Using Dogs to Promote Therapeutic Engagement During Inpatient Rehabilitation Following Pediatric Acquired Brain Injury: Understanding Mechanisms and Moderators of Treatment Response.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Patient Participation/engagement
研究概览
简要总结
Children requiring inpatient rehabilitation treatment following acquired brain injury (ABI) are at risk for poor engagement in rehabilitative therapies. A within subject crossover design will be used to determine whether involving dogs in physical and occupational therapies while receiving inpatient rehabilitation improves patient engagement, how involving dogs improves engagement, and identify who is most likely to benefit. This project addresses the critical need to establish an evidence base for animal-assisted therapies in pediatric rehabilitation, incorporates innovative methods, and has the potential to lead to improved clinical care for children and adolescents receiving intensive rehabilitation following ABI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis: Participants must be admitted to the inpatient rehabilitation unit for treatment of an acquired brain injury (TBI, brain tumor, infection, etc).
- •Consent: The family must provide informed consent by parents or legal guardians.
- •Assent: The child/adolescent must provide a signature indicating assent to participate in the study.
- •Age at the time of screening: 4-21 years old
- •Sex: includes both males and females
- •Responsiveness: Rancho score greater than 2 at the time of enrollment (as noted in the medical chart).
排除标准
- •Allergies: Patient has a significant allergy to dogs
- •Fear: Patient has a significant fear of dogs
- •Disease: Participant is on contact precautions or has a communicable disease that may pose a risk to the dog or dog handler or has a compromised immune system where interacting with the dog and/or handler would be of significant risk to the patient.
- •Medical History: History of developmental delay prior to ABI.
- •Behavioral History: Participant or family has a history of animal abuse or cruelty.
- •Responsiveness: Rancho score of 2 or less
结局指标
主要结局
Patient Participation/engagement
时间窗: throughout study completion - an average of 2 weeks
Patient engagement/participation will be assessed via the Pittsburgh Rehabilitation Participation Scale (PRPS) is a 6-item Likert-type, clinician-rated measure that quantifies observed patient participation/engagement in their therapy sessions. Therapists will report their observations regarding patient's completion of exercises, effort applied to exercises, and level of support needed to complete activities.
Objective Engagement rating.
时间窗: throughout study completion - an average of 2 weeks
An objective measure of session engagement assessed via behavioral coding of video recorded therapy sessions. Coders will provide an objective measure of engagement by rating the patient in-session engagement based on the PRPS. Behaviors reflective of ratings on the PRPS will be clearly operationalized with anchors for each rating clearly defined.
次要结局
- Patient-reported mood(throughout study completion - an average of 2 weeks)
- Automated mood assessment(throughout study completion - an average of 2 weeks)
- Objective mood assessment(throughout study completion - an average of 2 weeks)
- Physiological distress(throughout study completion - an average of 2 weeks)
- Salivary Oxytocin(throughout study completion - an average of 2 weeks)