Brief description of trial (Data source: BASEC)
Die Studie will untersuchen, wie sich tiergestützte Therapie auf das Bewusstsein von Patienten im minimally conscious state auswirkt. Dies wird anhand von Reaktionen auf das Betrachten oder die Interaktion mit einem Tier im Vergleich zu einem Massageball oder einem Roboter-Tier über folgende Parameter erhoben: frontale Gehirnaktivität, Hautleitfähigkeit, Herzrate und Verhaltensbeobachtung.
Es werden 20 Patienten im minimalem Bewusstseinszustand und 20 gesunde Probanden untersucht, wobei alle Patienten sowohl mit Tier als auch in der Kontrollsituation gemessen werden.
Health conditions investigated(Data source: BASEC)
Patienten mit einer schweren Bewusstseinsstörung (minimally conscious state) sowie gesunde Kontrollpersonen
Health conditions
(Data source: WHO)
Consciousness Disorder;Brain Injuries
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Tiergestützte Intervention: Anwesenheit und Interaktion mit einem Tier
Interventions
(Data source: WHO)
Other: animal-assisted activity;Other: control activity
Criteria for participation in trial
(Data source: BASEC)
Einschlusskriterien Patienten
• Patienten des REHAB Basel
• Schwere Bewusstseinsstörung im Bereich des minimally conscious state
• Mindestens 16-jährig
• Einverständnis von gesetzlichem Vertreter
Einschlusskriterien Vergleichsgruppe:
• Gesund
• Mindestens 18-jährig
Exclusion criteria
(Data source: BASEC)
• Medizinische Kontraindikationen für Tierkontakt wie Allergien, Phobien etc.
• Starke Veränderung der Medikation während der Studiendauer (bei Patienten)
• Erworbene Hirnschädigung (bei Vergleichsgruppe)
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria for patients:
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Inpatients of REHAB Basel with severe disorder of consciousness: minimal conscious
state defined via: Glasgow Coma Scale (GCS) / Coma Recovery Scale-Revised (Koma
Remissions Skala, KRS/KRS-S) / BAVESTA Score
- Minimum Age of 18 years
Inclusion Criteria for healthy participants:
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- History of acquired brain-injury
- Minimum age of 18 years
Exclusion Criteria:
- Enrolment of the investigator, his/her family members, employees and other dependent
persons,
- medical contraindications for contact with animals as allergy, phobia etc.
- If the patient's medication changes radically during the time of data collection (only
eligible for clinical participants)
-
Further information on trial
Date trial registered
Oct 4, 2017
Incorporation of the first participant
Feb 1, 2017
Recruitment status
Recruiting
Academic title
(Data source: WHO)
Neurovascular Reactions to Animal-assisted Therapy in Patients With Severe Disorders of Consciousness (DOC): a Randomized-controlled Trial
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Participant).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
Near-infrared spectroscopy (NIRS): oxygenated hemoglobin (O2HB), deoxygenated hemoglobin (HHB), total hemoglobin (HB) and blood oxygen saturation (O2Sat)
Secundary end point
(Data source: WHO)
Galvanic Skin Response
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Basel
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Karin Hediger
079 519 78 85
karin.hediger@unibas.ch
Contact for general information
(Data source: WHO)
Karin Hediger, Dr. phil.
Swiss TPH
0041795197885;0041 (0)795197885
karin.hediger@unibas.ch;k.hediger@rehab.ch
Contact for scientific information
(Data source: WHO)
Karin Hediger, Dr. phil.
Swiss TPH
0041795197885;0041 (0)795197885
karin.hediger@unibas.ch;k.hediger@rehab.ch
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
Date of authorisation by the ethics committee
01.06.2017
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2017-00540
Secondary ID (Data source: WHO)
AAT NIRS
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