Integrating Animal-assisted Therapy in Stroke Rehabilitation: a Randomized Controlled Trial Assessing the Impact on Psychological State and Functional Recovery of Patients, as Well as Wellbeing of Therapy Dogs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change in Anxiety
研究概览
简要总结
The investigators hypothesize that the presence of a Mayo Clinic certified therapy dog will provide additional benefits above typical treatment for patients currently enrolled in the Mayo Clinic Stroke Rehabilitation Unit.
详细描述
The objectives of this study are to measure the effects of a therapy dog embedded in stroke rehabilitation sessions on the patients' functional recovery, depression, anxiety, motivation, and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be 18 years of age or older.
- •Patient must be in the comprehensive in-patient stroke rehabilitation program.
- •Patient must have a stroke from any cause.
- •Patients must be able and willing to give informed consent.
- •Patients must be able to speak English as the questionnaires being used are only available in English.
排除标准
- •Patient who has a pacemaker.
- •Patient who is pregnant.
- •Patient who is deemed inappropriate to the study by the medical professional.
- •Patient who is unable to give informed consent.
- •Patient who is unable to speak English.
结局指标
主要结局
Change in Anxiety
时间窗: Baseline through inpatient stay, an average of 2 weeks.
Change in anxiety from admission to discharge of hospital stay through use of the General Anxiety Disorder scale (GAD-7). GAD-7 scores range from 0 to 21 with higher scores indicating greater severity of anxiety.
Change in Quality of Life Outcomes
时间窗: Baseline through inpatient stay, an average of 2 weeks.
Change in quality of life outcomes from admission to discharge of hospital stay through the use of the Stroke Specific Quality of Life Scale (SSQLS). The SSQL has 49 items that covers 12 domains. The SSQL scores range from 49 to 245 with higher scores indicating a better health related quality of life.
Change in Depression
时间窗: Baseline through inpatient stay, an average of 2 weeks.
Change in depression from admission to discharge of hospital stay through the use of the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 scores range from 0 to 27 with higher scores indicating greater severity of depression.
Change in overall functional recovery
时间窗: Baseline through inpatient stay, an average of 2 weeks.
Change in overall functional recovery from admission to discharge of hospital stay through the use of the Self-Care and Mobility Quality Measures (SMQM). The SMQM is a clinician-rated instrument used to measure self-care and mobility measures. The clinician rates each item on a 6-point scale. A higher domain score indicates that the patient has a better independency in the functional performance of that domain.
Change in motivation
时间窗: Baseline through inpatient stay, an average of 2 weeks.
Change in motivation from admission to discharge of hospital stay through the use of the Pittsburgh Rehabilitation Participation Scale (PRRS). The PRRS is a clinician-rated instrument used to evaluate patients' participation in therapy. This questionnaire contains one item, asking therapists to rate the patient's effort and motivation during the therapy session based on a 6-point scale.
次要结局
未报告次要终点
研究者
Arya B. Mohabbat, M.D.
Principal Investigator
Mayo Clinic