UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053696 |
|---|---|
| Receipt number | R000061274 |
| Scientific Title | Immediate effects of two-legged squatting and one-legged squatting on finger-floor distance. |
| Date of disclosure of the study information | 2024/02/24 |
| Last modified on | 2024/02/24 12:20:41 |
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Basic information
Public title
Immediate effects of two-legged squatting and one-legged squatting on finger-floor distance.
Acronym
Immediate effects of two-legged squatting and one-legged squatting on finger-floor distance.
Scientific Title
Immediate effects of two-legged squatting and one-legged squatting on finger-floor distance.
Scientific Title:Acronym
Immediate effects of two-legged squatting and one-legged squatting on finger-floor distance.
Region
| Japan |
Condition
Condition
Healthy Subjects
Patients with orthopaedic diseases of the knee or ankle joints
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the immediate effects of squatting on one leg and squatting on both leg on finger-floor distance in healthy subjects or patients with orthopaedic diseases of the knee or ankle joints.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Finger-floor distance
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Stretch training (ST)
Sitting shallowly in a chair, one leg forward, trunk flexed in ankle dorsiflexion and knee extension, and continuous stretching of the posterior muscles of the lower limb (hamstrings) to the extent that pain does not occur. Perform each ST for 30 seconds on each leg.
Interventions/Control_2
Both-leg squat (Both-leg RT)
Legs shoulder-width apart, lower limbs held at an angle that allows holding for 5 s, with the flexed knee joint no further forward than the toes; 6 sets of 5s of holding and 5s of rest.
Interventions/Control_3
One-leg squat (one-leg RT)
One leg is held at an angle that allows the knee joint to be held for 5s without the knee joint being in front of the toes; 6 sets of 5s of holding and 5s of rest (3 sets per leg) are performed.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy subjects with no history of orthopaedic or neurological disease.
Patients with orthopaedic disease, a history of neurological disease and orthopaedic disease in the knee or ankle joint without load limitation.
Key exclusion criteria
Healthy subjects with a history of orthopaedic or neurological disease
Patients with a history of orthopaedic or neurological disease and orthopaedic disease of the knee or ankle joint with load limitation
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Shiratani |
Organization
Sonoda Second hospital
Division name
Department of Rehabiitaion
Zip code
121-0813
Address
4-2-17, Takenotsuka, Adachi-ku, Tokyo
TEL
03-3850-5723
prettyrokka@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Shiratani |
Organization
Sonoda Second Hospital
Division name
Department of Rehabiritation
Zip code
121-0813
Address
4-2-17, Takenotsuka, Adachi-ku, Tokyo
TEL
03-3850-5723
Homepage URL
prettyrokka@yahoo.co.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Without
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
Sonodakai Joint Replacement Center Hospital
Address
121-0064 1-21-10, Hokima, Adachi-ku, Tokyo
Tel
03-5831-1811
irb@sonodakai.or.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
| 2024 | Year | 02 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 24 | Day |
Last modified on
| 2024 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061274
