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临床试验/NCT03687671
NCT03687671已完成不适用

Long-term Effects on Socioemotional Skills of Animal-assisted Therapy in Patients With Acquired Brain Injury

Swiss Tropical & Public Health Institute2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
socioemotional behaviour

研究概览

简要总结

The aim of this study is to investigate weather patients treated with animal-assisted therapy show better socioemotional skills compared to treatment as usual.

70 patients will be allocated randomly to one of two groups (control group and intervention group). During 6 weeks, all patients get two therapy sessions (AAT vs. TAU) per week. The 35 patients in the control group will get treatment as usual (TAU) in speech therapy, occupational therapy or physiotherapy twice a week whereas the 35 patients in the intervention group will get the same therapies but there will be an animal included in the therapy sessions.

The main outcome is the amount of expressed emotion and interaction in a standardized social situation measured via behavioral video coding.

Measurements will be done before the first therapy session (pre-measurement, t0) and after the last therapy session (post-measurement, t1) of the 6 weeks of intervention. The follow-up measurement will be done 6 weeks (follow-up I, t2) and 12 weeks later (follow-up II, t3).

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)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Informed consent as documented signed by the patient or his/her legal representative
  • Inpatients of REHAB Basel with acquired brain injury and FIM-score over 60 (Funktionale Selbstständigkeitsmessung, Internationale Vereinigung für Assessment in der Rehabilitation, 1997)
  • Minimum age of 18 years

排除标准

  • Enrolment of the investigator, his/her family members, employees and other dependent persons
  • medical contraindications for contact with animals as allergy, phobia etc.

结局指标

主要结局

socioemotional behaviour

时间窗: 18 weeks

The amount of expressed emotion andsocial interaction in a standardized social situation measured via behavioral video coding.

次要结局

  • Adherence to treatnemt(6 weeks)
  • Quality of life score(18 weeks)
  • Social cognition(18 weeks)
  • Therapy motivation(18 weeks)
  • Depression(18 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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