UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030958 |
|---|---|
| Receipt number | R000035341 |
| Scientific Title | The effect of task oriented training combined with electrical stimulation on hip abductor in patients with femoral neck fractrure. |
| Date of disclosure of the study information | 2018/01/23 |
| Last modified on | 2018/12/13 09:32:46 |
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Basic information
Public title
The effect of task oriented training combined with electrical stimulation on hip abductor in patients with femoral neck fractrure.
Acronym
The effect of task oriented training combined with electrical stimulation in patients with femoral neck fractrure.
Scientific Title
The effect of task oriented training combined with electrical stimulation on hip abductor in patients with femoral neck fractrure.
Scientific Title:Acronym
The effect of task oriented training combined with electrical stimulation in patients with femoral neck fractrure.
Region
| Japan |
Condition
Condition
Femoral neck fracture
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to preliminarily investigate the effect of task oriented training combined with electrical stimulation on hip abductor in patients with femoral neck fracture.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Force of hip abductor
walking ability
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
task oriented training combined with electrical stimulation
Interventions/Control_2
task oriented training
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. First fracture
2.Gait level is higher than T-cane gait under supervision.
3.Walking was independent before fracture.
Key exclusion criteria
1. Dementia (Mini-Mental State Examination (MMSE)< 24)
2. Neurological disorders
3. Heart pacemaker
4. Sensitive skin.
5. Inability to give informed consent form.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junji Nakamura |
Organization
Nishiyamato Rehabilitaiton Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
3-2-2, Sasayuridai, Kanmaki-cho, Kitakatsuragi-gun, Nara
TEL
0745-71-6688
n.junji.0923@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junji Nakamura |
Organization
Nishiyamato Rehabilitaiton Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
3-2-2, Sasayuridai, Kanmaki-cho, Kitakatsuragi-gun, Nara
TEL
0745-71-6688
Homepage URL
n.junji.0923@gmail.com
Sponsor or person
Institute
Nishiyamato Rehabilitaiton Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Electrophysical Agents in Physical Therapy
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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 | 23 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | 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
| 2018 | Year | 01 | Month | 23 | Day |
Last modified on
| 2018 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035341
