UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037676 |
|---|---|
| Receipt number | R000042511 |
| Scientific Title | Kinematics and kinematic analysis during activity before and after anterior cruciate ligament reconstruction |
| Date of disclosure of the study information | 2019/08/13 |
| Last modified on | 2022/02/14 16:00:57 |
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Basic information
Public title
Kinematics and kinematic analysis during activity before and after anterior cruciate ligament reconstruction
Acronym
Kinematics and kinematic analysis during activity before and after anterior cruciate ligament reconstruction
Scientific Title
Kinematics and kinematic analysis during activity before and after anterior cruciate ligament reconstruction
Scientific Title:Acronym
Kinematics and kinematic analysis during activity before and after anterior cruciate ligament reconstruction
Region
| Japan |
Condition
Condition
Anterior cruciate ligament injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the characteristics in the knee movement during activity before and after anterior cruciate ligament reconstruction
Basic objectives2
Others
Basic objectives -Others
To investigate the usability of evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The characteristics in the knee movement during single-leg squatting before anterior cruciate ligament reconstruction (knee angles and variability of angles)
Key secondary outcomes
The characteristics in the knee movement during jump landing one year after anterior cruciate ligament reconstruction (knee angles and variability of angles)
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
| 14 | years-old | <= |
Age-upper limit
| 35 | years-old | > |
Gender
Male and Female
Key inclusion criteria
anterior cruciate ligament-injured patients
Inclusion criteria consisted of participants being able to walk unaided, perform their normal activities of daily living without assistance, having a positive Lachman Test.
patients with anterior cruciate ligament reconstruction
Inclusion criteria consisted the quadriceps muscle strength on the injured limb was 80% or more of the uninjured limb, the range of motion of the knee joint was normal, and there was no knee pain during sports. Furthermore, it was judged that there was no problem in knee function at the doctor's examination.
Key exclusion criteria
Potential participants were excluded if they had a current or previous medical, musculoskeletal, or neurological condition that impaired their ability to perform a single leg squat.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Wataru |
| Middle name | |
| Last name | Fukuda |
Organization
Kaisei Hospital
Division name
Department of physical therapy
Zip code
762-0007
Address
3-5-28, Muro-machi, Sakaide city, Kagawa, 762-0007, Japan
TEL
0877-46-1011
fukuda_kaiseipt@hotmail.com
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Fukuda |
Organization
Kaisei hospital
Division name
Department of rehabilitation
Zip code
762-0007
Address
3-5-28, Muro-machi, Sakaide city, Kagawa, 762-0007, Japan
TEL
0877-46-1011
Homepage URL
fukuda_kaiseipt@hotmail.com
Sponsor or person
Institute
Kaisei hospital
Department of physical therapy
Institute
Department
Personal name
Funding Source
Organization
Kaisei hospital
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
Kaisei hospital, Department of physical therapy, Joint surgery center
Address
3-5-28, Muro-machi, Sakaide city, Kagawa, 762-0007, Japan
Tel
0877-46-1011
kaisei.jointreha@gmail.com
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
回生病院（香川県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 13 | 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
120
Results
The subjects were 56 anterior cruciate ligament (ACL)-injured patients and 46 healthy subjects. Patients with ACL injury exhibited greater the coefficient of variation (CV) in knee varus/valgus range of motion (ROM) during single leg squat.
The subjects were 54 patients with ACL reconstruction and 44 healthy subjects. Patients with ACL reconstruction had greater the CV in knee internal/external rotation ROM for periods that spanned 0.05 s from the initial contact during single hop landing.
Results date posted
| 2019 | Year | 08 | Month | 13 | Day |
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
| 2014 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients with anterior cruciate ligament injuries had greater variability in knee joint movement both before and after surgery.
Management information
Registered date
| 2019 | Year | 08 | Month | 13 | Day |
Last modified on
| 2022 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042511
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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