UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026808 |
|---|---|
| Receipt number | R000030779 |
| Scientific Title | Effects of belt electrode skeletal muscle electrical stimulation (B-SES) on disabled elderly patients with serious limitation of range of motion. |
| Date of disclosure of the study information | 2017/04/10 |
| Last modified on | 2017/03/31 18:55:13 |
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Basic information
Public title
Effects of belt electrode skeletal muscle electrical stimulation (B-SES) on disabled elderly patients with serious limitation of range of motion.
Acronym
Effects of B-SES on serious limitation of range of motion.
Scientific Title
Effects of belt electrode skeletal muscle electrical stimulation (B-SES) on disabled elderly patients with serious limitation of range of motion.
Scientific Title:Acronym
Effects of B-SES on serious limitation of range of motion.
Region
| Japan |
Condition
Condition
stroke, spinal cord injury, degenerative disease
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of B-SES on range of motion and muscle tone, and pain of disabled elderly patients with serious limitation of range of motion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Range of motion of lower limbs at baseline, and 1, 2, 3 months after strat of tretment
Key secondary outcomes
Muscle tone and Pain
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In addition to rehabilitation mainly consisted with ROMex and sitting or standing, B-SES is applied on bilateral lower limbs 3 times per week for 3 months.
Interventions/Control_2
Rehabilitation mainly consisted with ROMex and sitting or standing.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Bedridden disabled elderly patients
Key exclusion criteria
1) patients who cannot be applied electrical stimulation
2) patients who do not agree to this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Katoaka |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Locomotive Rehabilitation Science
Zip code
Address
1-7-1 Sakamoto Nagasaki, Japan
TEL
095-819-7919
kataoka-hide@kii.bbiq.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Katoaka |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Locomotive Rehabilitation Science
Zip code
Address
1-7-1 Sakamoto Nagasaki, Japan
TEL
095-819-7919
Homepage URL
kataoka-hide@kii.bbiq.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2017 | Year | 04 | Month | 10 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 10 | 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
| 2017 | Year | 03 | Month | 31 | Day |
Last modified on
| 2017 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030779
