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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- FUGL MAYER SCORE
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Botulinum toxin type A (Botox®, Allergan) (Drug)
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.
干预措施: Mirror Therapy (Procedure)
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
干预措施: Botulinum toxin type A (Botox®, Allergan) (Drug)
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
干预措施: Sham Mirror Therapy (Procedure)
结局指标
主要结局
FUGL MAYER SCORE
时间窗: 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.
次要结局
- ASHWORTH SCALE(6 MONTH)
- BRUNNSTROM LEVEL(6 MONTH)