![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000031619 |
Receipt No. | R000036092 |
Scientific Title | Exploratory study on the effect of voluntary hemiparetic upper limb training with video game for patients after stroke [Study by ABA design] |
Date of disclosure of the study information | 2018/03/06 |
Last modified on | 2018/03/06 |
Basic information | ||
Public title | Exploratory study on the effect of voluntary hemiparetic upper limb training with video game for patients after stroke [Study by ABA design] | |
Acronym | Exploratory study on the effect of voluntary hemiparetic upper limb training with video game for patients after stroke [Study by ABA design] | |
Scientific Title | Exploratory study on the effect of voluntary hemiparetic upper limb training with video game for patients after stroke [Study by ABA design] | |
Scientific Title:Acronym | Exploratory study on the effect of voluntary hemiparetic upper limb training with video game for patients after stroke [Study by ABA design] | |
Region |
|
Condition | |||
Condition | stroke | ||
Classification by specialty |
|
||
Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate the effectiveness of voluntary training with TV game for the upper paretic arm in patients with post-stroke hemiparesis |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Wolf moter function test(WMFT) |
Key secondary outcomes | Fugl-Meyer Assessment (FMA),
Action Research Arm Test (ARAT), Box and Block test(BBT) range of motion (ROM) |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Self control |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
|
|
Interventions/Control_1 | Voluntary upper limb training using video game machines | |
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | upper limb Br. S 3, 4 or 5
1) Upper paretic extremity after a new, single stroke 2) Unilateral cerebral hemisphere stoke 3) Within 6 months from the onset of stroke, 4) Brunnstrom stage in upper extremity scored 3, 4 or 5 5) Ability to sit on the chair for 15 min |
|||
Key exclusion criteria | 1)Patients who can not voluntarily train
2) Severe arm contracure 3) Severe arm pain 4) Anesthesia at arm 5) Aphasic, perceptual, apraxic, or cognitive deficits that would prevent adequate study participation 6) Inability to provide informed consent |
|||
Target sample size | 12 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Kagoshima University Graduate School of Medical and Dental Sciences | ||||||
Division name | Department of Rehabilitation Medicine and Physical Medicine | ||||||
Zip code | |||||||
Address | 8-35-1, Sakuragaoka, Kagoshima-city, Kagoshima | ||||||
TEL | 0992755339 | ||||||
m-k-t-u@m.kufm.kagoshima-u.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Kagoshima University Graduate School of Medical and Dental Sciences | ||||||
Division name | Department of Rehabilitation Medicine and Physical Medicine | ||||||
Zip code | |||||||
Address | 8-35-1, Sakuragaoka, Kagoshima-city, Kagoshima | ||||||
TEL | 0992755339 | ||||||
Homepage URL | |||||||
m-k-t-u@m.kufm.kagoshima-u.ac.jp |
Sponsor | |
Institute | Kagoshima University Hospital |
Institute | |
Department |
Funding Source | |
Organization | Kagoshima University |
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 | |
Address | |
Tel | |
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 |
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=R000036092 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |