UMIN-CTR Clinical Trial

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
Email	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
Email	fukuda_kaiseipt@hotmail.com

Sponsor
Institute	Kaisei hospital Department of physical therapy
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042511