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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | stroke | |
Classification by specialty |
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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 |
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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. |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 12 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tokyo Bay Rehabilitation Hospital | ||||||
Division name | Department of Rehabilitation | ||||||
Zip code | 2750026 | ||||||
Address | 4-1-1 Yatsu, Narashino, Chiba | ||||||
TEL | 047-453-9010 | ||||||
OTR.taiki.yoshida@gmail.com |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
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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 |
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Last modified on |
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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 |