NCT07273591

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

December 30, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2026

Completed
Last Updated

May 5, 2026

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 19, 2025

Last Update Submit

May 3, 2026

Conditions

Keywords

Chronic strokeLow-level LASER therapyplanter flexorsspasticitygait abnormalities

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks

Study Arms (2)

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

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

Device: Low Level Laser Therapy

Interventions

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

Also known as: LLLT, Infrared laser therapy, photobiomodulation
low level laser 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.

Also known as: routine physiotherapy, traditional physical therapy
conventional physical therapy

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalamar Hospital, Sughra Shafi Medical Complex, Narowal

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

StrokeMuscle SpasticityMobility Limitation

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Montiha Azeem, DPT

    The University of Lahore, Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 19, 2025

First Posted

December 9, 2025

Study Start

December 30, 2025

Primary Completion

February 15, 2026

Study Completion

February 21, 2026

Last Updated

May 5, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations