Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Western Aphasia Battery Score
研究概览
简要总结
The goal of this Interventional Study is to develop and test the Indian Adaptation of Melodic Intonation Therapy (MIT) for Indian patients in with post-stroke Non-Fluent Aphasia (PSNFA). The main question[s] it aims to answer are: • To develop the MIT Indian Adaptation tool and check its feasibility • To compare the MIT with standard speech rehabilitation in patient with PSNFA. Participants will undergo Speech Rehabilitation according to the developed module and the standard treatment will be given in the comparator arm. The speech recovery at 12 weeks will be compared in both treatment arms.
详细描述
The study will be done in two stages:
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Stage 1 (Intervention formulation): A battery for therapy will be formulated with the help of SLT in conjunction with the expert(s) in Indian music, neurologist, and physiologist. In a series of physical and online meetings, the duration, frequency, and content of the therapy programme will be formulated. The stage(s) at which NIRS will be conducted will also be decided. This will not involve any patient recruitment and should be finished in three months.
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Stage 2 (Feasibility phase): The feasibility run will be done in 10 eligible patients. With further adaptations depending upon the experience in the feasibility phase, the pilot phase will be conducted, in which the treatment arms will be randomized.
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Stage 2 (Pilot phase): Assuming standard error of measurement for participants with aphasia as 4.33 points with a 5-point difference considered clinically meaningful for the Western Aphasia Battery (WAB), and considering that no such prior study is there, 30 patients in intervention and control arm would be initially taken. Therefore, the total sample size 10+30+30=70 patients.
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The randomization will be done in 1:1 ratio, via a computer-generated random number sequence which will be in a sealed opaque envelope. The allocation will be concealed, and the treatment arm will be revealed after the patient has been screened and has consented for the study.
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The outcome assessment will be by a blinded assessor, who will be a co-investigator in the study.
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
- Single (Outcomes Assessor)
盲法说明
The outcome assessor will be blinded to the intervention
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All of the following
- •Age ≥18 years of age
- •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
- •Any of the following:
- •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
研究组 & 干预措施
Intervention
The intervention arm will be given the Music Therapy, the Indian language adapted module
干预措施: Speech rehabilitation (Other)
Active comparator
The active comparator arm will be given the standard speech rehabilitation.
干预措施: Speech rehabilitation (Other)
结局指标
主要结局
Western Aphasia Battery Score
时间窗: 8 weeks
次要结局
- Western Aphasia Battery Score(4 weeks)
- functional Near Red Spectroscopy measures(8 weeks)
- modified Rankin Score(8 weeks)
- Fugl Meyer Assessment Scores(8 weeks)
研究者
Deepti Vibha
Professor
All India Institute of Medical Sciences, New Delhi