Disorder of ConsciousnessNCT02629302
Effects of Animal Assisted Therapy on Patients With Severe Disorders of Consciousness
A study testing animal assisted therapy and standard therapy in people with Disorder of Consciousness, run by Swiss Tropical & Public Health Institute at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Disorder of Consciousness
- What is being tested?
- animal assisted therapy and standard therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Animal-assisted Therapy in Patients With Severe Disorders of Consciousness at REHAB Basel: a Randomised-controlled Trial
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.
Read the detailed description
This pilot study is designed as a controlled cross-over, within-subject trial with repeated measurement. The experimental condition is the standardised therapy session using therapy animals (AAT), while the control condition is the comparable "standard" therapy session without the presence of an animal.
Over a period of four weeks, patients have four standardised therapy sessions per week, that alternate in a way that two sessions in two consecutive weeks are similar except for one is with the presence of animals and one without. In this way, data is collected over 16 therapy sessions (8 experimental, 8 control) for each patient.
Each therapy session lasts about 20 minutes.
The study takes place at REHAB Basel. Animal-assisted therapies are held in a special room at REHAB Basel in the presence of one or more small animals that will be selected by the therapist.
Patients are allocated randomly to start with either the experimental or the control condition.
- Conditions
- Disorder of Consciousness
- Being tested
- animal assisted therapy, standard therapy
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
animal assisted therapyOther
physiotherapy, speech therapy and occupational therapy in the presence of an animal
standard therapyOther
standard physiotherapy, speech therapy and occupational therapy
| Study group | Role | What they receive |
|---|---|---|
| animal assisted therapy | Experimental | "Standard" therapy (speech therapy, occupational therapy and physiotherapy) that is done in the presence and with Integration of an animal. Receives: Other: animal assisted therapy |
| standard therapy | Active comparator | standard physiotherapy, standard speech therapy and standard occupational therapy Receives: Other: standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of consciousness
assessed via behavioral coding in Noldus Observer
Measured: 4 weeks
Secondary outcomes (2)
Heart rate
assessed via non-invasive HR monitoring belts (Polar® RS800CX, Polar® Electro Oy)
Measured: 4 weeks
Behavioral reaction
measured via therapist's ratings on the BAVESTA scale (Basler Assessment Vegetative State)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Interdisciplinary Research on the Human-Pet Relationship, Rehab Basel
- Responsible party
- Sponsor
- Investigators
- Karin Hediger, Principal investigator, Rehab Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629302
- Sponsor's protocol ID
- EKNZ 2015-153
- Status last verified
- Oct 2017
- First submitted
- 7 Dec 2015
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31574106
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Animal-assisted Therapy in Patients With Severe Disorders of Consciousness at REHAB Basel: a Randomised-controlled Trial
- ClinicalTrials.gov ID
- NCT02629302
- Acronym / sponsor ID
- EKNZ 2015-153
- Conditions
- Disorder of Consciousness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- Institute for Interdisciplinary Research on the Human-Pet Relationship, Rehab Basel
- Study start
- Jan 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 14 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This pilot study is designed as a controlled cross-over, within-subject trial with repeated measurement. The experimental condition is the standardised therapy session using therapy animals (AAT), while the control condition is the comparable "standard" therapy session without the presence of an animal.
Over a period of four weeks, patients have four standardised therapy sessions per week, that alternate in a way that two sessions in two consecutive weeks are similar except for one is with the presence of animals and one without. In this way, data is collected over 16 therapy sessions (8 experimental, 8 control) for each patient.
Each therapy session lasts about 20 minutes.
The study takes place at REHAB Basel. Animal-assisted therapies are held in a special room at REHAB Basel in the presence of one or more small animals that will be selected by the therapist.
Patients are allocated randomly to start with either the experimental or the control condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| animal assisted therapy | Experimental | Other: animal assisted therapy"Standard" therapy (speech therapy, occupational therapy and physiotherapy) that is done in the presence and with Integration of an animal. |
| standard therapy | Active comparator | Other: standard therapystandard physiotherapy, standard speech therapy and standard occupational therapy |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| animal assisted therapyphysiotherapy, speech therapy and occupational therapy in the presence of an animal | Other | animal assisted therapy |
| standard therapystandard physiotherapy, speech therapy and occupational therapy | Other | standard therapy |
Primary outcome
Degree of consciousness
Time frame: 4 weeks
assessed via behavioral coding in Noldus Observer
2 secondary outcomes
Heart rate
Time frame: 4 weeks
Behavioral reaction
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Derived from this study: PubMed 31574106Hediger 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Hediger principal investigator
Rehab Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing animal assisted therapy and standard therapy in people with Disorder of Consciousness, run by Swiss Tropical & Public Health Institute at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of consciousness (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02629302, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2018.