A Randomized, Controlled, Open-label, Parallel-group, Multi-center Study to Compare the Effect of Intrathecal Baclofen Therapy Versus Best Medical Treatment on Severe Spasticity in Post-stroke Patients After 6 Months Active Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 25
- 主要终点
- Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6
研究概览
简要总结
To demonstrate that Intrathecal Baclofen (ITB) Therapy, compared to Best Medical Treatment (BMT), has superior efficacy in the treatment of severe spasticity in adult post-stroke patients with generalized spastic hypertonia who have not reached their therapy goal with other treatment interventions assessed by a decrease in the average Ashworth Scale (AS) score in the lower extremities.
详细描述
This is a randomized, controlled open-label parallel group study to demonstrate the efficacy benefit of ITB Therapy over BMT in post-stroke patients with severe spasticity who have not reached their therapy goal with other treatment interventions.
In order to evaluate the efficacy benefit of ITB Therapy over BMT in post-stroke patients, a two-arm parallel group design will be applied. Patients will be equally randomized to one of two treatment arms:
- ITB Therapy arm; or
- BMT arm
The study consists of a run-in phase of 21 days for the BMT treatment arm and 2-25 days for the ITB Therapy treatment arm, followed by a 6 month active trial.
The BMT treatment arm will receive a combination of oral antispastic medication and physiotherapy. Patients must be prescribed at least one or a combination of the following oral antispastic medications: oral baclofen, tizanidine, diazepam (or other benzodiazepines) or dantrolene. Following the run-in phase, patients will enter the 6 month active trial.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ITB therapy
Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
干预措施: intrathecal baclofen (Drug)
结局指标
主要结局
Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6
时间窗: Baseline and month 6
AS is a manual test, measuring the resistance to passive movement about a joint with varying degrees of velocity. Scores range from 1-5, with 5 choices. A score of 1 indicates no resistance, and 5 indicates rigidity. The following muscle groups in the lower extremities were assessed: hip flexors, hip adductors, knee extensors, knee flexors, plantar flexors and ankle-dorsal flexors. Average AS was calculated as the average of AS scores of the 6 muscles of the affected lower extremity. Change in average AS in affected lower extremities from baseline to month 6 between ITB and BMT arm was assessed. Change= AS at month 6 - AS at baseline.
次要结局
- Change in Numeric Pain Rating Scale (NPRS) From Baseline to Month 6(Baseline and month 6)
- Number of Participants Who Achieved Their Primary Therapeutic Goal Assessed With the Goal Attainment Scale (GAS)(month 6)
- Change in Average 10 Meter Time Walking Test (10MTWT) From Baseline to Month 6(Baseline and month 6)
- Change in Euro QoL Group-5 Dimensional, 3 Level Version (EQ-5D-3L) From Baseline to Month 6(Baseline and month 6)
- Change in SF-12 (12-item Short Form) From Baseline to Month 6(Baseline and month 6)
- Therapy Satisfaction(month 6)
- Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance(baseline, month 3, month 6)
- Change in Average Ashworth Scale (AS) in Affected Upper Extremities From Baseline to Month 6(Baseline and month 6)
- Change in Stroke Specific Quality of Life (SS-QoL ) From Baseline to Month 6(Baseline and month 6)
- Change in Functional Independence Measure (FIM) Score From Baseline to Month 6(Baseline and month 6)
- Healthcare Resource Utilization(baseline, ITB test (only ITB arm), second assessment (only BMT arm), week 6 (only ITB arm), month 3, month 6)