Clinical trial NCT04859998: Effects of Animal-assisted Therapy on the Physical Function and Communication of Adults With Autism
Official title: Effects of Animal-assisted Therapy on the Physical Function and Communication of Adults With Autism: a Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Autism
Keywords: dog-assisted
gait
postural
communication
Human-animal interaction
fall risk
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
Collaborators: name: Asociación de Padres de Personas Con Autismo (APNA)
name: Asociación Nuevo Horizonte
name: Federación Autismo Madrid
First posted: 2021-04-26
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: one control (adults with autism that continues with their daily living and therapies) and one experimental group (adults with autism that receive the intervention program added to their daily living and therapies).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in walking performance (10m)
timeFrame: At baseline and inmediately after the intervention (within 7 days after the last session)
measure: Changes in walking performance (6m)
timeFrame: At baseline and inmediately after the intervention (within 7 days after the last session)
Secondary outcomes:
measure: Changes in balance and risk of falling
timeFrame: At baseline and inmediately after the intervention (within 7 days after the last session)
measure: Changes in communication without dog
timeFrame: At baseline and inmediately after the intervention (within 7 days after the last session)
measure: Changes in communication with dog
timeFrame: During sessions (first, intermediate and last one)
measure: Changes in the ability to climb and descend stairs
timeFrame: At baseline and inmediately after the intervention (within 7 days after the last session)
measure: Changes in step length (6m)
timeFrame: At baseline and inmediately after the intervention (within 7 days after the last session)
measure: Changes in step length (10m)
timeFrame: At baseline and inmediately after the intervention (within 7 days after the last session)
measure: Changes in cadence (6m)
timeFrame: At baseline and inmediately after the intervention (within 7 days after the last session)
measure: Changes in cadence (10m)
timeFrame: At baseline and inmediately after the intervention (within 7 days after the last session)
measure: Changes in duration of phases in the gait cycle (6m)
timeFrame: At baseline and inmediately after the intervention (within 7 days after the last session)
measure: Changes in duration of phases in the gait cycle (10m)
timeFrame: At baseline and inmediately after the intervention (within 7 days after the last session)
Other outcomes:
Locations:
city: Móstoles
country: Spain
facility: King Juan Carlos University
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Daniel Collado-Mateo, PhD
role: PRINCIPAL_INVESTIGATOR
References: