UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058477 |
|---|---|
| Receipt number | R000066640 |
| Scientific Title | Randomized Controlled Trial Comparing the Effects of Cognitive Training, Physical Exercise, and Behavioral Therapy on Apathy in Post-Stroke Patients |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/10 16:44:34 |
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Basic information
Public title
Evaluation of the Effectiveness of Non-Pharmacological Interventions for Improving Apathy after Stroke
Acronym
Rehabilitation Trial for Post-Stroke Apathy
Scientific Title
Randomized Controlled Trial Comparing the Effects of Cognitive Training, Physical Exercise, and Behavioral Therapy on Apathy in Post-Stroke Patients
Scientific Title:Acronym
Apathy Post-stroke: Physical Exercise, cognitive training, And behavioral therapy for Life improvement
Region
| Japan |
Condition
Condition
Post-stroke apathy
Classification by specialty
| Neurology | Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare the effectiveness of three non-pharmacological interventions: cognitive training, physical exercise, and behavioral therapy for improving post-stroke apathy and to identify the most beneficial approach.
Basic objectives2
Others
Basic objectives -Others
This study aims to compare the effectiveness of three non-pharmacological interventions - cognitive training, physical exercise, and behavioral therapy - for improving post-stroke apathy. Additionally, it seeks to explore the relationships between the severity of apathy and cognitive, motor, emotional, and daily living functions, as well as lesion location in the brain.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Outcome measure: Subjective apathy assessment (Apathy Evaluation Scale: AES)
Assessment time points: Before intervention (Day 1) and after intervention (Day 14)
Key secondary outcomes
Assessment time points: Before intervention (Day 1) and after intervention (Day 14)
Outcome measures: Observer-rated apathy assessment (Apathy Evaluation Scale - Informant version - Japanese: AES-I-J), Cognitive function (Mini-Mental State Examination: MMSE), Motor function (Fugl-Meyer Motor Assessment), Emotional function (Hamilton Depression Rating Scale: Ham-D), Activities of daily living (Functional Independence Measure: FIM)
Assessment time point: Before intervention (Day 1)
Outcome measures: Brain imaging (lesion location assessed by MRI/CT), Demographic and medical data (age, sex, medical history, comorbidities, medication status)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Cognitive training will be provided for 40 minutes per day, 5 days per week, for 2 weeks (total 10 sessions). Training includes visual scanning tasks, verbal fluency tasks, and constructional tasks. The intervention will be administered by clinical rehabilitation staff.
Interventions/Control_2
Physical exercise will be conducted for 40 minutes per day, 5 days per week, for 2 weeks (total 10 sessions). The intervention includes sit-to-stand training, gait training, and muscle strengthening exercises. The intervention will be administered by clinical rehabilitation staff.
Interventions/Control_3
Behavioral therapy will be delivered using a behavioral economics-based approach. Participants set a behavioral goal to engage in 40 minutes of self-training per day, 5 days per week, for 2 weeks (total 10 sessions), along with a self-imposed behavioral restriction (e.g., limiting TV viewing). Commitment devices will be used to reinforce adherence.
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
| 18 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Ability to provide written informed consent, Aged between 18 and 79 years, Right-handed, MMSE score of 23 or higher, AES score of 37 or higher, Diagnosed with post-stroke apathy within 3 months after stroke onset
Key exclusion criteria
Patients with severe systemic diseases that hinder participation in rehabilitation, or with psychosis, depression, disturbance of consciousness, or hearing or visual impairments that interfere with assessment.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Fukunaga |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Speech-Language-Hearing Therapy
Zip code
701-0193
Address
288 Matsushima, Kurashiki, Okayama 701-0193, Japan
TEL
086-462-1111
sf@mw.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Matsuoka |
Organization
Graduate School, Kawasaki University of Medical Welfare
Division name
Graduate School of Health Sciences, Department of Sensory Rehabilitation
Zip code
701-0193
Address
288 Matsushima, Kurashiki, Okayama 701-0193, Japan
TEL
086-462-1111
Homepage URL
hhrgw67606@yahoo.co.jp
Sponsor or person
Institute
Kawasaki University of Medical Welfare
Institute
Department
Personal name
Funding Source
Organization
Kawasaki University of Medical Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Kawasaki Medical School Hospital
Address
577 Matsushima, Kurashiki, Okayama 710-0824, Japan
Tel
086-462-1111
kmsrec@med.kawasaki-m.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 | 08 | Month | 01 | 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 | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | 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 | 07 | Month | 15 | Day |
Last modified on
| 2025 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066640
