UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042548 |
|---|---|
| Receipt number | R000047567 |
| Scientific Title | Effectiveness of the Upper Limb Rehabilitation Support System Robot for Upper Limb Paralysis after Stroke |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2022/11/28 12:45:23 |
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Basic information
Public title
Effectiveness of the Upper Limb Rehabilitation Support System Robot for Upper Limb Paralysis after Stroke
Acronym
Effectiveness of the Upper Limb Rehabilitation Support System Robot for Upper Limb Paralysis after Stroke
Scientific Title
Effectiveness of the Upper Limb Rehabilitation Support System Robot for Upper Limb Paralysis after Stroke
Scientific Title:Acronym
Effectiveness of the Upper Limb Rehabilitation Support System Robot for Upper Limb Paralysis after Stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to improve upper limb function and increase the frequency of use of the paralyzed hand in daily life by providing stroke patients with upper limb paralysis with voluntary practice using the Upper Limb Rehabilitation Support System Robot.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer Assessment
Key secondary outcomes
Motor Activity Log
Simple Test for Evaluating Hand Function
Active ROM
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Voluntary practice using the Upper Limb Rehabilitation Support System Robot.
40 minutes a day, Seven days a week, Two weeks
Interventions/Control_2
Control
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Slight movement of the shoulders, elbows and fingers.
Br stage: 3or 4or 5
Key exclusion criteria
Serious comorbidities.
Significant pain in the shoulder or elbow.
Does not understand instructions.
Cannot sit in a chair for 40 minutes.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Noguchi |
Organization
Suzuka University of Medical Science
Division name
Department of Rehabilitation, Faculty of Health Science
Zip code
510-0293
Address
Kishioka 1001-1, Suzuka City, Mie
TEL
059-383-8991
reha.noguchi.ot@gmail.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Noguchi |
Organization
Suzuka University of Medical Science
Division name
Department of Rehabilitation, Faculty of Health Science
Zip code
510-0293
Address
Kishioka 1001-1, Suzuka City, Mie
TEL
059-383-8991
Homepage URL
reha.noguchi.ot@gmail.com
Sponsor or person
Institute
Suzuka University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Suzuka University of Medical Science
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suzuka University of Medical Science
Address
Kishioka 1001-1, Suzuka City, Mie
Tel
059-340-0550
isobe@suzuka-u.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
主体会病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | 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
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 25 | Day |
Last modified on
| 2022 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047567
