![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000042548 |
Receipt No. | 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 | 2020/11/25 |
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 |
|
Condition | ||
Condition | stroke | |
Classification by specialty |
|
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
Institute | Suzuka University of Medical Science |
Institute | |
Department |
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 | 059-383-8991 |
reha.noguchi.ot@gmail.com |
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 |
|
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047567 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |