Therapeutic Effects of Animal-assisted Therapy for Patients in a Minimally Conscious State

NCT03910959 | Completed DMC

• 1 other identifier: 2019-00350
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effects of animal-assisted occupational therapy on patient's consciousness, measured via the achievement of predefined, patient-specific goals. 30 patients in a minimally conscious state will be included in this trial with randomized, controlled cross-over design. Patients will be randomized and allocated to either study arm 1 or 2 with an allocation ratio 1/1. In study arm 1, patients (N=15) receive three weeks of two AAT sessions per week followed by three weeks of two control sessions (TAU) per week. In study arm 2, patients (N=15) receive three weeks of two control sessions (TAU) per week followed by three weeks of two AAT sessions per week. Each session lasts 30 minutes. Goal attainment and secondary outcomes will be measured before the study start (pre-measurement, t0), at the end of the first 3 weeks therapy (post-measurement I, t1), at the start of the second 3 weeks (pre-measurement II, t2) as well as at the study end (post-measurement II, t3).

Conditions

Minimally Conscious State

Outcome Measures

Primary Outcomes (3)

• Amount of goal achievement l: CSR-R

  The goal achievement will be assessed via the JFK Coma Remission Scale revised (CSR-R), with 6 subscales and a total score ranging from 0 to 23 with higher scores indicating better outcomes.

  3 weeks

• Amount of goal achievement II: BAVESTA

  The goal achievement will be assessed via the Basler Vegetative State Assessment. The scale ranges from 0 to 5 with higher scores indicating better outcomes.

  3 weeks

• Amount of goal achievement III: VAS

  The goal achievement will also be assessed via a Visual Analogue Scale where a cross can be made on a line (measured in millimeters, ranging from 0 to 25) with higher values indicating better outcome.

  3 weeks

Secondary Outcomes (4)

• Behavioral reactions

  3 weeks

• Heart rate

  3 weeks

• Heart rate variability

  3 weeks

• Electrodermal activity (Galvanic Skin Response)

  3 weeks

Study Arms (2)

Animal-assisted therapy

EXPERIMENTAL

Patients receive three weeks of two AAT sessions, each lasting ca 30 minutes.

Other: Animal-assisted therapy

treatment as usual

ACTIVE COMPARATOR

Patients receive three weeks of two control sessions, each lasting ca 30 minutes.

Other: Conventional therapy

Interventions

Animal-assisted therapy OTHER

Therapy in the presence and with interaction with an animal. Involved animals can be all species that live at REHAB Basel and are part of the AAT program. All animals are trained for the specific service with vulnerable patients.

Animal-assisted therapy

Conventional therapy OTHER

Parallelled conventional therapy sessions (treatment as usual)

treatment as usual

Eligibility Criteria

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

You may qualify if:

• Inpatients of REHAB Basel in a minimally conscious state
• Minimum age of 18 years
• Informed consent documented by signature by the patient's legal representative

You may not qualify if:

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

Sponsors & Collaborators

• University of Basel: lead

Study Sites (1)

REHAB Basel

Basel, Switzerland

Location

MeSH Terms

Conditions

Persistent Vegetative State

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; 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: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study has a randomized, controlled cross-over design.

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 10, 2019
• Study Start: July 10, 2019
• Primary Completion: August 8, 2025
• Study Completion: August 8, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

CH (1)