UMIN-CTR Clinical Trial

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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