NCT07331844

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Fatih Sultan Mehmet Training and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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. 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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-05-15
• Primary completion: 2025-02-15
• Completion: 2025-05-15
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

1 site across 1 country: Turkey (Türkiye)