Clinical trial NCT03910959: Therapeutic Effects of Animal-assisted Therapy for Patients in a Minimally Conscious State
Official title: Therapeutic Effects of Animal-assisted Therapy for Patients in a Minimally Conscious State: a Randomized, Controlled Cross-over Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Minimally Conscious State
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study has a randomized, controlled cross-over design.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Amount of goal achievement l: CSR-R
timeFrame: 3 weeks
measure: Amount of goal achievement II: BAVESTA
timeFrame: 3 weeks
measure: Amount of goal achievement III: VAS
timeFrame: 3 weeks
Secondary outcomes:
measure: Behavioral reactions
timeFrame: 3 weeks
measure: Heart rate
timeFrame: 3 weeks
measure: Heart rate variability
timeFrame: 3 weeks
measure: Electrodermal activity (Galvanic Skin Response)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: REHAB Basel
Study officials:
References: