UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041646 |
|---|---|
| Receipt number | R000047538 |
| Scientific Title | Clinometric gait analysis using smart insoles is significantly correlated with Fugl-Meyer Assessment results in patients with hemiplegia after stroke: Pilot study |
| Date of disclosure of the study information | 2020/09/02 |
| Last modified on | 2020/09/02 10:52:42 |
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Basic information
Public title
Clinometric gait analysis using smart insoles is significantly correlated with Fugl-Meyer Assessment results in patients with hemiplegia after stroke
Acronym
SI with FM
Scientific Title
Clinometric gait analysis using smart insoles is significantly correlated with Fugl-Meyer Assessment results in patients with hemiplegia after stroke: Pilot study
Scientific Title:Acronym
SI with FM
Region
| Asia(except Japan) |
Condition
Condition
Finished
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Providing an environment where stroke patients can easily measure walking ability is thought to help maintain chronic functions as well as acute rehabilitation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The smart insole gait parameter data were similar to those calculated manually.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
To confirm the reliability of gait analysis using smart insole technology, normal healthy controls wore insoles in their shoes during the timed up-and-go (TUG) test.
Interventions/Control_2
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
| 18 | years-old | < |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Ten healthy control subjects and ten patients with hemiplegia due to stroke participated
Key exclusion criteria
Patients were excluded if they had musculoskeletal disorders that could affect gait or diabetic complications that could cause peripheral neuropathy.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Myung-Jun |
| Middle name | |
| Last name | Shin |
Organization
Pusan National University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
49241
Address
179, Gudeok-Ro, Seo-Gu, Busan, Rep. of Korea
TEL
82-51-240-7485
drshinmj@pusan.ac.kr
Public contact
Name of contact person
| 1st name | Jong-Hwan |
| Middle name | |
| Last name | Park |
Organization
Pusan National University Hospital
Division name
Biomedical Research Institute
Zip code
49241
Address
179, Gudeok-Ro, Seo-Gu, Busan, Rep. of Korea
TEL
82-51-240-7071
Homepage URL
parkj@pusan.ac.kr
Sponsor or person
Institute
Pusan National University Hospital
Institute
Department
Personal name
Funding Source
Organization
Pusan National University Hospital
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
Pusan National University Hospital
Address
179, Gudeok-Ro, Seo-Gu, Busan, Rep. of Korea
Tel
82-51-240-7000
yalee@pnuh.co.kr
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 | 09 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2020 | 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 | 09 | Month | 02 | Day |
Last modified on
| 2020 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047538
