UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029505 |
|---|---|
| Receipt number | R000031422 |
| Scientific Title | The effect of adjusting process of the challenge-skill balance for occupational therapy (ACS-OT) on the subjective quality of life in recovery rehabilitation unit: randomized controlled trial |
| Date of disclosure of the study information | 2017/10/11 |
| Last modified on | 2018/10/11 20:06:53 |
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Basic information
Public title
The effect of adjusting process of the challenge-skill balance for occupational therapy (ACS-OT) on the subjective quality of life in recovery rehabilitation unit: randomized controlled trial
Acronym
The effect of ACS-OT on the subjective quality of life in recovery rehabilitation unit
Scientific Title
The effect of adjusting process of the challenge-skill balance for occupational therapy (ACS-OT) on the subjective quality of life in recovery rehabilitation unit: randomized controlled trial
Scientific Title:Acronym
The effect of ACS-OT on the subjective quality of life in recovery rehabilitation unit
Region
| Japan |
Condition
Condition
Cerebrovascular disease and musculoskeletal disease clients who admitted the recovery rehabilitation unit
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether occupational therapy that includes adjusting process of the challenge-skill balance (ACS-OT) improves the subjective quality of life for clients in recovery rehabilitation unit
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ikigai-9 (Subjective quality of life)
Pre:Admission in the recovery rehabilitation unit
Post:Discharge
Follow up:3 months after discharge
Key secondary outcomes
EQ-5D-5L (Health-related quality of life)
The flow state scale for occupational tasks (Flow experience)
FIM (Activity of daily life)
Pre:Admission in the recovery rehabilitation unit
Post:Discharge
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A process of adjusting the balance between "challenge level" and "skill level" in occupational therapy is implemented to the experimental group.
Conventional occupational therapy is administered to the control group.
Interventions/Control_2
Occupational therapy (40-60 minutes per session) is held six times per week from Monday to Saturday in both groups.
The implementation period is from admission to discharge in the recovery rehabilitation unit.
Interventions/Control_3
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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Clients who admission in the recovery rehabilitation unit
Key exclusion criteria
MMSE score 23 or less
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ippei Yoshida |
Organization
Harue Hospital
Division name
Department of Rehabilitation
Zip code
Address
Haruecho Haribara 65-7 Sakai, Fukui, Japan
TEL
0776-51-0029
ippe.i.yoshi@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ippei Yoshida |
Organization
Harue Hospital
Division name
Department of Rehabilitation
Zip code
Address
65-7 Haribara, Harue-cho, Sakai-shi, Fukui, Japan
TEL
0776-51-0029
Homepage URL
ippe.i.yoshi@gmail.com
Sponsor or person
Institute
Tokyo metropolitan university
Graduate School of Human Health Sciences
Department of Occupational Therapy
Institute
Department
Personal name
Funding Source
Organization
Japanese Association of Occupational Therapists
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
Address
Tel
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
| 2017 | Year | 10 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 02 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 11 | Day |
Last modified on
| 2018 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031422
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
