An interventional study of Animal-assisted therapy and Conventional therapy in Minimally Conscious State, sponsored by University of Basel. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by University of Basel · Not applicable, Interventional, and Treatment
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).
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:
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).
88 studies on the registry are indexed under Persistent Vegetative State; 20 are open to participants now.
This study's enrollment of 30 is close to the median of 30 across 55 interventional studies indexed under Persistent Vegetative State.
Browse Persistent Vegetative State studies →University of Basel is the lead sponsor of 62 studies on the registry; 10 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive three weeks of two AAT sessions, each lasting ca 30 minutes.
Other: Animal-assisted therapy
Patients receive three weeks of two control sessions, each lasting ca 30 minutes.
Other: Conventional 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.
Parallelled conventional therapy sessions (treatment as usual)
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 weeks
Behavioral reactions
Behaviour of the patients will be coded in Noldus Observer according to a strict ethogram. State behaviours will be reported in % (relative to the duration of a session) and count behaviours as total number of shown behaviours during a session.
Time frame: 3 weeks
Heart rate
Heart rate will be measured in peats per minute using a Polar belt. HR is reported in beat per minutes (bpm).
Time frame: 3 weeks
Heart rate variability
Heart rate variability will be measured using a Polar belt. HRV is reported as mean RR intervals. The following HRV parameters will be calculated: time domain: the standard deviation of all normal-to-normal RR intervals (SDNN, ms) and root-mean square differences of successive RR intervals (RMSSD, ms); and frequency domain: relative power of the low frequency (LF) and high frequency (HF) band in normal units
Time frame: 3 weeks
Electrodermal activity (Galvanic Skin Response)
Electrodermal activity will be measured using the EMBRACE wristband. The outcome is reported in Microsiemens (sampling rate of 4Hz).
Time frame: 3 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jul 2019 to primary completion in Aug 2025, 72 months.
Of 23 interventional studies with no phase under Persistent Vegetative State, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 72. This study's 72 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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University of Basel