UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040237 |
|---|---|
| Receipt number | 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 22:43:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
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
| Maneuver |
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
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
| 1st name | Takashi |
| Middle name | |
| Last name | Hoei |
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
| 1st name | Takashi |
| Middle name | |
| Last name | Hoei |
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 or person
Institute
Nippon Medical School Chiba Hokusoh Hospital
Institute
Department
Personal name
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
| 2020 | Year | 04 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | 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 | 04 | Month | 25 | Day |
Last modified on
| 2020 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045905
