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

NCT ID: NCT03910959

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-10
• Study Completion Date: 2025-08-08

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).

Detailed Description

Early rehabilitation is crucial for patients in a minimally conscious state (MCS). The reorganization of neuronal structures and the recovery of cognitive processes as well as emotional and physical functions are most important. To reach these goals, animal-assisted therapy (AAT) is part of the therapeutic concept at REHAB Basel. Regarding the results of our previous studies at REHAB Basel, patients with brain-injuries can profit from animal-assisted therapy in terms of socioemotional skills and therapy motivation. Furthermore, patients with severe disorder of consciousness showed more behavioural reactions and arousal during AAT compared to standard therapy sessions. However, there is no research investigating if AAT can help to facilitate reaching rehabilitation goals in patients in a MCS and therefore advance neurorehabilitation. Hence, this study investigates if animal-assisted occupational therapy can facilitate attainment of therapeutic goals.

The main outcome is the amount of achievement of predefined, patient-specific therapeutic goals. This will be measured via the JFK Coma Remission Scale revised (CSR-R), the Basler Vegetative State Assessment (BAVESTA) and on a goal attainment scale in %, filled out by the therapist.

Secondary outcomes are:

1. Behavioural reactions via behavioral video coding

2. Heart rate, Heart rate variability (HR/HRV)

3. Electrodermal activity (EDA) / Galvanic skin response (GSR)

The investigators will include 30 patients fulfilling the following inclusion criteria: Inpatients of REHAB Basel in a minimally conscious state (defined via the CRS-R according to the Aspen criteria); Minimum age of 18 years; Informed consent documented by signature by the patient's legal representative. The presence of any one of the following exclusion criteria will lead to exclusion of the participant: Medical contraindications for contact with animals such as allergy, phobia etc.); Enrollment of the investigator, his/her family members, employees and other dependent persons.

The study has a randomized, controlled cross-over design including 30 patients in a minimally conscious state. 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. Before starting the study arm 1 or 2 therapists will define individual therapy goals for each patient.

Measurements will be taken 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Animal-assisted therapy

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

Group Type: EXPERIMENTAL

Animal-assisted therapy

Intervention Type: 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.

treatment as usual

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

Group Type: ACTIVE_COMPARATOR

Conventional therapy

Intervention Type: OTHER

Parallelled conventional therapy sessions (treatment as usual)

Interventions

Animal-assisted therapy

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.

Intervention Type: OTHER

Conventional therapy

Parallelled conventional therapy sessions (treatment as usual)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Basel

OTHER

Sponsor Role: lead

Responsible Party

Dr. Karin Hediger

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

REHAB Basel

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

2019-00350

Identifier Type: -

Identifier Source: org_study_id