Association of sleep disturbances on balance and cognition and quality of life in post stroke survivors.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Pittsburgh sleep quality index
研究概览
简要总结
The study titled “Association of Sleep Disturbances on Balance, Cognition, and Quality of Life in Post-Stroke Survivors” is an observational study conducted at Dr. D.Y. Patil Hospital and Research Center, Old Age Homes, local societies in Pimpri, and Dr. D.Y. Patil College of Physiotherapy, Pune. It aims to examine the impact of sleep disturbances, assessed using DSM-5 criteria, on balance, cognition, and quality of life among post-stroke survivors, as these deficits may hinder independence and slow rehabilitation. A total of 200 participants will be recruited through convenience sampling, with 100 in the observational group and 100 in the control group, the sample size calculated using Win Pepi version 11.65 at 95% confidence and 80% power. Outcome measures will include the Berg Balance Scale for balance, the Montreal Cognitive Assessment for cognition, and the SF-12 questionnaire for quality of life, thereby exploring whether improving sleep quality can enhance rehabilitation outcomes.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Individuals diagnosed with stroke by neurologist 2 Age 40 to 70 Years of individuals.
- •3 Individuals able to walk few steps with or without support.
- •4 Individuals able to follow commands.
- •5 Individuals fulfilling the criteria according to Diagnostic and statistical manual of mental disorders 5th edition of insomnia.
排除标准
- •Patients with significant pre-existing disabilities (e.g., severe motor impairments due to conditions other than stroke).
结局指标
主要结局
Pittsburgh sleep quality index
时间窗: Baseline Assessment
Berg balance scale
时间窗: Baseline Assessment
Montreal cognitive assessment
时间窗: Baseline Assessment
SF12
时间窗: Baseline Assessment
次要结局
未报告次要终点
研究者
Shivani Patil
Dr. D. Y. Patil College of Physiotherapy