UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044867 |
|---|---|
| Receipt number | R000051094 |
| Scientific Title | Investigation of muscle activity during sit-to-stand in patients with adult spinal deformity |
| Date of disclosure of the study information | 2021/07/15 |
| Last modified on | 2024/01/15 09:11:21 |
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Basic information
Public title
Investigation of muscle activity during sit-to-stand in patients with adult spinal deformity
Acronym
Investigation of muscle activity during sit-to-stand in patients with adult spinal deformity
Scientific Title
Investigation of muscle activity during sit-to-stand in patients with adult spinal deformity
Scientific Title:Acronym
Investigation of muscle activity during sit-to-stand in patients with adult spinal deformity
Region
| Japan |
Condition
Condition
Adult spinal deformity
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the characteristics of movement strategies by comparing the sit-to-stand movements of adult spinal deformity patients with healthy subjects.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ratio of muscle activity during sit-to-stand movement (% MVIC) to the maximum voluntary isometric contraction (MVIC) of the rectus femoris, biceps femoris, tibialis anterior, and soleus muscles.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A person who can perform sit-to-stand motion without the need for a support
Key exclusion criteria
Persons with a history of comorbidities with severe heart or lung disease
A person who cannot perform evaluation due to orthopedic disease
A person who develop neurological symptoms due to Parkinson's disease or other neuromuscular diseases
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Yamauchi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Rehabilitation
Zip code
431-3125
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture
TEL
053-435-2111
yamakatu@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yukako |
| Middle name | |
| Last name | Hayamizu |
Organization
Hamamatsu University School of Medicine
Division name
Department of Rehabilitation
Zip code
431-3125
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture
TEL
053-435-2111
Homepage URL
yukako.h0123@gmail.com
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee of Hamamatsu University School of Medicine
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture
Tel
053-435-2111
rinri@hama-med.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
| 2021 | Year | 07 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to investigate sit-to-stand movement strategies in adult spinal deformity patients and healthy subjects.
The primary outcome is % MVIC of the rectus femoris, biceps femoris, tibialis anterior, and soleus muscles during sit-to-stand motion.
The secondary outcomes are the range of motion of the hip joint, knee joint, and ankle joint during sit-to-stand movement, and time of sit-to-stand movement.
Management information
Registered date
| 2021 | Year | 07 | Month | 14 | Day |
Last modified on
| 2024 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051094
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
