NCT07331844Completed
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
Source: ClinicalTrials.gov · Last updated 12 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 25 Feb 2025
- Start date
- May 2024
- Primary completion date
- Feb 2025
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Diseases
- Stroke
- NCT number
- NCT07331844
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From May 2024 to the primary completion date, Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- History of multiple strokes
- Stroke due to a non-ischemic cause
Other
- Presence of neuromuscular pathology in the unaffected extremity
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liv hospital Vadistanbul Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.