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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07331844
Enrollment
30
Registered
2026-01-12
Start date
2024-05-15
Completion date
2025-05-15
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spastic Hemiplegia, Stroke

Keywords

STROKE, MİRROR THERAPY, BOTULİNUM TOXİNS

Brief 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.

Interventions

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.

PROCEDUREMirror 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.

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.

Sponsors

Fatih Sultan Mehmet Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
FUGL MAYER SCORE6 MONTHThe 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.

Secondary

MeasureTime frameDescription
ASHWORTH SCALE6 MONTHThe 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)
BRUNNSTROM LEVEL6 MONTHBrunnstrom 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026