UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042029 |
|---|---|
| Receipt number | R000047667 |
| Scientific Title | About squat movement of lower leg prosthesis-Focusing on muscle activity and the angle of each joint- |
| Date of disclosure of the study information | 2020/10/30 |
| Last modified on | 2020/10/06 16:16:55 |
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Basic information
Public title
About squat movement of lower leg prosthesis-Focusing on muscle activity and the angle of each joint-
Acronym
About squat movement of lower leg prosthesis-Focusing on muscle activity and the angle of each joint-
Scientific Title
About squat movement of lower leg prosthesis-Focusing on muscle activity and the angle of each joint-
Scientific Title:Acronym
About squat movement of lower leg prosthesis-Focusing on muscle activity and the angle of each joint-
Region
| Japan |
Condition
Condition
Lower leg amputation
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The maximum knee flexion angle when a lower leg prosthesis performs a squat motion with all soles touching the ground, the muscle activity of the quadriceps femoris at each angle, and helping to guide the muscle strengthening training of the lower limb amputated person. To do.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Age, gender, height, weight
Muscle activity: vastus medialis, rectus femoris, adductor muscles, gluteus maximus, biceps femoris
Maximum knee flexion angle
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
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
In all tasks, the starting position is to stand with both hands in front of the chest and both lower limbs open to the shoulder width.
Both the artificial limbs and non-artificial limbs shall perform squat movements with all soles in contact with the ground.
Knee flexion increases by ten twenty thirty and every ten, rests at each angle, and holds the squat position for five seconds.
The position of the center of gravity of the research subject is confirmed on the center of gravity sway meter monitor, and the measurer is instructed to maintain the median position in the front, back, left, and right.
The knee joint flexion angle is flexed every ten, and the measurement is terminated when the heel side of the prosthesis lower limb foot cannot touch the ground.
The muscle activity of the vastus medialis, rectus femoris and adductor muscles, gluteus maximus, and biceps femoris, which are the quadriceps femoris of the lower limb muscles on the wearing side during movement, was measured, and the knee joint on the same side. An angle meter will be installed in the area, and the effect of squats on each muscle and the maximum flexion angle of the knee joint will be examined.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects are men and women with lower leg prostheses who are 20 years old or older at the time of obtaining the consent form during the outpatient clinic for prosthetics and orthotics.
Those who have received sufficient explanation before participating in this research, and have obtained the voluntary consent of the research subject after sufficient understanding.
Key exclusion criteria
Those who have wounds or ulcers on the amputated or uncut leg and are currently being treated
Those who are allergic to alcohol and cannot treat their skin
Those who are judged by other researchers to be incompatible
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | yukihiko |
| Middle name | |
| Last name | kobayashi |
Organization
JR Tokyo General Hospital
Division name
Department of Rehabilitation
Zip code
151-8528
Address
2-1-3 Yoyogi, Shibuya-ku, Tokyo
TEL
03-3320-2210
06share10@jreast.co.jp
Public contact
Name of contact person
| 1st name | kyukihiko |
| Middle name | |
| Last name | kobayashi |
Organization
JR Tokyo General Hospital
Division name
Department of Rehabilitation
Zip code
151-8528
Address
2-1-3 Yoyogi, Shibuya-ku, Tokyo
TEL
03-3320-2210
Homepage URL
06share10@jreast.co.jp
Sponsor or person
Institute
JR Tokyo General Hospital
Institute
Department
Personal name
Funding Source
Organization
JR Tokyo General 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
JR Tokyo General Hospital
Address
2-1-3 Yoyogi, Shibuya-ku, Tokyo
Tel
03-3320-2210
06share10@jreast.co.jp
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 | 10 | Month | 30 | 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
| 2020 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | 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
| 2020 | Year | 10 | Month | 06 | Day |
Last modified on
| 2020 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047667
