UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020569 |
|---|---|
| Receipt number | R000023749 |
| Scientific Title | The effect of functional electrical stimulation (WalkAide®)in the patients with brain injury: A pilot trial |
| Date of disclosure of the study information | 2016/01/14 |
| Last modified on | 2016/01/30 22:42:32 |
* 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
The effect of functional electrical stimulation (WalkAide®)in the patients with brain injury: A pilot trial
Acronym
The effect of functional electrical stimulation
Scientific Title
The effect of functional electrical stimulation (WalkAide®)in the patients with brain injury: A pilot trial
Scientific Title:Acronym
The effect of functional electrical stimulation
Region
| Japan |
Condition
Condition
Hemiplegic patients with brain injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of functional electrical stimulation for gait exercise
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
10m-walk test at baseline and after 8-week intervention
Key secondary outcomes
Fugl-Meyer Assessment, Bnnstrom stage, dified Ashworth Scale, 6 minute walk test, Functional independence Measure: FIM, Frenchay Activities Index, Stroke impact Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Device,equipment |
Interventions/Control_1
Gait training with functionalelectrical stimulation (FES). Intervention with FES is scheduled 40min/day, five times a week, for 8 weeks.
Interventions/Control_2
Gait training with ankle-foot orthosis (AFO)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
hemiplegic patients with brain injury; stable condition; Brunnstrom recovery of lower limb >III; informed consent
Key exclusion criteria
severe higher brain dysfunction; severe dementia; poor consciousness; previous gait disturbance; severe sensory disturbance; skin disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuji Matsumoto |
Organization
Kagoshima University
Division name
Dept. of Rehabilitation
Zip code
Address
3930-7 Takachiho, Makizono-cho, Kirishima City
TEL
0995-78-2538
shushu@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuji Matsumoto |
Organization
Kagoshima University
Division name
Dept. of Rehabilitation
Zip code
Address
3930-7 Takachiho, Makizono-cho, Kirishima City
TEL
0995-78-2538
Homepage URL
shushu@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
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
| 2016 | Year | 01 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
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
| 2016 | Year | 01 | Month | 14 | Day |
Last modified on
| 2016 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023749
