Long-term Effects of AAT in Patients With ABI

NCT03687671 | Completed

• 1 other identifier: 2018-01030
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acquired Brain Injury

Outcome Measures

Primary Outcomes (1)

• socioemotional behaviour

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

  18 weeks

Secondary Outcomes (5)

• Social cognition

  18 weeks

• Therapy motivation

  18 weeks

• Quality of life score

  18 weeks

• Depression

  18 weeks

• Adherence to treatnemt

  6 weeks

Study Arms (2)

Animal-assisted therapy

EXPERIMENTAL

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.

Other: Animal-assisted therapy

Treatment as usual (activation program)

ACTIVE COMPARATOR

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

Other: Treatment as usual

Interventions

Animal-assisted therapy 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.

Animal-assisted therapy

Treatment as usual OTHER

Speech therapy, occupational therapy or physiotherapy

Also known as: activation program

Treatment as usual (activation program)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• Rehab Basel: collaborator
• University of Basel: collaborator

Study Sites (1)

REHAB Basel

Basel, Canton of Basel-City, 4055, Switzerland

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

Animal Assisted Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 27, 2018
• Study Start: November 1, 2018
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-10

Locations

CH (1)