NCT02599766

Brief Summary

The purpose is to investigate whether animal-assisted therapy has positive biopsychosocial effects on patients with brain injuries. This study investigates 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 25 patients over 24 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 who are in a slightly advanced rehabilitation process, assessed via their function profile, are investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

July 1, 2019

Completed
Last Updated

July 1, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

October 29, 2015

Results QC Date

April 20, 2018

Last Update Submit

April 4, 2019

Conditions

Impaired Social Functioning

Keywords

animal assisted intervention, brain injury, rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Social Functioning: Total Social Behavior

    Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of all social behaviors are collected and aggregated to one measure, the total social behavior.

    6 weeks

Secondary Outcomes (13)

  • Social Functioning: Verbal Communication

    6 weeks

  • Social Functioning: Nonverbal Communication

    6 weeks

  • Social Functioning: Physical Contact

    6 weeks

  • Social Functioning: Attention

    6 weeks

  • Positive Emotional Display

    6 weeks

  • +8 more secondary outcomes

Study Arms (2)

animal assisted therapy

EXPERIMENTAL

"Standard therapy" that is done in the presence and with integrating an animal.

Other: animal assisted therapy

standard therapy

ACTIVE COMPARATOR

"Standard therapy" without the presence of an animal.

Other: standard therapy

Interventions

animal assisted therapyOTHER

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

animal assisted therapy
standard therapyOTHER

standard physiotherapy, standard speech therapy and standard occupational therapy

standard therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient at REHAB Basel
  • brain-injury
  • willing to participate in animal-assisted therapies
  • physical and psychological resilience and ability to go/be transported outside to the "Therapie-Tiergarten"
  • ability to get in contact with the animal autonomously

You may not qualify if:

  • medical contraindications:allergies, phobias, etc.
  • no willingness to participate in animal-assisted therapies
  • patient might present a danger to the animals (aggressive behaviour)
  • 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)

  • Gocheva V, Hund-Georgiadis M, Hediger K. Effects of animal-assisted therapy on concentration and attention span in patients with acquired brain injury: A randomized controlled trial. Neuropsychology. 2018 Jan;32(1):54-64. doi: 10.1037/neu0000398. Epub 2017 Oct 16.

    PMID: 29035068DERIVED

MeSH Terms

Conditions

Brain Injuries

Interventions

Animal Assisted TherapyStandard of Care

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

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

Results Point of Contact

Title
Dr. Karin Hediger
Organization
Swiss TPH
karin.hediger@unibas.ch
0041795197885

Study Officials

  • Margret Hund-Georgiadis, PD Dr.

    Rehab Basel

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. phil.

Study Record Dates

First Submitted

October 29, 2015

First Posted

November 9, 2015

Study Start

February 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

July 1, 2019

Results First Posted

July 1, 2019

Record last verified: 2019-04

Locations

CH(1)