UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054889 |
|---|---|
| Receipt number | R000062411 |
| Scientific Title | Efficacy and duration of robotic gait training for post-artificial joint surgery patients |
| Date of disclosure of the study information | 2024/07/05 |
| Last modified on | 2024/07/04 16:51:08 |
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Basic information
Public title
Efficacy and duration of robotic gait training for post-artificial joint surgery patients
Acronym
Efficacy and duration of robotic gait training for post-artificial joint surgery patients
Scientific Title
Efficacy and duration of robotic gait training for post-artificial joint surgery patients
Scientific Title:Acronym
Efficacy and duration of robotic gait training for post-artificial joint surgery patients
Region
| Japan |
Condition
Condition
Patients with osteoarthritis, including those who have undergone total knee replacement
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study was to determine the effects of robot-assissted gait training (RAGT) on walking ability, physical function, and pain in a group of patients who underwent RAGT for 1 to 2 weeks postoperatively. The secondary objective was to evaluate the degree of effort and training intensity of RAGT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Walking speed: Self-selected walking speed (SWS), and Maximum walking speed (MWS)
*Measurements were typically taken preoperatively, 2 weeks postoperatively, 4 weeks postoperatively, and 8 weeks postoperatively
Key secondary outcomes
Average step length at SWS and MWS
Cadence at SWS and MWS
Range of motion of knee extension (passive and active)
Range of motion of knee flexion (passive and active)
Maximum torque in knee extension and flexion
Maximum torque in knee flexion
Western Ontario and McMaster Universities osteoarthritis index (WOMAC) pain subscale (WOMAC-p) and physical function subscale (WOMAC-f)
*Measurements were typically taken preoperatively, 2 weeks postoperatively, 4 weeks postoperatively, and 8 weeks postoperatively
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients admitted to the hospital or outpatients who are able to practice walking
Key exclusion criteria
1) Those who are under 20 years of age
2) Those whose height is less than 140 cm.
3) Those with significant cognitive decline or higher brain dysfunction
4) Persons who use a pacemaker
5) Patients who have difficulty wearing the HWA-01.
6) Others who are judged by the attending physician to be unable to participate.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Mutsuzaki |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Center for Medical Sciences
Zip code
300-0394
Address
4669-2 Ami, Inashiki-gun, Ibaraki
TEL
029-888-4000
mutsuzaki@ipu.ac.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Mutsuzaki |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Center for Medical Sciences
Zip code
300-0394
Address
4669-2 Ami, Inashiki-gun, Ibaraki
TEL
029-888-4000
Homepage URL
mutsuzaki@ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefectural University of Health Sciences
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
Ethics Committee of the Ibaraki Prefectural University of Health Sciences
Address
4669-2 Ami, Inashiki-gun, Ibaraki
Tel
029-888-4000
kyoumu@ipu.ac.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 | 07 | Month | 05 | 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
51
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
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
#Study Design
Case-control study
#Subjects to be observed
Patients who were hospitalized and underwent total knee arthroplasty between May 2020 and May 2023, and who met the selection and exclusion criteria.
#Items to be measured
Patient background information such as age, gender, weight, and height.
Gait function, knee joint range of motion, knee function and pain, and knee joint muscle strength at preoperative, 2 weeks postoperative, 4 weeks postoperative, and 8 weeks postoperative periods (details of the evaluation items are described in a separate section).
Management information
Registered date
| 2024 | Year | 07 | Month | 05 | Day |
Last modified on
| 2024 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062411
