UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035690 |
|---|---|
| Receipt number | R000040654 |
| Scientific Title | Kinaesthetic movement reproduction following a prior bout of isokinetic eccentric exercise with or without a below-knee compression garment in healthy adults |
| Date of disclosure of the study information | 2019/01/28 |
| Last modified on | 2021/02/09 12:17:53 |
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Basic information
Public title
Kinaesthetic movement reproduction following a prior bout of isokinetic eccentric exercise with or without a below-knee compression garment in healthy adults
Acronym
Below knee compression garment and joint position sensing after fatiguing exercise
Scientific Title
Kinaesthetic movement reproduction following a prior bout of isokinetic eccentric exercise with or without a below-knee compression garment in healthy adults
Scientific Title:Acronym
Below knee compression garment and joint position sensing after fatiguing exercise
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to investigate the effects of a below-knee CG on the fatiguing mechanism, induced by isokinetic training, on knee proprioception in healthy young adults. Specifically, we aim to determine how kinaesthetic movement reproduction is affected following a prior bout of isokinetic eccentric exercise on a dynamometer with or without a below-knee CG.
Basic objectives2
Others
Basic objectives -Others
Furthermore, we aim to investigate if changes in proprioception would still exit 24 hours and one week after the intervention.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Kinaesthetic movement reproduction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
below knee compression garment/fatiguing knee isokinetic exercise
Interventions/Control_2
no garment/fatiguing knee isokinetic exercise
Interventions/Control_3
below knee compression garment/no exercise
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) 20 year or older, younger than 40.
2) Right side dominant (both upper and lower limb)
Key exclusion criteria
1) current knee joing disorder
2) current skin infection
3) current motor dysfunction
4) past and current renal dysfunction
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Nagatomi |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8575
Address
Seiryo-cho 2-1, Aoba-ku, Sendai 980-8575
TEL
+81-22-717-8586
nagatomi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Nagatomi |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8575
Address
Seiryo-cho 2-1, Aoba-ku, Sendai 980-8575
TEL
+81-22-717-8586
Homepage URL
nagatomi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
Seiryo-cho 2-1, Aoba-ku, Sendai 980-8575
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.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
| 2019 | Year | 01 | Month | 28 | 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
24
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 10 | Month | 06 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 28 | Day |
Last modified on
| 2021 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040654
