodulationPatients were in prone position while we applied low level laser therapy in continues wave at a wavelength in the near infrared of 830nm. Power density was 670 mW/cm2. The treatment time per point was 30 seconds. Probe head was placed at 90 degree with light pressure on the calf muscles. Three consecutive treatments were given in a session, with 5 seconds break in between, giving a total irradiation time of 90 seconds. Three sessions were given per week for total of six weeks | Device | low level laser therapy |
| conventional physical therapyAlso: routine physiotherapy, traditional physical therapyParticipants in control group received conventional physical therapy for spasticity that was consisted of heating modality for 20 minutes followed by ten repetitions of sustained stretching of calf muscles (10 seconds hold), strengthening exercise for lower limb muscles i.e. calf muscles, hamstrings, and quadriceps, balance training on balance board and training of gait in parallel bars and using the stepper for six weeks and three sessions each week. | Other | conventional physical therapy |
Primary outcome
Change in Spasticity of Ankle Plantar Flexors Measured by Modified Ashworth Scale (MAS)
Time frame: 6 weeks
Spasticity of the ankle plantar flexors will be assessed using the Modified Ashworth Scale (MAS), a standardized clinical measure of muscle tone. Scores range from 0 (no increase in tone) to 4 (rigid in flexion or extension). Measurements will be taken at baseline, at 3 weeks, and at 6 weeks after the start of intervention. A decrease in MAS score will indicate improvement in spasticity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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. This study is not recruiting at the moment.
Montiha Azeem, DPT principal investigator
The University of Lahore, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy and conventional physical therapy in people with Stroke and Spasticity, run by Montiha Azeem at 1 site in Pakistan.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Spasticity of Ankle Plantar Flexors Measured by Modified Ashworth Scale (MAS) (time frame: 6 weeks). 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 5 May 2026.