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临床试验/NCT04859998
NCT04859998Unknown不适用

Effects of Animal-assisted Therapy on the Physical Function and Communication of Adults With Autism: a Controlled Trial.

Daniel Collado-Mateo2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年4月26日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
24
试验地点
2
主要终点
Changes in walking performance (6m)

研究概览

简要总结

The aim is to evaluate the effects of a dog-assisted therapy program on physical function and communication in a sample comprised of 24 adults with autism spectrum disorder. The sample will be divided into 2 groups, a control group and an experimental group. Changes after 10 weeks (20 sessions) will be compared between-groups.

详细描述

The intervention program will consist of 20 sessions conducted twice a week in the facilities of the collaborator associations. Each session will be conducted in groups of 3 participants and will last 30 minutes. It will include a welcome part, a main part (based on different activities and physical exercises with the dog) and a closing part to say goodbye to the dogs.

Physical function measures will be conducted before and after the completion of the study. The interaction and communication will be assessed during the sessions in the first, tenth and last ones.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

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

入选标准

  • Older than 40 years
  • With autism spectrum disorder
  • Able to walk autonomously, without help from other people.
  • Able to climb and descent stairs autonomously, without help from other people.

排除标准

  • Medical condition that contraindicates the proximity or contact with the animals with the animals on the part of the user.
  • Allergy to dog epithelium.
  • Phobias to dogs.
  • History of aggression to animals.
  • Users who do not submit a signed informed consent form.

结局指标

主要结局

Changes in walking performance (6m)

时间窗: At baseline and inmediately after the intervention (within 7 days after the last session)

Evaluation of the ability to walk 6 meters in a corridor (time spent)

Changes in walking performance (10m)

时间窗: At baseline and inmediately after the intervention (within 7 days after the last session)

Evaluation of the ability to walk 10 meters in a corridor (time spent)

次要结局

  • Changes in balance and risk of falling(At baseline and inmediately after the intervention (within 7 days after the last session))
  • Changes in step length (6m)(At baseline and inmediately after the intervention (within 7 days after the last session))
  • Changes in communication with dog(During sessions (first, intermediate and last one))
  • Changes in step length (10m)(At baseline and inmediately after the intervention (within 7 days after the last session))
  • Changes in cadence (6m)(At baseline and inmediately after the intervention (within 7 days after the last session))
  • Changes in cadence (10m)(At baseline and inmediately after the intervention (within 7 days after the last session))
  • Changes in communication without dog(At baseline and inmediately after the intervention (within 7 days after the last session))
  • Changes in the ability to climb and descend stairs(At baseline and inmediately after the intervention (within 7 days after the last session))
  • Changes in duration of phases in the gait cycle (10m)(At baseline and inmediately after the intervention (within 7 days after the last session))
  • Changes in duration of phases in the gait cycle (6m)(At baseline and inmediately after the intervention (within 7 days after the last session))

研究者

发起方
Daniel Collado-Mateo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Daniel Collado-Mateo

Assistant Professor

Universidad Rey Juan Carlos

研究点 (2)

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