- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03910959
Therapeutic Effects of Animal-assisted Therapy for Patients in a Minimally Conscious State (MCS Therapy)
Therapeutic Effects of Animal-assisted Therapy for Patients in a Minimally Conscious State: a Randomized, Controlled Cross-over Study
The aim of this study is to investigate the effects of animal-assisted occupational therapy on patient's consciousness, measured via the achievement of predefined, patient-specific goals.
30 patients in a minimally conscious state will be included in this trial with randomized, controlled cross-over design. Patients will be randomized and allocated to either study arm 1 or 2 with an allocation ratio 1/1. In study arm 1, patients (N=15) receive three weeks of two AAT sessions per week followed by three weeks of two control sessions (TAU) per week. In study arm 2, patients (N=15) receive three weeks of two control sessions (TAU) per week followed by three weeks of two AAT sessions per week. Each session lasts 30 minutes. Goal attainment and secondary outcomes will be measured before the study start (pre-measurement, t0), at the end of the first 3 weeks therapy (post-measurement I, t1), at the start of the second 3 weeks (pre-measurement II, t2) as well as at the study end (post-measurement II, t3).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Early rehabilitation is crucial for patients in a minimally conscious state (MCS). The reorganization of neuronal structures and the recovery of cognitive processes as well as emotional and physical functions are most important. To reach these goals, animal-assisted therapy (AAT) is part of the therapeutic concept at REHAB Basel. Regarding the results of our previous studies at REHAB Basel, patients with brain-injuries can profit from animal-assisted therapy in terms of socioemotional skills and therapy motivation. Furthermore, patients with severe disorder of consciousness showed more behavioural reactions and arousal during AAT compared to standard therapy sessions. However, there is no research investigating if AAT can help to facilitate reaching rehabilitation goals in patients in a MCS and therefore advance neurorehabilitation. Hence, this study investigates if animal-assisted occupational therapy can facilitate attainment of therapeutic goals.
The main outcome is the amount of achievement of predefined, patient-specific therapeutic goals. This will be measured via the JFK Coma Remission Scale revised (CSR-R), the Basler Vegetative State Assessment (BAVESTA) and on a goal attainment scale in %, filled out by the therapist.
Secondary outcomes are:
- Behavioural reactions via behavioral video coding
- Heart rate, Heart rate variability (HR/HRV)
- Electrodermal activity (EDA) / Galvanic skin response (GSR)
The investigators will include 30 patients fulfilling the following inclusion criteria: Inpatients of REHAB Basel in a minimally conscious state (defined via the CRS-R according to the Aspen criteria); Minimum age of 18 years; Informed consent documented by signature by the patient's legal representative. The presence of any one of the following exclusion criteria will lead to exclusion of the participant: Medical contraindications for contact with animals such as allergy, phobia etc.); Enrollment of the investigator, his/her family members, employees and other dependent persons.
The study has a randomized, controlled cross-over design including 30 patients in a minimally conscious state. Patients will be randomized and allocated to either study arm 1 or 2 with an allocation ratio 1/1. In study arm 1, patients (N=15) receive three weeks of two AAT sessions per week followed by three weeks of two control sessions (TAU) per week. In study arm 2, patients (N=15) receive three weeks of two control sessions (TAU) per week followed by three weeks of two AAT sessions per week. Each session lasts 30 minutes. Before starting the study arm 1 or 2 therapists will define individual therapy goals for each patient.
Measurements will be taken before the study start (pre-measurement, t0), at the end of the first 3 weeks therapy (post-measurement I, t1), at the start of the second 3 weeks (pre-measurement II, t2) as well as at the study end (post-measurement II, t3).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Basel, Switzerland
- Recruiting
- REHAB Basel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Inpatients of REHAB Basel in a minimally conscious state
- Minimum age of 18 years
- Informed consent documented by signature by the patient's legal representative
Exclusion Criteria:
- Medical contraindications for contact with animals such as allergy, phobia etc.,
- Enrollment of the investigator, his/her family members, employees and other dependent persons.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Animal-assisted therapy
Patients receive three weeks of two AAT sessions, each lasting ca 30 minutes.
|
Therapy in the presence and with interaction with an animal.
Involved animals can be all species that live at REHAB Basel and are part of the AAT program.
All animals are trained for the specific service with vulnerable patients.
|
ACTIVE_COMPARATOR: treatment as usual
Patients receive three weeks of two control sessions, each lasting ca 30 minutes.
|
Parallelled conventional therapy sessions (treatment as usual)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount of goal achievement l: CSR-R
Time Frame: 3 weeks
|
The goal achievement will be assessed via the JFK Coma Remission Scale revised (CSR-R), with 6 subscales and a total score ranging from 0 to 23 with higher scores indicating better outcomes.
|
3 weeks
|
Amount of goal achievement II: BAVESTA
Time Frame: 3 weeks
|
The goal achievement will be assessed via the Basler Vegetative State Assessment.
The scale ranges from 0 to 5 with higher scores indicating better outcomes.
|
3 weeks
|
Amount of goal achievement III: VAS
Time Frame: 3 weeks
|
The goal achievement will also be assessed via a Visual Analogue Scale where a cross can be made on a line (measured in millimeters, ranging from 0 to 25) with higher values indicating better outcome.
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavioral reactions
Time Frame: 3 weeks
|
Behaviour of the patients will be coded in Noldus Observer according to a strict ethogram.
State behaviours will be reported in % (relative to the duration of a session) and count behaviours as total number of shown behaviours during a session.
|
3 weeks
|
Heart rate
Time Frame: 3 weeks
|
Heart rate will be measured in peats per minute using a Polar belt.
HR is reported in beat per minutes (bpm).
|
3 weeks
|
Heart rate variability
Time Frame: 3 weeks
|
Heart rate variability will be measured using a Polar belt.
HRV is reported as mean RR intervals.
The following HRV parameters will be calculated: time domain: the standard deviation of all normal-to-normal RR intervals (SDNN, ms) and root-mean square differences of successive RR intervals (RMSSD, ms); and frequency domain: relative power of the low frequency (LF) and high frequency (HF) band in normal units
|
3 weeks
|
Electrodermal activity (Galvanic Skin Response)
Time Frame: 3 weeks
|
Electrodermal activity will be measured using the EMBRACE wristband.
The outcome is reported in Microsiemens (sampling rate of 4Hz).
|
3 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-00350
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Minimally Conscious State
-
Hangzhou Normal UniversityCompletedPatients in Minimally Conscious State
-
University Hospital, Clermont-FerrandMedtronic; Fondation de l'AvenirCompletedChronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State)France
-
Hangzhou Normal UniversityCompletedPatients in Minimally Conscious State After a Severe Brain Injury
-
Casa Colina Hospital and Centers for HealthcareUCLA Department of Psychology; Tiny Blue Dot INC.CompletedTraumatic Brain Injury | Disorder of Consciousness | CVA (Cerebrovascular Accident) | Minimally Conscious State | Vegetative State | Thalamic Infarction | Coma; Prolonged | Minimally Conscious State Plus | Minimally Conscious State Minus | Anoxia, BrainUnited States
-
University of LiegeCompletedPatients in Minimally Conscious State After a Severe Brain Injury (e.g., Anoxia, Traumatic Brain Injury, Stroke)Belgium
-
Hangzhou Normal UniversityCompletedMinimally Conscious State | Vegetative State
-
IRCCS San Camillo, Venezia, ItalyCompletedMinimally Conscious State | Vegetative StateItaly
-
Hangzhou Normal UniversityCompleted
-
Jing WangCompletedMinimally Conscious State | Vegetative StateChina
-
Hangzhou Normal UniversityCompletedMinimally Conscious State | Vegetative StateChina
Clinical Trials on Animal-assisted therapy
-
Atlas UniversityNot yet recruitingDepression | Loneliness | Old Age; Debility | Nursing Home | Loss of Interest in Activities
-
Norwegian University of Life SciencesCompleted
-
Daniel Collado-MateoAsociación Dame La PataRecruitingWork Related Stress | Occupational GroupsSpain
-
Daniel Collado-MateoPurina España (Reg. Trademark of Nestle S.A.)Enrolling by invitationEating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/BulimiaSpain
-
Daniel Collado-MateoAsociación de Padres de Personas Con Autismo (APNA); Asociación Nuevo Horizonte and other collaboratorsEnrolling by invitationAutism Spectrum Disorder | AutismSpain
-
Uskudar UniversityNot yet recruiting
-
Chang Gung Memorial HospitalUnknownSchizophrenia | Animal-assisted TherapyTaiwan
-
Mayo ClinicCompletedHospitalized PatientsUnited States
-
Fundacio d'Investigacio en Atencio Primaria Jordi...CompletedChronic Pain
-
IRCCS Policlinico S. MatteoCompleted