UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053675 |
|---|---|
| Receipt number | R000060567 |
| Scientific Title | Assessment of functional recovery of rehabilitation with assistance from a single-joint hybrid assistive limb in patients with orthopedic surgery |
| Date of disclosure of the study information | 2024/02/21 |
| Last modified on | 2024/02/21 15:43:28 |
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Basic information
Public title
Efficacy of rehabilitation with assistance from a robotic assisted rehabilitation "single-joint hybrid assistive limb" in patients with orthopedic surgery
Acronym
Efficacy of rehabilitation with assistance from a single-joint hybrid assistive limb in patients with orthopedic surgery
Scientific Title
Assessment of functional recovery of rehabilitation with assistance from a single-joint hybrid assistive limb in patients with orthopedic surgery
Scientific Title:Acronym
Assessment of rehabilitation with assistance from a single-joint hybrid assistive limb in patients with orthopedic surgery
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to clarify that the safety and effectiveness of knee exercise after TKA using HAL-SJ.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The evaluation period is preoperative (one day before surgery), 2 weeks and 12 months after TKA.
Key secondary outcomes
KOOS and KSS questionnaire
The evaluation period is preoperative (one day before surgery) and 12 months after TKA.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The intervention group sat in bed and performed extension and flexion of the knee joint for the affected knee using HAL-SJ. Five sets of 10 repetitions were performed three times per week.
Interventions/Control_2
The control group sat in rehabilitation focused on range of motion exercises, sitting and standing positions.
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
| 50 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with osteoarthritis of the knee scheduled for initial total knee arthroplasty.
Key exclusion criteria
1:dementia cases
2:rheumatoid arthritis cases
3:neurological diseases cases
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Taniguhi |
Organization
Kanazawa University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
920-8641
Address
Takaramachi 13-1, Kanazawa city, Ishikawa pref.
TEL
076-265-2000
yutataniguchi0925@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takaya |
| Middle name | |
| Last name | Watabe |
Organization
Kanazawa University Hospital
Division name
Section of Rehabilitation
Zip code
920-8641
Address
Takaramachi 13-1, Kanazawa city, Ishikawa pref.
TEL
076-265-2000
Homepage URL
takaya.watabe@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
None
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
Kanazawa University
Address
Takaramachi 13-1, Kanazawa city, Ishikawa pref.
Tel
076-265-2110
rinri@adm.kanazawa-u.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
金沢大学附属病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 21 | 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
80
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 21 | Day |
Last modified on
| 2024 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060567
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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