NCT02629302

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 14, 2015

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 17, 2018

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

December 7, 2015

Last Update Submit

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.

Other: animal assisted therapy

standard therapy

ACTIVE COMPARATOR

standard physiotherapy, standard speech therapy and standard occupational therapy

Other: standard therapy

Interventions

physiotherapy, speech therapy and occupational therapy in the presence of an animal

animal assisted therapy

standard physiotherapy, speech therapy and occupational therapy

standard therapy

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Consciousness Disorders

Interventions

Animal Assisted TherapyStandard of Care

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Karin Hediger

    Rehab Basel

    PRINCIPAL INVESTIGATOR

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

Locations