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Clinical Evaluation of Usefulness and Effectiveness of Sitting Type Continuous Passive Motion Machine for Patients with Knee Joint Surgery

Status Approved

  • First Submitted Date

    2020/10/14

  • Registered Date

    2020/10/21

  • Last Updated Date

    2024/01/25

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number    		 KCT0005520
    Unique Protocol ID CNUH2020-07-028-002
    Public/Brief Title Clinical Evaluation of Usefulness and Effectiveness of Sitting Type Continuous Passive Motion Machine for Patients with Knee Joint Surgery
    Scientific Title Clinical Evaluation of Usefulness and Effectiveness of Sitting Type Continuous Passive Motion Machine for Patients with Knee Joint Surgery
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Submitted approval

  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2020-07-028-002
    Approval Date 2020-09-02
    Institutional Review Board Name Chungnam national university hospital institutional review board
    Institutional Review Board Address 282, Munhwa-ro, Jung-gu, Daejeon
    Institutional Review Board Telephone 042-280-8715
    Data Monitoring Committee No

  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Kang-hee Cho
    Title Professor
    Telephone +82-42-338-2355
    Affiliation Chungnam National University Hospital
    Address 282, Munhwa-ro, Jung-gu, Daejeon
    Contact Person for Public Queries
    Name Chang-won Moon
    Title Professor
    Telephone +82-42-338-2406
    Affiliation Chungnam National University Hospital
    Address 282, Munhwa-ro, Jung-gu, Daejeon
    Contact Person for Updating Information
    Name Woo-sung Choi
    Title Research Engineer
    Telephone +82-42-338-2985
    Affiliation Chungnam National University Hospital
    Address 282, Munhwa-ro, Jung-gu, Daejeon

  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 2
    Overall Recruitment Status Completed
    Date of First Enrollment 2020-11-10 Actual
    Target Number of Participant 210
    Primary Completion Date 2023-03-30 , Actual
    Study Completion Date 2023-03-30 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study The Catholic University of Korea, Daejeon St. Mary's Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-11-11 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Chungnam National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2020-11-10 ,

  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Korea Medical Device Development Fund
    Organization Type Government
    Project ID KMDF_PR_20200901_023

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Chungnam National University
    Organization Type University

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    Postoperative joint movement exercise is essential to prevent joint construction, restore function, and reduce edema after knee joint surgery such as total knee arthroplasty, knee ligament reconstruction, and fixation after knee fracture. Joint movement exercise after knee joint surgery is performed through passive joint movement exercise by a physical therapist, passive joint movement using a continuous passive motion (CPM) machine, and self-manual joint movement through education of patients and guardians. Due to the limited rehabilitation medical cost, passive joint movement exercise by physical therapists is offered generally a maximum of 10 minutes per day. And self-manual joint exercises are not performed at a high rate. Therefore, most of the joint movement exercises are performed through a continuous passive motion machine. The traditional CPM machine is a lying type, and there is a severe gap between the actual patient's range of motion (joint angle) and the machine's range of motion. Hence, it is difficult to clarify the effectiveness because of the subjective setting of the range of motion of the CPM machine. The recently developed sitting type CPM machine is currently the only type domestically and internationally. And it is expected to have an advantage in setting the machine motion range as there is a little gap between the actual patient's range of motion and the machine's range of motion. However, there are no clinical studies.
 This study is a single-blind randomized controlled trial for clinical evaluation of the effectiveness of the use of a lying type(traditional) CPM machine and a sitting type CPM machine in patients with total knee arthroplasty. To improving the methodological defects of existing CPM machine-related studies, the blind evaluator measures the patient's actual range of motion of the knee joint before applying the CPM machine, and set the corresponding machine value. Through this increases the objectivity of the study results and verifies power through a large-scale randomized controlled study.

  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose 
    Treatment
    Phase Phase1
    Intervention Model Factorial  
    Blinding/Masking Single
    Blinded Subject Investigator
    Allocation RCT
    Intervention Type Medical Device  
    Intervention Description 
    Group 1. Lying-type CPM group: Adaptation training and intervention using a lying-type CPM machine were conducted twice a day for a total of 10 days

Group 2-1. Lying-type and Sitting-type CPM complex group-1: Adaptation training and 4 interventions using a lying-type CPM machine were conducted twice a day for a total of 5 days, after that, intervention using the sitting-type CPM machine twice a day for a total of 5 days

Group 2-2. Lying-type and Sitting-type CPM complex group-2: Adaptation training and 4 interventions using sitting-type CPM machine were conducted twice a day for a total of 5 days, after that, intervention using the lying-type CPM machine twice a day for a total of 5 days

Group 3. Sitting-type CPM group: Adaptation training and intervention using a sitting-type CPM machine were conducted twice a day for a total of 10 days
    Number of Arms 3
    Arm 1

    Arm Label

    Lying-type CPM group

    Target Number of Participant

    70

    Arm Type

    Active comparator

    Arm Description

    1st session - CPM adaptation training using a lying-type CPM machine
-Range of motion: Based on the passive range of motion(PROM), flexion +10 degrees
-Intervention time: 30 minutes each in the morning and afternoon, twice a day

2nd-10th session - Intervention using a lying-type CPM machine
-Range of motion: Based on the passive range of motion(PROM), flexion +10 degrees
-Intervention time: 60 minutes each in the morning and afternoon, twice a day

-Intervention period: 10 times/week, total 20 times for 2weeks
    Arm 2

    Arm Label

    Lying-type and sitting-type CPM complex group

    Target Number of Participant

    70

    Arm Type

    Active comparator

    Arm Description

    To minimize the disturbance according to the type of CPM machine performed at the beginning of the operation in the complex group, it was divided into 2 groups through random assignment, and the order was changed and applied.

1) Lying-type to Sitting-type CPM complex group

1st session - CPM adaptation training using a lying-type CPM machine
-Range of motion: Based on the passive range of motion(PROM), flexion +10 degrees
-Intervention time: 30 minutes each in the morning and afternoon, twice a day

2nd-5th session - Intervention using a lying-type CPM machine
-Range of motion: Based on the PROM, flexion +10 degrees
-Intervention time: 60 minutes each in the morning and afternoon, twice a day

6th-10th session - Intervention using a sitting-type CPM machine
-Range of motion: Based on the PROM, flexion +10 degrees
-Intervention time: 60 minutes each in the morning and afternoon, twice a day

-Intervention period: 10 times/week, total 20 times for 2weeks

1) Sitting-type to Lying-type CPM complex group

1st session - CPM adaptation training using a sitting-type CPM machine
-Range of motion: Based on the passive range of motion(PROM), flexion -10 degrees
-Intervention time: 30 minutes each in the morning and afternoon, twice a day

2nd-5th session - Intervention using a sitting-type CPM machine
-Range of motion: Based on the PROM, extension -10 degrees, flexion +10 degrees
-Intervention time: 60 minutes each in the morning and afternoon, twice a day

6th-10th session - Intervention using a lying-type CPM machine
-Range of motion: Based on the PROM, extension -10 degrees, flexion +10 degrees
-Intervention time: 60 minutes each in the morning and afternoon, twice a day

-Intervention period: 10 times/week, total 20 times for 2weeks
    Arm 3

    Arm Label

    Sitting-type CMP group

    Target Number of Participant

    70

    Arm Type

    Experimental

    Arm Description

    1st session - CPM adaptation training using a sitting-type CPM machine
-Range of motion: Based on the passive range of motion(PROM), flexion +10 degrees
-Intervention time: 30 minutes each in the morning and afternoon, twice a day

2nd-10th session - Intervention using a sitting-type CPM machine
-Range of motion: Based on the PROM, flexion +10 degrees
-Intervention time: 60 minutes each in the morning and afternoon, twice a day

-Intervention period: 10 times/week, total 20 times for 2weeks

  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (M00-M99)Diseases of the musculoskeletal system and connective tissue 
       (M13.96)Arthritis, unspecified, lower leg 

    Subjects who receive unilateral total knee arthroplasty patients
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    patients planned to receive primary unilateral TKA due to degenerative changes. Other inclusion criteria will be as follows;
1) age 19 years or older.
2) The patient agrees to participate in this randomized trial.
    Exclusion Criteria 
    The exclusion criteria will be as follows;
1) age under 60 years old, or over 90 years old
2) other causes of arthritis than degenerative changes (infection, traumatic, and inflammatory joint disease)
3) history of previous hip, knee, and ankle orthopedic surgery
4) history of previous lumbar surgery within 3month of study
5) serious nervous system, cardiovascular diseases, or osteoporosis
6) having coagulation disorders
7) obese patient whose body mass index is more than 35kg/m2
8) inability to understand the study protocols due to cognitive deficits or language problems
9) refuse to participate
    Healthy Volunteers No

  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome 
    Passive range of motion
    Timepoint 
    2020.10. -
    Secondary Outcome(s) 1
    Outcome 
    Pain (Numeric rating scale)
    Timepoint 
    2020.10. -
    Secondary Outcome(s) 2
    Outcome 
    Western Ontario and McMaster universities osteoarthritis (WOMAC)
    Timepoint 
    2020.10. -
    Secondary Outcome(s) 3
    Outcome 
    Knee Society Score (KSS)
    Timepoint 
    2020.10. -
    Secondary Outcome(s) 4
    Outcome 
    Kujala Score
    Timepoint 
    2020.10. -
    Secondary Outcome(s) 5
    Outcome 
    Patient's satisfaction questionnaire
    Timepoint 
    2020.10. -
    Secondary Outcome(s) 6
    Outcome 
    Swelling of lower limb measured by circumference (10cm above patella upper pole, 10cm below the tibial tuberosity)
    Timepoint 
    2020.10. -
    Secondary Outcome(s) 7
    Outcome 
    Time Up and Go Test (TUG)
    Timepoint 
    2020.10. -
    Secondary Outcome(s) 8
    Outcome 
    6m Walking Test (6MWT)
    Timepoint 
    2020.10. -
    Secondary Outcome(s) 9
    Outcome 
    Isokinetic strengthening of flexion and extension in knee joint
    Timepoint 
    2020.10. -
    Secondary Outcome(s) 10
    Outcome 
    Active range of motion in knee joint
    Timepoint 
    2020.10. -

  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No

  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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