NCT01441674

Brief Summary

The primary purpose for this study is to determine if children who receive Occupational Therapy while they are an inpatient in the hospital will be more motivated to participate in therapy as well as increase the amount of time they will work during that particular session when a therapy dog is present during their sessions. The investigators will also be collecting data regarding a child's heart rate and blood pressure prior to the session starting and ending to determine if having a therapy dog present also helps relax a child.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2011

Typical duration for phase_1

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

Study Start

First participant enrolled

January 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2011

Completed
8 months until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 14, 2014

Status Verified

February 1, 2014

Enrollment Period

2.9 years

First QC Date

January 28, 2011

Last Update Submit

February 13, 2014

Conditions

Keywords

Occupational Therapy

Outcome Measures

Primary Outcomes (1)

  • OT Participation scale

    The patients response to therapy can be measures using the following behavior domains (cognition, fine motor, activities and daily living, feeding skills, active range of motion/activities, and functional Transfers).

    4 days

Secondary Outcomes (1)

  • Vital Signs (Blood Pressure and heart rate)

    4 days

Study Arms (2)

Animal Assisted Therapy Visit 1

EXPERIMENTAL

Standard OT Therapy with Animal Assisted Therapy at Visit 1 and Not at Visit 2

Behavioral: Animal Assisted Therapy

Animal Assisted Therapy at Visit 2

EXPERIMENTAL

Standard OT Therapy with Animal Assisted Therapy at Visit 2 and not Visit 1

Behavioral: Animal Assisted Therapy

Interventions

There will be a therapy dog and dog trainer present working with the patient for the AAT arm.

Also known as: Group 1 and Group 2
Animal Assisted Therapy Visit 1Animal Assisted Therapy at Visit 2

Eligibility Criteria

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

You may qualify if:

  • Inpatient Occupational Therapy Referrals
  • Ages 0-21 years

You may not qualify if:

  • Patients who are uncomfortable with dogs
  • Patients who exhibits violent behavior
  • Animal Allergies
  • Patients are unable to work with a dog
  • Patients who exhibit severe cognitive delays

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hopsitals and Clinics of Minnesota

Saint Paul, Minnesota, 55102, United States

Location

MeSH Terms

Conditions

Learning DisabilitiesStrokeNeoplasmsMental DisordersFeeding and Eating Disorders

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Nicole Iammatteo, OT

    Children's Hospitals and Clinics of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2011

First Posted

September 28, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 14, 2014

Record last verified: 2014-02

Locations