UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052086 |
|---|---|
| Receipt number | R000059448 |
| Scientific Title | Therapeutic effect of knee extension exercise with single-joint hybrid assistive limb following total knee arthroplasty: A Prospective, Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2024/02/18 10:34:13 |
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Basic information
Public title
Therapeutic effect of knee extension exercise with single-joint hybrid assistive limb following total knee arthroplasty
Acronym
The effect of knee exercise with the robot after total knee arthroplasty
Scientific Title
Therapeutic effect of knee extension exercise with single-joint hybrid assistive limb following total knee arthroplasty: A Prospective, Randomized Controlled Trial
Scientific Title:Acronym
Therapeutic effect of knee extension exercise with single-joint hybrid assistive limb following total knee arthroplasty: A Prospective, Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Knee osteoarthritis
After total knee arthroplasty
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the therapeutic effect of knee extension exercise with the single-joint hybrid assistive limb on the acute phase after total knee arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain intensity on knee motion
Active knee extension angle
Passive knee extension angle
Evaluate preoperatively, postoperative days 1 to 10, and weeks 2 and 4.
Key secondary outcomes
Walking speed
Timed up and Go test
Isometric knee extension strength
Knee injury and Osteoarthritis Outcome Score (KOOS)
Evaluate preoperatively and on postoperative weeks 2 and 4.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The patients in intervention group performed knee extension exercises with robot suit HAL single joint 50 times per day. The intervention was performed 5 times per week, and a total of 10 times.
Interventions/Control_2
The patients in intervention group performed knee extension exercises without robot suit HAL single joint 50 times per day. The intervention was performed 5 times per week, and a total of 10 times.
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
The patients with end-stage knee osteoarthritis and scheduled primary total knee arthroplasty
Key exclusion criteria
History of a serious peripheral circulatory disturbance
Heart or respiratory problems
Central or peripheral neurological disorders
Dementia
spinal disease with lower extremity symptoms
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Takaya |
| Middle name | |
| Last name | Maeda |
Organization
Hirosaki Memorial Hospital
Division name
Department of Rehabilitation
Zip code
036-8102
Address
59-1, sakaizekinishida, Hirosaki, Aomori, Japan
TEL
0172-28-1211
t.maeda.hirosaki@gmail.com
Public contact
Name of contact person
| 1st name | Takaya |
| Middle name | |
| Last name | Maeda |
Organization
Hirosaki Memorial Hospital
Division name
Department of Rehabilitation
Zip code
0368076
Address
59-1, sakaizekinishida, Hirosaki, Aomori, Japan
TEL
0172281211
Homepage URL
t.maeda.hirosaki@gmail.com
Sponsor or person
Institute
Hirosaki Memorial Hospital
Institute
Department
Personal name
Takaya Maeda
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
Hirosaki Memorial Hospital ethics committee
Address
59-1, sakaizekinishida, Hirosaki, Aomori, Japan
Tel
0172-28-1211
atsu-ono@triton.ocn.ne.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
弘前記念病院(青森県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://dx.doi.org/10.1038/s41598-024-53891-7
Number of participants that the trial has enrolled
76
Results
The HAL-SJ group significantly improved active and passive knee extension angles compared with the CPT group.
The HAL-SJ group showed immediate improvement in active knee extension angle through day 5. There were no significant differences in results between the performance tests and KOOS.
Knee extension exercises with the HAL-SJ improved knee pain and the angle of extension in the acute phase after TKA.
Results date posted
| 2024 | Year | 02 | Month | 18 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
To be submitted for publication
Date of the first journal publication of results
Baseline Characteristics
The patients with end-stage knee osteoarthritis and scheduled primary total knee arthroplasty
Participant flow
The patients who matched the inclusion criteria and agree to the study were invited to the intervention group or conventional group.
The patients evaluated the above-mentioned pre-operation and started intervention 4 days after operation.
The pain intensity on knee motion and knee extension angle were evaluated before and after each intervention.
the evaluations were performed 2 and 4 weeks after operation.
Adverse events
None
Outcome measures
Pain intensity on knee motion
Active knee extension angle
Passive knee extension angle
Walking ability
Timed up and Go test
Isometric knee extension strength
Knee injury and Osteoarthritis Outcome Score (KOOS)
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 26 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 16 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 16 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 01 | Day |
Last modified on
| 2024 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059448
