UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014444 |
|---|---|
| Receipt number | R000016802 |
| Scientific Title | Effects of corrections of misaligned musculoskeletal system on physical abilities and mental healthiness |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2014/07/01 14:18:07 |
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Basic information
Public title
Effects of corrections of misaligned musculoskeletal system on physical abilities and mental healthiness
Acronym
Effects of pelvic tilt correction by a Japanese stretching intervention on spinal curvatures during standing
Scientific Title
Effects of corrections of misaligned musculoskeletal system on physical abilities and mental healthiness
Scientific Title:Acronym
Effects of pelvic tilt correction by a Japanese stretching intervention on spinal curvatures during standing
Region
| Japan |
Condition
Condition
Backward pelvic tilt
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives were to scientifically investigate effects of skeletal system correction, specifically, pelvic position correction by alternative medicines, including oriental medicine, on physical abilities and mental healthiness and provide useful information to decrease medical cost.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Thoracic kyphosis angle
Lumbar lordosis angle
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention group: In order to resolve contractures in muscles and ligaments that control pelvic tilt, a certified Isogai dynamic therapist administered hip joint correction, pelvic tilt correction, lumbar alignment correction, and squat exercise stretch. The total duration of the four therapies was around 60 minutes, and the subjects received each intervention once.
Interventions/Control_2
Control group: Subjects performed 30-second standing and sitting hamstring stretches two times.
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
| 45 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy male adult
Key exclusion criteria
Male adults who have history of neurological or musculoskeletal disorders
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuji Suzuki |
Organization
Waseda University
Division name
Faculty of Human Sciences
Zip code
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192 Japan
TEL
04-2947-6705
shujiwhs@waseda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuji Suzuki |
Organization
Waseda University
Division name
Faculty of Human Sciences
Zip code
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192 Japan
TEL
04-2947-6705
Homepage URL
shujiwhs@waseda.jp
Sponsor or person
Institute
Waseda University
Faculty of Human Sciences
Suzuki Shuji Research Group
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 07 | Month | 01 | 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
After the interventions, the intervenion group showed an increase in lumbar lordosis angle but not in thoracic kyphosis angle. However, the control group showed no changes in lumbar lordosis and thoracic kyphosis angles.
The results of the intervention group will be presented in the International Society of Electrophysiology and Kinesiology 2014 (7/17/2014).
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
| 2013 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 06 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 01 | Day |
Last modified on
| 2014 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016802
