UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057830 |
|---|---|
| Receipt number | R000066003 |
| Scientific Title | The clinical efficacy of a new Rehabilitation Method using Animal Assisted Therapy |
| Date of disclosure of the study information | 2025/05/11 |
| Last modified on | 2025/05/11 12:59:29 |
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Basic information
Public title
A new Rehab Method using Animal Therapy
Acronym
Animal Therapy and Rehab
Scientific Title
The clinical efficacy of a new Rehabilitation Method using Animal Assisted Therapy
Scientific Title:Acronym
Animal Therapy and Rehabilitation
Region
| Japan |
Condition
Condition
Group A: Children thru Adolescent (Age 13 thru 18) with Developmental Disorders (LD, ADHD, Autism etc). Group B: Geriatric Adults (Age 65 thru 100) with Dementia. Control Group (vs Groups A,B): Adolescent thru Geriatric age, basically those who do not meet criterias A and B, who are capable of leading a normal active daily life compared with the same Groups A, B.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By utilizing the characteristics and efficacy indicated by previous studies on animal therapy, we will add our rehabilitation methods (such as exercise therapy by physical therapists and psychological interventions by occupational therapists) and measure various data related to physical and mental functions during the treatment process for children and the elderly. We intend to quantitatively analyze the effectiveness of combining animal therapy with standard rehabilitation methods such as home exercise therapy to statistically determine if significant evidence can be obtained.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To see if mental evaluated items; 'motivation' and 'spontaneity' improve as main evaluation outcome(s).
Key secondary outcomes
To see if physical parameters, cognitive function, and autonomic nervous system parameters (using HRV data) improve as secondary evaluation outcome(s).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Pet dog for 5 minutes, walk dog for with double lead for 5 minutes, and conduct a reading program (reading picture books to the dog) for 5 minutes, repeating this every two weeks, for a total of 6 times.
Interventions/Control_2
Same protocol as Control 1; Pet dog for 5 minutes, walk dog for with double lead for 5 minutes, and conduct a reading program (reading picture books to the dog) for 5 minutes, repeating this every two weeks, for a total of 6 times.
Interventions/Control_3
Same protocol as Control 1; Pet dog for 5 minutes, walk dog for with double lead for 5 minutes, and conduct a reading program (reading picture books to the dog) for 5 minutes, repeating this every two weeks, for a total of 6 times.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 13 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Group A: Using the Ministry of Education, Culture, Sports, Science and Technology standards, minors (aged 13 to under 18) who face barriers such as Learning Disorder (LD), Attention Deficit/Hyperactivity Disorder (ADHD), high-functioning autism, developmental coordination disorder, social withdrawal, and long-term absenteeism, who find it difficult to lead a typical social life.
Group B: Elderly individuals (aged 65 to under 100) who have some form of dementia (including multi-infarct dementia, Alzheimer's type dementia, and Lewy body dementia) or mental and neurological symptoms such as geriatric depression, making it difficult for them to lead a normal social life.
Control group ("control" vs. groups A and B): Patients without serious cardiopulmonary dysfunction necessitating drug therapy or neuropsychiatric disorders,who are deemed appropriate by the attending physician (aged 18 to under 100). This group can be compared to groups A and B and is characterized as being able to "live a social life."
Key exclusion criteria
1)Patients with cognitive dysfunction due to high-order brain function disorders caused by traffic trauma, brain tumors, or metastasis of cancer to the brain.
2)Patients with a clear history of dog allergies or phobias who cannot withstand treatment involving contact with dogs for about 30 minutes.
3)Patients who have participated in similar treatment studies within the past 12 weeks.
4)Patients who have previously exhibited inhumane violent behavior towards animals.
5)Other patients deemed inappropriate for participation by the attending physician.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Ou |
| Middle name | |
| Last name | Oikawa |
Organization
Asahikawa Medical University
Division name
Department of Rehabilitation Medicine
Zip code
078-8510
Address
1-1, 1-chome, Midorigaoka Higashi 2-jo, Asahikawa City, Hokkaido
TEL
0166-68-2873
oikawa@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Ou |
| Middle name | |
| Last name | Oikawa |
Organization
Asahikawa Medical University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
078-8510
Address
1-1, 1-chome, Midorigaoka Higashi 2-jo, Asahikawa City, Hokkaido
TEL
0166-68-2873
Homepage URL
oikawa@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Midorinomori Animal Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University Research Ethics Committee
Address
1-1, 1-chome, Midorigaoka Higashi 2-jo, Asahikawa City
Tel
0166682297
rs-kp.g@asahikawa-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 11 | Day |
Last modified on
| 2025 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066003
