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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037324
Receipt No. R000042540
Scientific Title A motivational intervention for stroke rehabilitation: a feasibility study of occupational therapy.
Date of disclosure of the study information 2019/08/01
Last modified on 2019/07/10

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Basic information
Public title A motivational intervention for stroke rehabilitation: a feasibility study of occupational therapy.
Acronym A motivational intervention for stroke rehabilitation: a feasibility study of occupational therapy.
Scientific Title A motivational intervention for stroke rehabilitation: a feasibility study of occupational therapy.
Scientific Title:Acronym A motivational intervention for stroke rehabilitation: a feasibility study of occupational therapy.
Region
Japan

Condition
Condition stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to examine the feasibility of the ARCS model as a motivational intervention for occupational therapy in stroke patients.
Basic objectives2 Others
Basic objectives -Others Feasibility, safety, efficacy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.A Questionnaire on the Feasibility of this interventional protocol
2.Number of adverse event
3.Number of drop out
4.Motor Activity Log(MAL)
5.Functional Independence Measure(FIM)
6.Self-rating Depression Scale(SDS)
7.Apathy Scale(AS)
8.MOtivation for Rehabilitation Scale(MORE)
9.Five scale rating on motivation for rehabilitation
10.Total time of Voluntary participation on an arm reaching task
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Before the intervention, therapists will modify the content of his/her standard occupational therapy based on the ARCS motivational model (Keller, 1984, 1987, 2009) in order to facilitate patients' motivation for occupational therapy.
The ARCS model is a problem solving approach to design the motivational aspects of learning environments to stimulate motivation to learn.
Therapists will modify his/her occupational therapy according to the following ARCS model's four criteria. (1) ATTENTION. Does the therapy design to gain patients' attention? (e.g., use surprise or uncertainly to gain interest)? (2) RELEVANCE. Does the therapy design to establish relevance (e.g., provide information for future usefulness)? (3) CONFIDENCE. Does the therapy design for patients to have confidence? (e.g., control of difficulty); (4) SATISFACTION. Does the therapy design for patients to be satisfied or rewarded (e.g., praise)?
As a reference, a list of motivational strategies (see the below list in the section of "Other related information") will be presented to therapists. Therapist may utilize the list or may think of motivational strategies themselves.
Stroke patients will receive 60 minutes/ days of the modified occupational therapy for 4 weeks (5 days/week). The content of the revised occupational therapy will be reviewed and up-dated every week based on evaluation on patients' motivation.
Interventions/Control_2
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
40 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.Being between 30-180 days after first-ever stroke
2.Patients with unilateral upper limb motor paralysis (Fugl-Meyer Assessment<66)
3.Unilateral hemiparetic stroke without clear paralysis on the unaffected side
4.Ability to understand an instruction of the experimental procedure and execute motor and psychological tasks required in this study
5.Ability to remain seated independently
6.Consent to participate in this study
Key exclusion criteria 1. Limited range of motion, musculoskeletal impairments, and/or pain that affect motor tasks
2. Any other comorbid neurological disorder
3. Cognitive dysfunction including aphasia and dementia (MMSE < 24)
4. Mental impairment leading to inability to cooperate
5. patients who are considered to be inappropriate to participate in the study
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Taiki
Middle name
Last name Yoshida
Organization Tokyo Bay Rehabilitation Hospital
Division name Department of Rehabilitation
Zip code 2750026
Address 4-1-1 Yatsu, Narashino, Chiba
TEL 047-453-9010
Email OTR.taiki.yoshida@gmail.com

Public contact
Name of contact person
1st name Taiki
Middle name
Last name Yoshida
Organization Tokyo Bay Rehabilitation Hospital
Division name Department of Rehabilitation
Zip code 2750026
Address 4-1-1 Yatsu, Narashino-shi, Chiba
TEL 047-453-9010
Homepage URL
Email OTR.taiki.yoshida@gmail.com

Sponsor
Institute Tokyo Bay Rehabilitation Hospital
Institute
Department

Funding Source
Organization Self-funding
Ministry of education (Japan)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Hamamatsu University School of Medicine, Shinshu University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics committee of Tokyo Bay Rehabilitation Hospital
Address 4-1-1 Yatsu, Narashino-shi, Chiba
Tel 047-453-9000
Email shinsakai@wanreha.net

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 東京湾岸リハビリテーション病院(千葉県)
Tokyo Bay Rehabilitation Hospital(Chiba)

Other administrative information
Date of disclosure of the study information
2019 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 Enrolling by invitation
Date of protocol fixation
2019 Year 03 Month 12 Day
Date of IRB
2019 Year 03 Month 12 Day
Anticipated trial start date
2019 Year 07 Month 10 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information List of motivational strategies:
01) Control of task difficulty
02) Allowing patient to use a newly acquired skill
03) Applying patient's hobby and preference to exercise and practice task
04) Explaining the necessity of exercise and practice
05) Having a communication which make patient enjoy
06) Active listening
07) Providing opportunities of self-solving
08) Praise
09) Proposing conditions for exchange (e.g. promising to undertake patient's favorite practice after achieving his/her un-favorite practice)
10) Providing a suitable rehabilitation environment
11) Providing exercise and practice with game properties
12) Group rehabilitation
13) Providing medical information
14) Providing practice tasks relating to patient's experience and lifestyle
15) Goal-oriented practice
16) Providing variation of rehabilitation program to sustain interest
17) Recommending the family's presence with the patient during rehabilitation
18) Respect for self-determination
19) Sharing the criteria for evaluation
20) Setting goal
21) Specifying the amount of practice to be achieved
22) Using tools such as diary or graph allowing patient to confirm his/her progress

Management information
Registered date
2019 Year 07 Month 10 Day
Last modified on
2019 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042540

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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