UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050514 |
|---|---|
| Receipt number | R000053377 |
| Scientific Title | Effects of different iliopsoas stretching on iliopsoas / spine alignment-randomized crossover study- |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2023/03/04 17:19:29 |
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Basic information
Public title
Effects of different iliopsoas stretching on the iliopsoas and spine
Acronym
Effects of different iliopsoas stretching on the iliopsoas and spine
Scientific Title
Effects of different iliopsoas stretching on iliopsoas / spine alignment-randomized crossover study-
Scientific Title:Acronym
Effects of different iliopsoas stretching on iliopsoas / spine alignment-randomized crossover study-
Region
| Japan |
Condition
Condition
hearth
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to clarify the effect of stretching on lumbar lordosis on hip flexor muscle group shortening
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Lumbar lordosis angle, pelvic tilt angle
Key secondary outcomes
Range of motion of the lumbar spine and pelvis, strength of hip flexion
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Static stretching
Interventions/Control_2
Hold Relax-PNF stretching
Interventions/Control_3
dynamic stretching
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
| 18 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy university student
Key exclusion criteria
Persons with lower limb injuries or pain, orthopedics, neurological, cardiovascular abnormalities, or a history of surgery
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | kazuo |
| Middle name | |
| Last name | kurosawa |
Organization
international university of hearth and welfare
Division name
odawara campus
Zip code
250-8588
Address
shiroyama odawara-city kanagawa prefecture1-2-25
TEL
090-8686-6334
kkuro@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | kazuo |
| Middle name | |
| Last name | kurosawa |
Organization
international university of hearth and welfare
Division name
odawara campus
Zip code
250-8588
Address
shiroyama odawara-city kanagawa prefecture japan 1-2-25
TEL
090-8686-6334
Homepage URL
https://www.iuhw.ac.jp/daigakuin/
kkuro@iuhw.ac.jp
Sponsor or person
Institute
Ministry of education
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
international university of hearth and welfare
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
international university of hearth and welfare
Address
4-1-26 Akasaka, Minato-ku, Tokyo,japan
Tel
03-5574-3900
akasaka-nyushi@iuhw.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
国際医療福祉大学小田原保健医療学部（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 31 | 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
18
Results
It was found that the range of motion of the lumbar spine increased to some extent regardless of the stretching method.HR-PNF showed an increase in T12 and a decrease in pelvic tilt angle. A decrease in T12 was observed in DS.
Results date posted
| 2023 | Year | 01 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
18 young healthy subjects(9 males and 9 females)
Participant flow
18 young healthy subjects were randomized and divided into 6 groups,and Three sets of 20-seconds Static Stretching,Hold Relax - PNF Stretching, and Dynamic Stretching was performed on Hip Flexor Muscles,12th Thoracic
Angle,1th Sacrum Angle, the Angle of Lumbar Lordosis, Lumbar Flexion, Lumbar Extension, Lumbar Lateral Bending, The Rotation of Thoracic and Lumbar Spines, Pelvic Tilting Angle, and pelvic tilt angle were measured before, immediately after, 30, 60, and 90 minutes after stretching.After the measurement immediately after stretching was completed, the iliopsoas muscle was kept in the bed in neutral position for a period of 30 minutes between measurements.
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 07 | Day |
Last modified on
| 2023 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053377
