Long-term Effects of AAT in Patients With ABI

NCT ID: NCT03687671

Last Updated: 2024-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2024-06-20

Brief Summary

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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).

Detailed Description

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Conditions

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Acquired Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Animal-assisted therapy

The intervention is animal-assisted occupational therapy, animal-assisted physiotherapy or animal assisted speech therapy with different animals. All animals are trained for the specific service with vulnerable patients. There are guinea pigs, rabbits, miniature pigs, sheeps, goats, chicken, dogs, cats and horses.

Group Type EXPERIMENTAL

Animal-assisted therapy

Intervention Type OTHER

Animal-assisted occupational therapy, animal-assisted physiotherapy and animal assisted speech therapy with different animals. All animals are trained for the specific service with vulnerable patients. There are guinea pigs, rabbits, miniature pigs, sheeps, goats, chicken, dogs, cats and horses.

Treatment as usual (activation program)

As control intervention patients receive treatment as usual (TAU) in speech therapy, occupational therapy or physiotherapy. The control intervention is named activation program.

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type OTHER

Speech therapy, occupational therapy or physiotherapy

Interventions

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Animal-assisted therapy

Animal-assisted occupational therapy, animal-assisted physiotherapy and animal assisted speech therapy with different animals. All animals are trained for the specific service with vulnerable patients. There are guinea pigs, rabbits, miniature pigs, sheeps, goats, chicken, dogs, cats and horses.

Intervention Type OTHER

Treatment as usual

Speech therapy, occupational therapy or physiotherapy

Intervention Type OTHER

Other Intervention Names

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activation program

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rehab Basel

OTHER

Sponsor Role collaborator

University of Basel

OTHER

Sponsor Role collaborator

Swiss Tropical & Public Health Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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REHAB Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2018-01030

Identifier Type: -

Identifier Source: org_study_id

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