Music therapy for rehabilitation in post-stroke non-fluent aphasia: the Indian adaptation
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in the WAB score from baseline, at 4 weeks and at 8 weeks.
研究概览
简要总结
Stroke remains the second-leading cause of death and the third-leading cause of death and disability combined. The Global Burden of Disease Study indicates that the lower and lower-middle-income countries bear the brunt of disability. Aphasia and motor disability are the most crippling in stroke. Aphasia rehabilitation is often ignored and underplayed.
In India particularly, aphasia rehabilitation is sub-optimal due to a combination of lack of trained personnel and suitable adaptive strategies which are being practiced in the Western world. Music therapy has been shown to improve verbal fluency. However, there is no adapted and/or validated tool for the same in Indian patients. Not only the language, but the musical familiarity of the Indians is also very different from the West. The Indian ‘raags’, folk songs and popular music should be adapted to the aphasia rehabilitation program to engage the non-dominant hemisphere for non-fluent aphasia rehabilitation. The efficacy of this rehabilitation tool can be established by improvement in aphasia battery performance as well as by near infrared spectroscopy (NIRS).
We hypothesize that the Indian version of music rehabilitation module for non-fluent aphasia rehabilitation in post-stroke patients will improve their scores in Western Aphasia Battery (WAB) and functional near infrared spectroscopy (fNIRS). We propose to do this by initial formulation of the module by a team of expert speech and language therapists (SLTs) and neurologists. This will subsequently be pilot tested and optimized. Finally, a pilot randomized controlled trial of this intervention will be compared with standard speech rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Stroke with non-fluent aphasia, within one year of ictus
- •Imaging evidence suggestive of ischemic or hemorrhagic stroke of dominant hemisphere
- •Patient is alert and able to follow simple commands (should not have global aphasia)
- •Motivated caregiver
- •Informed and signed consent.
排除标准
- •Patients with a history of a previous stroke other than the index event, which can explain the aphasia.
- •Any clinical condition (e.g., short life expectancy, coexisting disease) or other characteristics that preclude appropriate follow-up in the study (e.g., distant residence, no family support)
- •Patients participating in any therapeutic intervention clinical trials evaluating poststroke recovery
- •Use of psychotropic drugs that interfere with patient evaluation.
结局指标
主要结局
Change in the WAB score from baseline, at 4 weeks and at 8 weeks.
时间窗: Change in the WAB score from baseline, at 4 weeks and at 8 weeks.
次要结局
- modified Rankin Scale(6 and 12 weeks)
- Fugl Meyer Score(6 and 12 weeks)
- WAB score(6 weeks)
- functional Near Red Spectroscopy analysis(12 weeks)
研究者
Deepti Vibha
All India Institute of Medical Sciences