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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029505
Receipt No. 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

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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
Email 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
Email ippe.i.yoshi@gmail.com

Sponsor
Institute Tokyo metropolitan university
Graduate School of Human Health Sciences
Department of Occupational Therapy
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031422

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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