UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054311 |
|---|---|
| Receipt number | R000062039 |
| Scientific Title | The Immediate Analgesic Effect and Impact on Gait Function of Transcutaneous Electrical Nerve Stimulation in Late-Stage Elderly Individuals with Knee Pain: Examination of Gait Function Using an IoT-Based Gait Analysis Device |
| Date of disclosure of the study information | 2024/05/02 |
| Last modified on | 2024/05/02 17:09:52 |
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Basic information
Public title
The Immediate Analgesic Effect and Impact on Gait Function of Transcutaneous Electrical Nerve Stimulation in Late-Stage Elderly Individuals with Knee Pain: Examination of Gait Function Using an IoT-Based Gait Analysis Device
Acronym
The Immediate Analgesic Effect and Impact on Gait Function of Transcutaneous Electrical Nerve Stimulation in Late-Stage Elderly Individuals with Knee Pain: Examination of Gait Function Using an IoT-Based Gait Analysis Device
Scientific Title
The Immediate Analgesic Effect and Impact on Gait Function of Transcutaneous Electrical Nerve Stimulation in Late-Stage Elderly Individuals with Knee Pain: Examination of Gait Function Using an IoT-Based Gait Analysis Device
Scientific Title:Acronym
The Immediate Analgesic Effect and Impact on Gait Function of Transcutaneous Electrical Nerve Stimulation in Late-Stage Elderly Individuals with Knee Pain: Examination of Gait Function Using an IoT-Based Gait Analysis Device
Region
| Japan |
Condition
Condition
Late-stage elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Immediate Analgesic Effect and Impact on Gait Function of Transcutaneous Electrical Nerve Stimulation in Late-Stage Elderly Individuals with Knee Pain
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait Function
Key secondary outcomes
Knee joint pain
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
30-60 minutes of transcutaneous electrical nerve stimulation on the knee
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
| 80 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Late-stage elderly with exercise habits
Key exclusion criteria
Contraindications for using low-frequency therapy devices (applicable to those using implanted medical electrical devices such as pacemakers, those with sensory impairments of the skin, those with abnormal skin conditions, those unable to communicate their intent, and those with severe peripheral circulatory disorders caused by conditions such as diabetes)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Taisuke |
| Middle name | |
| Last name | Ito |
Organization
Waseda Elderly Health Association Co., Ltd.
Division name
AYUMI EYE Department
Zip code
108-0074
Address
4-24-58 Takanawa, Minato-ku, Tokyo
TEL
+81-3-5447-5470
t_ito@waseda-e-life.co.jp
Public contact
Name of contact person
| 1st name | Taisuke |
| Middle name | |
| Last name | Ito |
Organization
Waseda Elderly Health Association Co., Ltd.
Division name
AYUMI EYE Department
Zip code
108-0074
Address
4-24-58 Takanawa, Minato-ku, Tokyo
TEL
+81-3-5447-5470
Homepage URL
t_ito@waseda-e-life.co.jp
Sponsor or person
Institute
Waseda Elderly Health Association Co., Ltd.
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
OMRON HEALTHCARE Co., Ltd.
Address
53 Ku-no-tsubo, Teradocho, Muko City, Kyoto
Tel
075-925-2000
nobuhiro.takakuwa@omron.com
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
株式会社早稲田エルダリーヘルス事業団
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | 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
32
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
| 2022 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 02 | Day |
Last modified on
| 2024 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062039
