UMIN-CTR Clinical Trial

Public title

Is an operation device with a center of gravity measurement function (locobot) effective for improving motor function?

Acronym

Is an operation device with a center of gravity measurement function (locobot) effective for improving motor function?

Scientific Title

Is an operation device with a center of gravity measurement function (locobot) effective for improving motor function?
-Focus on motor function after total hip arthroplasty and total knee arthroplasty-

Scientific Title:Acronym

Is an operation device with a center of gravity measurement function (locobot) effective for improving motor function?

Region

Japan

Condition

Hip osteoarthritis
Knee osteoarthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to verify whether exercise using an operating device with a center of gravity measurement function (locobot) is effective for improving motor function.
The subjects are patients after total hip arthroplasty (THA) and total knee arthroplasty (TKA).

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Before surgery, 14days after surgery, 6 weeks after surgery, 3 months after surgery, 6 months after surgery , 12 months after surgery
1. Temporal and spatial factors in gait:
walking rate (cadence), stride time, step time, one-leg support time, two-legged support time, stride length, step length, and walking speed.

Key secondary outcomes

Before surgery, 14days after surgery, 6 weeks after surgery, 3 months after surgery, , 6 months after surgery , 12 months after surgery
2. Body center-of-gravity motion in gait: Vertical, lateral, and horizontal width
3. Lower limb loading rate in static standing posture
Average load, average load percentage, average load change
Maximum load, maximum load ratio, maximum load change
4. Body center of gravity sway in static upright posture:
Total trajectory length, rectangular area, external area, mean center of sway displacement
5. Time Up & Go test
6. Functional Reach test
7. Berg Balance Scale
8. One leg stand test
9. Rise test in mobility, 2-step test, Locomo 25

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Intervention period: 2 days after surgery to 12 months after surgery

Interventions/Control_2

Intervention frequency: once a day

Interventions/Control_3

Intervention time: 10 minutes

Interventions/Control_4

Intervention 1: THA, locobot/control
Intervention 2: THA, locobot/control

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

40

years-old

<=

Age-upper limit

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

Those who are over 40 years old.
Those who have undergone THA or TKA.
Those who are deemed appropriate for this study.

Key exclusion criteria

Patients who have been instructed by the attending physician to limit lower limb loads after surgery.
Those who have higher brain dysfunction or cognitive decline.
Other subjects that the person in charge of implementation judged to be inappropriate as a research subject.

Target sample size

150

Name of lead principal investigator

1st name	Etsuo
Middle name
Last name	Chosa

Organization

University of Miyazaki, Miyazaki, Miyazaki, Japan

Division name

Faculty of Medicine, Department of Orthopaedic Surgery

Zip code

889-1692

Address

5200 Kihara Kiyotake Miyazaki, Miyazaki, Japan

TEL

0985-85-0986

Email

chosa@med.miyazaki-u.ac.jp

Name of contact person

1st name	Shigeaki
Middle name
Last name	Miyazaki

Organization

University of Miyazaki Hospital, Miyazaki, Miyazaki, Japan

Division name

Rehabilitation Unit

Zip code

889-1692

Address

5200 Kihara Kiyotake Miyazaki, Miyazaki, Japan

TEL

0985-85-9849

Homepage URL

Email

03-5-23@med.miyazaki-u.ac.jp

Institute

University of Miyazaki Hospital, Miyazaki, Miyazaki, Japan

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Clinical Research Support Center, University of Miyazaki Hospital, Miyazaki, Miyazaki, Japan

Address

5200 Kihara Kiyotake Miyazaki, Miyazaki, Japan

Tel

0985-85-9403

Email

igakubu_kenkyu@med.miyazaki-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

宮崎大学医学部附属病院

Date of disclosure of the study information

2019

Year

12

Month

30

Day

URL releasing protocol

Publication of results

Partially published

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2019

Year

12

Month

30

Day

Date of IRB

2020

Year

07

Month

15

Day

Anticipated trial start date

2020

Year

04

Month

01

Day

Last follow-up date

2028

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

12

Month

30

Day

Last modified on

2023

Year

11

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044508