StrokeNCT07331844
BTX-A and Mirror Therapy for Chronic Stroke Spasticity
A study testing Botulinum toxin type A (Botox®, Allergan) and Mirror Therapy in people with Stroke and Spastic Hemiplegia, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Stroke is one of the leading causes of disability worldwide, particularly affecting the upper extremities and thus negatively impacting patients' activities of daily living and quality of life. Upper extremity spasticity, characterized by increased muscle tone and tendon reflexes, leads to functional limitations. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Spastic Hemiplegia
- What is being tested?
- Botulinum toxin type A (Botox®, Allergan) and Mirror Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2024to 15 May 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Diagnosis of unilateral ischemic stroke
- Under the routine medical follow-up of the same clinician who plans upper extremity BTX treatment based on standard medical indications
- At least 3 months post-stroke
- Signed informed consent form
- Mini-Mental State Examination (MMSE) score >24
- Fugl-Meyer Assessment score <55
- Modified Ashworth Scale (MAS) score of 1-4
Who cannot join
- Any prior BTX-A or other injections administered to the upper extremity Severe cognitive impairment or any mental disorder preventing effective communication
- Concurrent enrollment in another experimental treatment program
- Visual or motor deficits that would prevent the application of mirror therapy
- History of multiple strokes
- Presence of neuromuscular pathology in the unaffected extremity
- Stroke due to a non-ischemic cause
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Liv hospital Vadistanbul
Istanbul, Istanbul, 34000
About this study
Official title: The Combined Effect of Botulinum Toxin Type A and Mirror Therapy in the Management of Chronic-Phase Upper Extremity Spasticity After Ischemic Stroke: A Double-Blind, Controlled Study
Stroke is one of the leading causes of disability worldwide, particularly affecting the upper extremities and thus negatively impacting patients' activities of daily living and quality of life. Upper extremity spasticity, characterized by increased muscle tone and tendon reflexes, leads to functional limitations. While Botulinum Toxin Type A (BTX-A) is widely used to manage spasticity and can temporarily alleviate symptoms, it does not directly support neuroplasticity and often requires repeated injections.
Mirror therapy (MT) has emerged as a promising rehabilitation approach with the potential to stimulate motor recovery and cortical reorganization. It is hypothesized that combining MT with BTX-A injections may more effectively reduce spasticity and improve upper extremity function.
In this study, a randomized, sham-controlled, double-blind, prospective design was employed to investigate the effects of adding MT to BTX-A treatment on spasticity and upper extremity motor function in stroke patients. A total of 30 patients, who received BTX-A injections, were divided into two groups: an experimental group receiving mirror therapy and a control group receiving sham therapy (using transparent glass). All patients also underwent a standardized conventional rehabilitation program, and the BTX-A injection protocol was kept consistent. Treatment efficacy was evaluated by comparing pre-injection measurements with those at six months post-injection, using the Brunnstrom Scale, Modified Ashworth Scale (MAS), Fugl-Meyer Scale, and a hand dynamometer. The findings are expected to shed light on the potential benefits of simultaneous MT and BTX-A administration, including reducing injection frequency, and to guide more comprehensive approaches in the rehabilitation of chronic stroke.
- Conditions
- Stroke, Spastic Hemiplegia
- Being tested
- Botulinum toxin type A (Botox®, Allergan), Mirror Therapy, Sham Mirror Therapy
- Keywords
- STROKE, MİRROR THERAPY, BOTULİNUM TOXİNS
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type A (Botox®, Allergan)Drug
Botulinum toxin type A was administered via intramuscular injections into the spastic upper limb muscles based on clinical evaluation. Injection sites and dosages were individualized according to the distribution and severity of spasticity. All injections were performed prior to the rehabilitation interventions.
Mirror TherapyProcedure or surgery
Mirror therapy was performed with participants seated and both forearms placed on a table. A mirror was positioned between the limbs to create a visual illusion of movement of the affected limb by observing the movements of the unaffected limb.
Sham Mirror TherapyProcedure or surgery
Sham mirror therapy was performed using a transparent glass panel instead of a mirror, allowing visual feedback without inducing a mirror illusion. Session frequency and duration were identical to those of the mirror therapy group.
| Study group | Role | What they receive |
|---|---|---|
| BTX-A and MİRROR THERAPY | Active comparator | Participants were asked to sit in a chair and place both forearms on an exercise table with their elbows flexed at 90 degrees. To administer mirror therapy, the direct view of both the healthy and the hemiplegic hand and wrist was blocked using a partition method. A mirror was then placed between the two forearms, ensuring that the mirror image of the healthy-side wrist overlapped with the position of the hemiplegic-side wrist. By observing the healthy hand's movements through the mirror during the exercises, a visual movement illusion was created for the hemiplegic hand. Receives: Drug: Botulinum toxin type A (Botox®, Allergan); Procedure: Mirror Therapy |
| BTX-A + Sham Mirror Therapy | Active comparator | In the sham group, however, a transparent glass was used instead of a mirror, and participants were asked to watch the wrist movements of the paralyzed side through the glass, providing visual feedback without creating an illusion. The sham procedure was applied for the same duration using the transparent glass Receives: Drug: Botulinum toxin type A (Botox®, Allergan); Procedure: Sham Mirror Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
FUGL MAYER SCORE
The Fugl-Meyer Motor Section focuses on evaluating the motor functions of the upper and lower extremities in individuals who have had a stroke. The tests in this section are scored based on fundamental parameters such as muscle activity, synergy patterns, joint movement control, and coordination. The total motor score commonly reaches 66 points (although there are versions with different point ranges). A higher Fugl-Meyer Motor Section score reflects better motor function in the individual.
Measured: 6 MONTH
Secondary outcomes (2)
ASHWORTH SCALE
The Ashworth Scale is a clinical measurement tool used to objectively evaluate the level of spasticity. The scale is scored from 0 to 4 (including 1+). The higher the score, the greater the resistance to passive movement (indicating more pronounced spasticity)
Measured: 6 MONTH
BRUNNSTROM LEVEL
Brunnstrom evaluates the upper extremity and the hand separately in six fundamental stages. The upper extremity staging assesses synergy and movement capabilities of the shoulder, elbow, and wrist. The hand staging reflects the ability to grasp, release, and perform fine motor skills. As the stages advance over time (for example, progressing from Stage 3 to Stage 4), the effectiveness of rehabilitation and the patient's recovery process are monitored.
Measured: 6 MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start15 May 2024
- Primary completion15 Feb 2025
- Study completion15 May 2025
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331844
- Sponsor's protocol ID
- FSM AYNA BOTULİNUM
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 12 Jan 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combined Effect of Botulinum Toxin Type A and Mirror Therapy in the Management of Chronic-Phase Upper Extremity Spasticity After Ischemic Stroke: A Double-Blind, Controlled Study
- ClinicalTrials.gov ID
- NCT07331844
- Acronym / sponsor ID
- FSM AYNA BOTULİNUM
- Conditions
- Stroke, Spastic Hemiplegia
- Keywords
- STROKE, MİRROR THERAPY, BOTULİNUM TOXİNS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 12 Jan 2026 (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 disability worldwide, particularly affecting the upper extremities and thus negatively impacting patients' activities of daily living and quality of life. Upper extremity spasticity, characterized by increased muscle tone and tendon reflexes, leads to functional limitations. While Botulinum Toxin Type A (BTX-A) is widely used to manage spasticity and can temporarily alleviate symptoms, it does not directly support neuroplasticity and often requires repeated injections.
Mirror therapy (MT) has emerged as a promising rehabilitation approach with the potential to stimulate motor recovery and cortical reorganization. It is hypothesized that combining MT with BTX-A injections may more effectively reduce spasticity and improve upper extremity function.
In this study, a randomized, sham-controlled, double-blind, prospective design was employed to investigate the effects of adding MT to BTX-A treatment on spasticity and upper extremity motor function in stroke patients. A total of 30 patients, who received BTX-A injections, were divided into two groups: an experimental group receiving mirror therapy and a control group receiving sham therapy (using transparent glass). All patients also underwent a standardized conventional rehabilitation program, and the BTX-A injection protocol was kept consistent. Treatment efficacy was evaluated by comparing pre-injection measurements with those at six months post-injection, using the Brunnstrom Scale, Modified Ashworth Scale (MAS), Fugl-Meyer Scale, and a hand dynamometer. The findings are expected to shed light on the potential benefits of simultaneous MT and BTX-A administration, including reducing injection frequency, and to guide more comprehensive approaches in the rehabilitation of chronic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BTX-A and MİRROR THERAPY | Active comparator | Drug: Botulinum toxin type A (Botox®, Allergan), Procedure: Mirror TherapyParticipants were asked to sit in a chair and place both forearms on an exercise table with their elbows flexed at 90 degrees. To administer mirror therapy, the direct view of both the healthy and the hemiplegic hand and wrist was blocked using a partition method. A mirror was then placed between the two forearms, ensuring that the mirror image of the healthy-side wrist overlapped with the position of the hemiplegic-side wrist. By observing the healthy hand's movements through the mirror during the exercises, a visual movement illusion was created for the hemiplegic hand. |
| BTX-A + Sham Mirror Therapy | Active comparator | Drug: Botulinum toxin type A (Botox®, Allergan), Procedure: Sham Mirror TherapyIn the sham group, however, a transparent glass was used instead of a mirror, and participants were asked to watch the wrist movements of the paralyzed side through the glass, providing visual feedback without creating an illusion. The sham procedure was applied for the same duration using the transparent glass |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years
- Diagnosis of unilateral ischemic stroke
- Under the routine medical follow-up of the same clinician who plans upper extremity BTX treatment based on standard medical indications
- At least 3 months post-stroke
- Signed informed consent form
Key exclusion criteria (6 listed)
- Any prior BTX-A or other injections administered to the upper extremity Severe cognitive impairment or any mental disorder preventing effective communication
- Concurrent enrollment in another experimental treatment program
- Visual or motor deficits that would prevent the application of mirror therapy
- History of multiple strokes
- Presence of neuromuscular pathology in the unaffected extremity
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 |
|---|---|---|
| Botulinum toxin type A (Botox®, Allergan)Botulinum toxin type A was administered via intramuscular injections into the spastic upper limb muscles based on clinical evaluation. Injection sites and dosages were individualized according to the distribution and severity of spasticity. All injections were performed prior to the rehabilitation interventions. | Drug | BTX-A + Sham Mirror Therapy, BTX-A and MİRROR THERAPY |
| Mirror TherapyMirror therapy was performed with participants seated and both forearms placed on a table. A mirror was positioned between the limbs to create a visual illusion of movement of the affected limb by observing the movements of the unaffected limb. | Procedure or surgery | BTX-A and MİRROR THERAPY |
| Sham Mirror TherapySham mirror therapy was performed using a transparent glass panel instead of a mirror, allowing visual feedback without inducing a mirror illusion. Session frequency and duration were identical to those of the mirror therapy group. | Procedure or surgery | BTX-A + Sham Mirror Therapy |
Primary outcome
FUGL MAYER SCORE
Time frame: 6 MONTH
The Fugl-Meyer Motor Section focuses on evaluating the motor functions of the upper and lower extremities in individuals who have had a stroke. The tests in this section are scored based on fundamental parameters such as muscle activity, synergy patterns, joint movement control, and coordination. The total motor score commonly reaches 66 points (although there are versions with different point ranges). A higher Fugl-Meyer Motor Section score reflects better motor function in the individual.
2 secondary outcomes
ASHWORTH SCALE
Time frame: 6 MONTH
BRUNNSTROM LEVEL
Time frame: 6 MONTH
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 12 Jan 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin type A (Botox®, Allergan) and Mirror Therapy in people with Stroke and Spastic Hemiplegia, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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 8 inclusion and 6 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 12 Jan 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 Turkey (Türkiye). 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?
FUGL MAYER SCORE (time frame: 6 MONTH). 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 12 Jan 2026.