UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037506 |
|---|---|
| Receipt number | R000042746 |
| Scientific Title | motivational intervention for stroke rehabilitation: a feasibility study of dysphagia rehabilitation. |
| Date of disclosure of the study information | 2019/08/15 |
| Last modified on | 2021/02/17 11:34:30 |
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Basic information
Public title
motivational intervention for stroke rehabilitation: a feasibility study of dysphagia rehabilitation.
Acronym
motivational intervention for stroke rehabilitation: a feasibility study of dysphagia rehabilitation.
Scientific Title
motivational intervention for stroke rehabilitation: a feasibility study of dysphagia rehabilitation.
Scientific Title:Acronym
motivational intervention for stroke rehabilitation: a feasibility study of dysphagia rehabilitation.
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 dysphagia rehabilitation 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.Functional Independence Measure(FIM)
5.Self-rating Depression Scale(SDS)
6.Apathy Scale(AS)
7.Five scale rating on motivation for rehabilitation
8. The Mann Assessment of Swallowing ability(MASA)
9.Tongue pressure
10.Repetitive saliva swallowing test(RSST)
11.Seirei Dysphagia Questionnaire
12.FILS(Food Intake LEVEL Scale)
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Before the intervention, therapists will modify the content of his/her standard dysphagia rehabilitation based on the ARCS motivational model (Keller, 1984, 1987, 2009) in order to facilitate patients' motivation for dysphagia rehabilitation.
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 dysphagia rehabilitation according to the following ARCS models 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 40 minutes/days of the modified dysphagia rehabilitation for 4 weeks (5 days/week). The content of the revised dysphagia rehabilitation 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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Stroke patients with dysphagia
2.Stroke patients without cognitive dysfunction including aphasia and dementia (MMSE < 24)
3.Ability to understand an instruction of the experimental procedure in this study
4.Consent to participate in this study
Key exclusion criteria
1.Mental impairment leading to inability to cooperate
2.patients who are considered to be inappropriate to participate in the study
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Tanaka |
Organization
Hamamatsu University School of Medicine
Division name
Psychology
Zip code
4313192
Address
1-20-1 Handayama Higashi-ku, Hamamatsu-city, Japan
TEL
053-453-2111
tanakas@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Tanaka |
Organization
Hamamatsu University School of Medicine
Division name
Psychology
Zip code
4313192
Address
1-20-1 Handayama Higashi-ku, Hamamatsu-city, Japan
TEL
053-453-2111
Homepage URL
tanakas@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of education (Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hamamatsu City Rehabilitation Hospital, Shinshu University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Hamamatsu University School of Medicine
Address
1-20-1 Handayama Higashi-ku, Hamamatsu-city, Japan
Tel
053-453-2111
rinri@hama-med.ac.jp
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
浜松市リハビリテーション病院/ Hamamatsu City Rehabilitation Hospital
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 15 | 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 | 06 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
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
Management information
Registered date
| 2019 | Year | 07 | Month | 26 | Day |
Last modified on
| 2021 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042746
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