Can light be the key to unlocking stiff muscles after stroke?

NCT ID NCT07784231

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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

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.

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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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • CER II Guarulhos

    RECRUITING

    São Paulo, São Paulo, 05020-000, Brazil

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