Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-03-27 @ 12:58 AM
Study NCT ID:
NCT02599766
Status:
COMPLETED
Last Update Posted:
2019-07-01
First Post:
2015-10-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Animal-assisted Therapy on Brain-injured Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056447', 'term': 'Animal Assisted Therapy'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'karin.hediger@unibas.ch', 'phone': '0041795197885', 'title': 'Dr. Karin Hediger', 'organization': 'Swiss TPH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, 6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Animal Assisted Therapy', 'description': '"Standard therapy" that is done in the presence and with integrating an animal.\n\nanimal assisted therapy: physiotherapy, speech therapy and occupational therapy in the presence of an animal', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Therapy', 'description': '"Standard therapy" without the presence of an animal.\n\nstandard therapy: standard physiotherapy, standard speech therapy and standard occupational therapy', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Social Functioning: Total Social Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Animal Assisted Therapy', 'description': '"Standard therapy" that is done in the presence and with integrating an animal.\n\nanimal assisted therapy: physiotherapy, speech therapy and occupational therapy in the presence of an animal'}, {'id': 'OG001', 'title': 'Standard Therapy', 'description': '"Standard therapy" without the presence of an animal.\n\nstandard therapy: standard physiotherapy, standard speech therapy and standard occupational therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '29.22', 'spread': '15.66', 'groupId': 'OG000'}, {'value': '8.68', 'spread': '8.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': '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.', 'unitOfMeasure': 'percentage of shown behavior', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Social Functioning: Verbal Communication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Animal Assisted Therapy', 'description': 'Animal assisted therapy (AAT): physiotherapy, speech therapy and occupational therapy in the presence of an animal. "Standard therapy" that is done in the presence and with integrating an animal.\n\nDuration of AAT: 6 weeks (12 AAT sessions) Frequency of administration: 2 sessions/week'}, {'id': 'OG001', 'title': 'Control Intervention', 'description': 'Control intervention: standard therapy (treatment as usual): physiotherapy, speech therapy and occupational therapy without an animal Duration of control therapy: 6 weeks (12 sessions) Frequency of administration: 2 sessions/week'}], 'classes': [{'categories': [{'measurements': [{'value': '25.4', 'spread': '19.44', 'groupId': 'OG000'}, {'value': '19.04', 'spread': '20.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentages of the defined verbal behaviors is collected and aggregated to one measure.', 'unitOfMeasure': 'percentage of verbal communication', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Social Functioning: Nonverbal Communication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Animal Assisted Therapy', 'description': 'Animal assisted therapy (AAT): physiotherapy, speech therapy and occupational therapy in the presence of an animal. "Standard therapy" that is done in the presence and with integrating an animal.\n\nDuration of AAT: 6 weeks (12 AAT sessions) Frequency of administration: 2 sessions/week'}, {'id': 'OG001', 'title': 'Control Intervention', 'description': 'Control intervention: standard therapy (treatment as usual): physiotherapy, speech therapy and occupational therapy without an animal Duration of control therapy: 6 weeks (12 sessions) Frequency of administration: 2 sessions/week'}], 'classes': [{'categories': [{'measurements': [{'value': '31.94', 'spread': '17.54', 'groupId': 'OG000'}, {'value': '5.26', 'spread': '7.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of the defined nonverbal behaviors is collected and aggregated to one measure.', 'unitOfMeasure': 'percentage of nonverbal communication', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Social Functioning: Physical Contact', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Animal Assisted Therapy', 'description': 'Animal assisted therapy (AAT): physiotherapy, speech therapy and occupational therapy in the presence of an animal. "Standard therapy" that is done in the presence and with integrating an animal.\n\nDuration of AAT: 6 weeks (12 AAT sessions) Frequency of administration: 2 sessions/week'}, {'id': 'OG001', 'title': 'Control Intervention', 'description': 'Control intervention: standard therapy (treatment as usual): physiotherapy, speech therapy and occupational therapy without an animal Duration of control therapy: 6 weeks (12 sessions) Frequency of administration: 2 sessions/week'}], 'classes': [{'categories': [{'measurements': [{'value': '18.32', 'spread': '18.50', 'groupId': 'OG000'}, {'value': '1.53', 'spread': '9.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of the defined physical contact is collected and aggregated to one measure.', 'unitOfMeasure': 'percentage of physical contact', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Social Functioning: Attention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Animal Assisted Therapy', 'description': 'Animal assisted therapy (AAT): physiotherapy, speech therapy and occupational therapy in the presence of an animal. "Standard therapy" that is done in the presence and with integrating an animal.\n\nDuration of AAT: 6 weeks (12 AAT sessions) Frequency of administration: 2 sessions/week'}, {'id': 'OG001', 'title': 'Control Intervention', 'description': 'Control intervention: standard therapy (treatment as usual): physiotherapy, speech therapy and occupational therapy without an animal Duration of control therapy: 6 weeks (12 sessions) Frequency of administration: 2 sessions/week'}], 'classes': [{'categories': [{'measurements': [{'value': '89.01', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '90.65', 'spread': '2.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of the defined attention behavior is collected and aggregated to one measure.', 'unitOfMeasure': 'percentage of attention', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Positive Emotional Display', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Animal Assisted Therapy', 'description': 'Animal assisted therapy (AAT): physiotherapy, speech therapy and occupational therapy in the presence of an animal. "Standard therapy" that is done in the presence and with integrating an animal.\n\nDuration of AAT: 6 weeks (12 AAT sessions) Frequency of administration: 2 sessions/week'}, {'id': 'OG001', 'title': 'Control Intervention', 'description': 'Control intervention: standard therapy (treatment as usual): physiotherapy, speech therapy and occupational therapy without an animal Duration of control therapy: 6 weeks (12 sessions) Frequency of administration: 2 sessions/week'}], 'classes': [{'categories': [{'measurements': [{'value': '6.95', 'spread': '7.47', 'groupId': 'OG000'}, {'value': '3.75', 'spread': '4.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Emotional display is assessed via video coding in Noldus Observer. Percentage of the defined behavior during the therapy sessions is collected and aggregated to one measure of positive emotion.', 'unitOfMeasure': 'percentage of positive emotion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Negative Emotional Display', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Animal Assisted Therapy', 'description': 'Animal assisted therapy (AAT): physiotherapy, speech therapy and occupational therapy in the presence of an animal. "Standard therapy" that is done in the presence and with integrating an animal.\n\nDuration of AAT: 6 weeks (12 AAT sessions) Frequency of administration: 2 sessions/week'}, {'id': 'OG001', 'title': 'Control Intervention', 'description': 'Control intervention: standard therapy (treatment as usual): physiotherapy, speech therapy and occupational therapy without an animal Duration of control therapy: 6 weeks (12 sessions) Frequency of administration: 2 sessions/week'}], 'classes': [{'categories': [{'measurements': [{'value': '0.31', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '2.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Emotional display is assessed via video coding in Noldus Observer. Percentage of the defined behavior during the therapy sessions is collected and aggregated to one measure of negative emotion.', 'unitOfMeasure': 'percentage of negative emotion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neutral Emotional Display', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Animal Assisted Therapy', 'description': 'Animal assisted therapy (AAT): physiotherapy, speech therapy and occupational therapy in the presence of an animal. "Standard therapy" that is done in the presence and with integrating an animal.\n\nDuration of AAT: 6 weeks (12 AAT sessions) Frequency of administration: 2 sessions/week'}, {'id': 'OG001', 'title': 'Control Intervention', 'description': 'Control intervention: standard therapy (treatment as usual): physiotherapy, speech therapy and occupational therapy without an animal Duration of control therapy: 6 weeks (12 sessions) Frequency of administration: 2 sessions/week'}], 'classes': [{'categories': [{'measurements': [{'value': '92.73', 'spread': '7.64', 'groupId': 'OG000'}, {'value': '94.20', 'spread': '6.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Emotional display is assessed via video coding in Noldus Observer. Percentage of the defined behavior during the therapy sessions is collected and aggregated to one measure of neutral emotion.', 'unitOfMeasure': 'percentage of neutral emotion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mood 1: Motivation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Animal Assisted Therapy', 'description': 'Animal assisted therapy (AAT): physiotherapy, speech therapy and occupational therapy in the presence of an animal. "Standard therapy" that is done in the presence and with integrating an animal.\n\nDuration of AAT: 6 weeks (12 AAT sessions) Frequency of administration: 2 sessions/week'}, {'id': 'OG001', 'title': 'Control Intervention', 'description': 'Control intervention: standard therapy (treatment as usual): physiotherapy, speech therapy and occupational therapy without an animal Duration of control therapy: 6 weeks (12 sessions) Frequency of administration: 2 sessions/week'}], 'classes': [{'categories': [{'measurements': [{'value': '138.80', 'spread': '27.13', 'groupId': 'OG000'}, {'value': '132.22', 'spread': '28.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Assessed via visual analogue scale as self-rating Scale ranging from 0 (not motivated) to 160 (highly motivated)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mood 2: Bipolar Mood Dimension (Good-bad)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Animal Assisted Therapy', 'description': 'Animal assisted therapy (AAT): physiotherapy, speech therapy and occupational therapy in the presence of an animal. "Standard therapy" that is done in the presence and with integrating an animal.\n\nDuration of AAT: 6 weeks (12 AAT sessions) Frequency of administration: 2 sessions/week'}, {'id': 'OG001', 'title': 'Control Intervention', 'description': 'Control intervention: standard therapy (treatment as usual): physiotherapy, speech therapy and occupational therapy without an animal Duration of control therapy: 6 weeks (12 sessions) Frequency of administration: 2 sessions/week'}], 'classes': [{'categories': [{'measurements': [{'value': '16.93', 'spread': '4.20', 'groupId': 'OG000'}, {'value': '16.12', 'spread': '4.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Assessed via the Mehrdimensionaler Befindlichkeitsfragebogen (MDBF) We analysed the bipolar mood dimension (good-bad) ranging from 4 (not at all good mood) to 20 (very good mood).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mood 3: Satisfaction Self-assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Animal Assisted Therapy', 'description': 'Animal assisted therapy (AAT): physiotherapy, speech therapy and occupational therapy in the presence of an animal. "Standard therapy" that is done in the presence and with integrating an animal.\n\nDuration of AAT: 6 weeks (12 AAT sessions) Frequency of administration: 2 sessions/week'}, {'id': 'OG001', 'title': 'Control Intervention', 'description': 'Control intervention: standard therapy (treatment as usual): physiotherapy, speech therapy and occupational therapy without an animal Duration of control therapy: 6 weeks (12 sessions) Frequency of administration: 2 sessions/week'}], 'classes': [{'categories': [{'measurements': [{'value': '129.81', 'spread': '23.80', 'groupId': 'OG000'}, {'value': '124.54', 'spread': '37.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Assessed via visual analogue scale as rating by the therapist Satisfaction during the therapy sessions was assessed by the patient themselves using a VAS ranging from 0 (unsatisfied) to 160 (satisfied).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mood 4: Satisfaction Therapist Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Animal Assisted Therapy', 'description': 'Animal assisted therapy (AAT): physiotherapy, speech therapy and occupational therapy in the presence of an animal. "Standard therapy" that is done in the presence and with integrating an animal.\n\nDuration of AAT: 6 weeks (12 AAT sessions) Frequency of administration: 2 sessions/week'}, {'id': 'OG001', 'title': 'Control Intervention', 'description': 'Control intervention: standard therapy (treatment as usual): physiotherapy, speech therapy and occupational therapy without an animal Duration of control therapy: 6 weeks (12 sessions) Frequency of administration: 2 sessions/week'}], 'classes': [{'categories': [{'measurements': [{'value': '137.31', 'spread': '23.80', 'groupId': 'OG000'}, {'value': '128.14', 'spread': '27.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Satisfaction during the therapy sessions was assessed by the therapist using a VAS ranging from 0 (unsatisfied) to 160 (satisfied).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Animal Assisted Therapy', 'description': 'Animal assisted therapy (AAT): physiotherapy, speech therapy and occupational therapy in the presence of an animal. "Standard therapy" that is done in the presence and with integrating an animal.\n\nDuration of AAT: 6 weeks (12 AAT sessions) Frequency of administration: 2 sessions/week'}, {'id': 'OG001', 'title': 'Control Intervention', 'description': 'Control intervention: standard therapy (treatment as usual): physiotherapy, speech therapy and occupational therapy without an animal Duration of control therapy: 6 weeks (12 sessions) Frequency of administration: 2 sessions/week'}], 'classes': [{'categories': [{'measurements': [{'value': '85.23', 'spread': '13.03', 'groupId': 'OG000'}, {'value': '83.41', 'spread': '14.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Assessed via EKG (Polar) during the sessions and measured in beat/min.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Motor Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Animal Assisted Therapy', 'description': 'Animal assisted therapy (AAT): physiotherapy, speech therapy and occupational therapy in the presence of an animal. "Standard therapy" that is done in the presence and with integrating an animal.\n\nDuration of AAT: 6 weeks (12 AAT sessions) Frequency of administration: 2 sessions/week'}, {'id': 'OG001', 'title': 'Control Intervention', 'description': 'Control intervention: standard therapy (treatment as usual): physiotherapy, speech therapy and occupational therapy without an animal Duration of control therapy: 6 weeks (12 sessions) Frequency of administration: 2 sessions/week'}], 'classes': [{'categories': [{'measurements': [{'value': '90.93', 'spread': '55.45', 'groupId': 'OG000'}, {'value': '75.88', 'spread': '60.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Assessed via actimeter at the patients wrist during sessions, measuring acceleration of the hand. It records data in 15-s epochs for maximum sensitivity. Data were calculated to yield average activity Counts per minute.', 'unitOfMeasure': 'counts per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AAT and Control Intervention', 'description': 'Animal assisted therapy (AAT): physiotherapy, speech therapy and occupational therapy in the presence of an animal. "Standard therapy" that is done in the presence and with integrating an animal.\n\nDuration of AAT: 6 weeks (12 AAT sessions) Frequency of administration: 2 sessions/week\n\nControl intervention: standard therapy (treatment as usual): physiotherapy, speech therapy and occupational therapy without an animal Duration of control therapy: 6 weeks (12 sessions) Frequency of administration: 2 sessions/week'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AAT and Control Intervention', 'description': 'Animal assisted therapy (AAT): physiotherapy, speech therapy and occupational therapy in the presence of an animal\n\nControl intervention: standard physiotherapy, speech therapy and occupational therapy'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.84', 'spread': '14.40', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Switzerland', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'FIM (Functional Independence Measure)', 'classes': [{'categories': [{'measurements': [{'value': '68.67', 'spread': '26.08', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The FIM includes 18 items, each with a maximum score of 7 and a minimum score of 1. Possible scores range from 18 to 126. Each level of scoring is defined with higher scores refering to better outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-04', 'studyFirstSubmitDate': '2015-10-29', 'resultsFirstSubmitDate': '2018-04-20', 'studyFirstSubmitQcDate': '2015-11-06', 'lastUpdatePostDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-04', 'studyFirstPostDateStruct': {'date': '2015-11-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Social Functioning: Total Social Behavior', 'timeFrame': '6 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Social Functioning: Verbal Communication', 'timeFrame': '6 weeks', 'description': 'Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentages of the defined verbal behaviors is collected and aggregated to one measure.'}, {'measure': 'Social Functioning: Nonverbal Communication', 'timeFrame': '6 weeks', 'description': 'Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of the defined nonverbal behaviors is collected and aggregated to one measure.'}, {'measure': 'Social Functioning: Physical Contact', 'timeFrame': '6 weeks', 'description': 'Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of the defined physical contact is collected and aggregated to one measure.'}, {'measure': 'Social Functioning: Attention', 'timeFrame': '6 weeks', 'description': 'Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of the defined attention behavior is collected and aggregated to one measure.'}, {'measure': 'Positive Emotional Display', 'timeFrame': '6 weeks', 'description': 'Emotional display is assessed via video coding in Noldus Observer. Percentage of the defined behavior during the therapy sessions is collected and aggregated to one measure of positive emotion.'}, {'measure': 'Negative Emotional Display', 'timeFrame': '6 weeks', 'description': 'Emotional display is assessed via video coding in Noldus Observer. Percentage of the defined behavior during the therapy sessions is collected and aggregated to one measure of negative emotion.'}, {'measure': 'Neutral Emotional Display', 'timeFrame': '6 weeks', 'description': 'Emotional display is assessed via video coding in Noldus Observer. Percentage of the defined behavior during the therapy sessions is collected and aggregated to one measure of neutral emotion.'}, {'measure': 'Mood 1: Motivation', 'timeFrame': '6 weeks', 'description': 'Assessed via visual analogue scale as self-rating Scale ranging from 0 (not motivated) to 160 (highly motivated)'}, {'measure': 'Mood 2: Bipolar Mood Dimension (Good-bad)', 'timeFrame': '6 weeks', 'description': 'Assessed via the Mehrdimensionaler Befindlichkeitsfragebogen (MDBF) We analysed the bipolar mood dimension (good-bad) ranging from 4 (not at all good mood) to 20 (very good mood).'}, {'measure': 'Mood 3: Satisfaction Self-assessment', 'timeFrame': '6 weeks', 'description': 'Assessed via visual analogue scale as rating by the therapist Satisfaction during the therapy sessions was assessed by the patient themselves using a VAS ranging from 0 (unsatisfied) to 160 (satisfied).'}, {'measure': 'Mood 4: Satisfaction Therapist Rating', 'timeFrame': '6 weeks', 'description': 'Satisfaction during the therapy sessions was assessed by the therapist using a VAS ranging from 0 (unsatisfied) to 160 (satisfied).'}, {'measure': 'Heart Rate', 'timeFrame': '6 weeks', 'description': 'Assessed via EKG (Polar) during the sessions and measured in beat/min.'}, {'measure': 'Motor Activity', 'timeFrame': '6 weeks', 'description': 'Assessed via actimeter at the patients wrist during sessions, measuring acceleration of the hand. It records data in 15-s epochs for maximum sensitivity. Data were calculated to yield average activity Counts per minute.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['animal assisted intervention, brain injury, rehabilitation'], 'conditions': ['Impaired Social Functioning']}, 'referencesModule': {'references': [{'pmid': '29035068', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This 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.\n\nOver a period of six 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 24 therapy sessions (12 experimental, 12 control) for each patient.\n\nEach therapy session lasts 30 minutes with an additional 5 minutes before and 10 minutes after the session for filling in the questionnaires.\n\nThe study takes place at REHAB Basel. Animal-assisted therapies will be held at the "Therapie-Tiergarten" at REHAB Basel in the presence of one or more animals that will be selected by the therapist and the patient together and with which the patient has a relationship.\n\nPatients who are willing to join the study will be selected and allocated randomly to start with either the experimental or the control condition.\n\nParticipation in the study will be cancelled if a patient wishes to do so or if they choose to withdraw from the animal-assisted therapy program. Other criteria for withdrawal are if the patient is harmed by an animal or if the animals are abused by the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient at REHAB Basel\n* brain-injury\n* willing to participate in animal-assisted therapies\n* physical and psychological resilience and ability to go/be transported outside to the "Therapie-Tiergarten"\n* ability to get in contact with the animal autonomously\n\nExclusion Criteria:\n\n* medical contraindications:allergies, phobias, etc.\n* no willingness to participate in animal-assisted therapies\n* patient might present a danger to the animals (aggressive behaviour)\n* patient\'s medication changes radically during the time of data collection'}, 'identificationModule': {'nctId': 'NCT02599766', 'briefTitle': 'Effects of Animal-assisted Therapy on Brain-injured Patients', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Tropical & Public Health Institute'}, 'officialTitle': 'Short-term Effects of Animal-assisted Therapy on the Rehabilitation Process of Brain-injured Patients at REHAB Basel', 'orgStudyIdInfo': {'id': 'Ref.Nr.EK:296/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'animal assisted therapy', 'description': '"Standard therapy" that is done in the presence and with integrating an animal.', 'interventionNames': ['Other: animal assisted therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard therapy', 'description': '"Standard therapy" without the presence of an animal.', 'interventionNames': ['Other: standard therapy']}], 'interventions': [{'name': 'animal assisted therapy', 'type': 'OTHER', 'description': 'physiotherapy, speech therapy and occupational therapy in the presence of an animal', 'armGroupLabels': ['animal assisted therapy']}, {'name': 'standard therapy', 'type': 'OTHER', 'description': 'standard physiotherapy, standard speech therapy and standard occupational therapy', 'armGroupLabels': ['standard therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4012', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'REHAB Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Margret Hund-Georgiadis, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rehab Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Tropical & Public Health Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute for Interdisciplinary Research on the Human-Pet Relationship', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. phil.', 'investigatorFullName': 'Karin Hediger', 'investigatorAffiliation': 'Swiss Tropical & Public Health Institute'}}}}