Can light be the key to unlocking stiff muscles after stroke?
NCT ID NCT07784231
First seen Aug 25, 2026 · Last updated Sep 02, 2026 · Updated 4 times
Summary
This clinical trial investigates whether photobiomodulation, a non-invasive light therapy, can reduce muscle spasticity in adults who have had a stroke. About 42 participants with spastic hemiparesis will receive either active light therapy or a placebo treatment on their calf muscles, alongside standard rehabilitation. Researchers will measure changes in spasticity, pain, medication use, and muscle function over an 8-week period to see if this light-based approach offers any benefit.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Photobiomodulation therapy (low-level laser therapy) applied to the calf muscles
- What this could lead to
- If effective, this non-invasive light therapy could offer a new way to reduce muscle stiffness and pain after stroke, potentially improving mobility and quality of life.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not be conclusive or widely applicable. The therapy's benefits are uncertain, and there is a risk it may not outperform the placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2026
- Expected to finish
-
Jun 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults who have sustained a unilateral ischemic or hemorrhagic cortical motor stroke, with the diagnosis documented in the acute phase by computed tomography (CT) or magnetic resonance imaging (MRI); * Patients currently undergoing multidisciplinary rehabilitation at the Rehabilitation Center where the study will be conducted; * Patients presenting with a motor pattern of spastic hemiparesis secondary to stroke; * Patients demonstrating the ability to perform orthostatism (standing posture) or therapeutic or functional gait activity. Exclusion Criteria: * Presence of uncontrolled systemic diseases, including but not limited to cancer, active infections, or uncontrolled diabetes mellitus; * History of photosensitivity or known hypersensitivity to light exposure; * Triceps surae spasticity graded as 4 on the Modified Ashworth Scale (MAS) at the initial pre-screening assessment;Acute clinical instability or any acute medical condition requiring immediate intervention; * Fixed anatomical deformities of the ankle joint that preclude a minimum passive or active range of motion of at least 60 degrees; * Malnutrition or significant nutritional deficiencies;Acute clinical conditions with the potential to exacerbate spasticity, such as acute fractures, cutaneous ulcers, or acute infections;Presence of any other movement or tone disorder (e.g., dystonia, chorea, or parkinsonism) that could confound spasticity assessments; * Exposed tumors or undiagnosed lesions in the area to be irradiated; * Change in the pharmacological class of antispastic medications during the therapeutic period of the study. Dose adjustments within the same medication class will be permitted and documented; * Administration of botulinum toxin type A injections into the triceps surae muscle during the study period or within six months prior to study enrollment; * Discontinuation of the concomitant physical therapy rehabilitation program, even if the participant continues to receive photobiomodulation per the study protocol; * Occurrence of any adverse event attributable to photobiomodulation; * Death; * Withdrawal of informed consent.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for NIRS are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
CER II Guarulhos
RECRUITINGSão Paulo, São Paulo, 05020-000, Brazil
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Effects of transcranial direct current stimulation and pelvic proprioceptive neuromuscular facilitation on trunk control, balance and functional mobility in stroke patients
- Correlation of visual and motor deficits in stroke patients
- Pilot study on the effects induced by an electromyographic-controlled functional electrical stimulator (FitFES) for upper limb rehabilitation in post-stroke patients
- Brazilian version of a behavior change intervention to support healthy lifestyle adoption after stroke - iVIDAVC: protocol for a pilot randomized study
- Determination of efficacy of sustained motor contraction generated using StimWave peripheral nerve stimulator
- Can a PET tracer reveal hidden brain inflammation?