BTX-A and Mirror Therapy for Chronic Stroke Spasticity

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Spastic Hemiplegia
• Intervention / Treatment: Drug: Botulinum toxin type A (Botox®, Allergan); Procedure: Mirror Therapy; Procedure: Sham Mirror Therapy

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34000
      • Liv hospital Vadistanbul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BTX-A and MİRROR THERAPY; 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.	Drug: 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.; Procedure: Mirror Therapy; 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.
Active Comparator: BTX-A + Sham Mirror Therapy; 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	Drug: 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.; Procedure: Sham Mirror Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 MONTH

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	6 MONTH

Collaborators and Investigators

• Sponsor: Fatih Sultan Mehmet Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Actual): February 15, 2025
• Study Completion (Actual): May 15, 2025

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: STROKE; MİRROR THERAPY; BOTULİNUM TOXİNS
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Hemiplegia; Amino Acids, Peptides, and Proteins; Proteins; Therapeutics; Biological Factors; Physical Therapy Modalities; Hydrolases; Enzymes; Enzymes and Coenzymes; Rehabilitation; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Metalloproteases; Bacterial Proteins; Bacterial Toxins; Toxins, Biological; Botulinum Toxins, Type A; Mirror Movement Therapy
• Other Study ID Numbers: FSM AYNA BOTULİNUM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No