UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030982 |
|---|---|
| Receipt number | R000035371 |
| Scientific Title | The effect of gait training combined with electrical stimulation in patients with femoral neck fracture |
| Date of disclosure of the study information | 2018/01/24 |
| Last modified on | 2019/02/23 10:11:08 |
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Basic information
Public title
The effect of gait training combined with electrical stimulation in patients with femoral neck fracture
Acronym
The effect of gait training combined with electrical stimulation
Scientific Title
The effect of gait training combined with electrical stimulation in patients with femoral neck fracture
Scientific Title:Acronym
The effect of gait training combined with electrical stimulation
Region
| Japan |
Condition
Condition
Femoral neck fracture
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of gait training combined with electrical stimulation on gluteus medius in patients with femoral neck fracture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
gait ability
muscle strength of hip abductor
Key secondary outcomes
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 | Other |
Interventions/Control_1
gait training combined with electrical stimulation
two weeks
20 minutes
Interventions/Control_2
gait training only
two weeks
20 minutes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients after initial femoral neck fracture
Patients who can walk with more than supervision
Key exclusion criteria
Mini Mental State Examination <21
Neurological disorders
Heart pacemaker
Severe heart disorders
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuya Takeda |
Organization
Kawamura Hospital
Division name
Department of Rehabilitation
Zip code
Address
84-1, Daihannya, Akutami, Gifu, Gifu
TEL
058-241-3311
kazuya2271@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Takeda |
Organization
Kawamura Hospital
Division name
Department of Rehabilitation
Zip code
Address
84-1, Daihannya, Akutami, Gifu, Gifu
TEL
058-241-3311
Homepage URL
kazuya2271@gmail.com
Sponsor or person
Institute
Kawamura Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2018 | Year | 01 | Month | 24 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 02 | 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
| 2018 | Year | 01 | Month | 24 | Day |
Last modified on
| 2019 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035371
