![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000040237 |
Receipt No. | R000045905 |
Scientific Title | Effects of repetitive facilitative exercise under continuous neuromuscular electrical stimulation for upper paretic extremity in acute phase stroke: A randomized controlled study |
Date of disclosure of the study information | 2020/04/27 |
Last modified on | 2020/04/25 |
Basic information | ||
Public title | Effects of repetitive facilitative exercise under continuous neuromuscular electrical stimulation for upper paretic extremity in acute phase stroke: A randomized controlled study | |
Acronym | Effects of repetitive facilitative exercise under electrical stimulation for upper paretic extremity | |
Scientific Title | Effects of repetitive facilitative exercise under continuous neuromuscular electrical stimulation for upper paretic extremity in acute phase stroke: A randomized controlled study | |
Scientific Title:Acronym | Effects of repetitive facilitative exercise under electrical stimulation for upper paretic extremity | |
Region |
|
Condition | ||
Condition | Stroke | |
Classification by specialty |
|
|
Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To examine repetitive facilitative exercise under continuous neuromuscular electrical stimulation for the upper paretic extremity in acute stroke patients. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Fugl-Meyer Assessment(FMA) |
Key secondary outcomes | Action research arm test(ARAT), active range of motion(AROM), Motor activity log(MAL), Modified Ashworth scale(MAS), Adverse event |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Cluster |
Blinding | Open -but assessor(s) are 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 | Repetitive facilitative exercise under continuous neuromuscular electrical stimulation(RFE under cNMES). Intervention on with RFE under cNMES is scheduled 30min/day, five times a week, for 1 weeks. | |
Interventions/Control_2 | Conventional rehabilitation therapy without neuromuscular electrical stimulation | |
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 | (1)patients who agree to participate in this study and provide their informed consent; (2)since after stroke within 1 weeks; (3)stroke type is only intracranial hemorrhage or ischemic stroke; (4)inpatients; (5)Brunnstrom Recovery stage is II, III, IV, V; (6)stable general condition | |||
Key exclusion criteria | (1)severe sensory disturbance or severe ataxia or severe higher brain dysfunction or severe dementia; (2)patients whose impairment severities changed during the study period; (3)contraindicated for the electrical stimulation (e.g. patients with a medical implant or implantable medical electrical equipment such as a cardiac pacemaker) | |||
Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Nippon Medical School Chiba Hokusoh Hospital | ||||||
Division name | Dept. of Rehabilitation | ||||||
Zip code | 270-1694 | ||||||
Address | 1715 Kamagari, Inzai, Chiba | ||||||
TEL | 0476-99-1111 | ||||||
t-hoei@nms.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Nippon Medical School Chiba Hokusoh Hospital | ||||||
Division name | Dept. of Rehabilitation | ||||||
Zip code | 270-1694 | ||||||
Address | 1715 Kamagari, Inzai, Chiba | ||||||
TEL | 0476-99-1111 | ||||||
Homepage URL | |||||||
t-hoei@nms.ac.jp |
Sponsor | |
Institute | Nippon Medical School Chiba Hokusoh Hospital |
Institute | |
Department |
Funding Source | |
Organization | Non |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Nippon Medical School Chiba Hokusoh Hospital |
Address | 1715 Kamagari, Inzai, Chiba |
Tel | 0476-99-1111 |
t-hoei@nms.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 |
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 | Preinitiation | ||||||
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=R000045905 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |