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Stroke survivors: adding exercise to botox may improve arm function and quality of life

NCT ID NCT04975646

Symptom relief Sponsor: University Rehabilitation Institute, Republic of Slovenia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether a regular exercise program can improve the benefits of botulinum toxin (Botox) injections for arm stiffness after a stroke. About 70 stroke survivors with arm spasticity will receive Botox and then be randomly assigned to either a prescribed exercise routine or their usual activity for two weeks. Researchers will measure changes in movement, pain, and quality of life to see if the exercise adds extra value.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
botulinum toxin-A (Botox) plus prescribed exercise program
What this could lead to
If it works, this could show that adding a simple exercise routine to standard Botox injections helps stroke survivors move better and feel better day-to-day.
What could go wrong
This is a small, early-stage study with only 70 participants. The exercise period is just two weeks, so any benefits may be short-lived or hard to measure.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2021

Expected to finish

Oct 2026

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: * patient's or caregiver's approval * ischemic or hemorrhagic stroke diagnosed using head CT/MRI * at least one upper limb muscle spasticity (MAS ≥ 3) * candidate for BTX-A treatment or already given BTX-A in the past * patient's or caregiver's capability for goal attainment protocol cooperation (Mini Mental Examination ≥ 24 points) Exclusion Criteria: * aphasic patients without caregiver's presence * other neurological or musculoskeletal diseases that could affect the treatment outcome

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Conditions

The condition(s) this trial relates to.

hemorrhagic stroke ischemic stroke Muscle Spasticity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemorrhagic stroke Ischemic stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

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

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • University Rehabilitation Institute, Republic of Slovenia

    RECRUITING

    Ljubljana, 1000, Slovenia

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