Effects of Animal Assisted Therapy on Patients With Severe Disorders of Consciousness
Effects of Animal-assisted Therapy in Patients With Severe Disorders of Consciousness at REHAB Basel: a Randomised-controlled Trial
1 other identifier
interventional
10
1 country
1
Brief Summary
The study investigates the effects of animal-assisted therapy on patients with severe disorders of consciousness. The focus lies on the short-term biopsychosocial effects that occur when animals are present during therapy sessions in comparison to therapy sessions without animals, observing a group of 10 patients during 16 therapy sessions. While half of the sessions are held in presence of an animal and half without, they are as comparable as possible with respect to content and setting. In this study, patients in a minimal conscious state are recruited.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2015
CompletedFirst Posted
Study publicly available on registry
December 14, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedMay 17, 2018
October 1, 2017
1.2 years
December 7, 2015
May 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Degree of consciousness
assessed via behavioral coding in Noldus Observer
4 weeks
Secondary Outcomes (2)
Heart rate
4 weeks
Behavioral reaction
4 weeks
Study Arms (2)
animal assisted therapy
EXPERIMENTAL"Standard" therapy (speech therapy, occupational therapy and physiotherapy) that is done in the presence and with Integration of an animal.
standard therapy
ACTIVE COMPARATORstandard physiotherapy, standard speech therapy and standard occupational therapy
Interventions
physiotherapy, speech therapy and occupational therapy in the presence of an animal
standard physiotherapy, speech therapy and occupational therapy
Eligibility Criteria
You may qualify if:
- Inpatients of REHAB Basel
- Disorder of consciousness: minimal conscious state defined via:
- CRS Score (Coma Remission Scale) of auditory 3-4 or visual 2-5 or motor 3-5 or oromotor/verbal = 3 or communication = 1
- BAVESTA Score of 2.8
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
REHAB Basel
Basel, 4012, Switzerland
Related Publications (1)
Hediger K, Petignat M, Marti R, Hund-Georgiadis M. Animal-assisted therapy for patients in a minimally conscious state: A randomized two treatment multi-period crossover trial. PLoS One. 2019 Oct 1;14(10):e0222846. doi: 10.1371/journal.pone.0222846. eCollection 2019.
PMID: 31574106DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karin Hediger
Rehab Basel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2015
First Posted
December 14, 2015
Study Start
January 1, 2016
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
May 17, 2018
Record last verified: 2017-10