UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048550 |
|---|---|
| Receipt number | R000055320 |
| Scientific Title | Efficacy of Toe Grip Training after Total Knee Arthroplasty |
| Date of disclosure of the study information | 2022/08/03 |
| Last modified on | 2023/11/16 18:07:04 |
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Basic information
Public title
Efficacy of Toe Grip Training after Total Knee Arthroplasty
Acronym
Efficacy of Toe Grip Training after Total Knee Arthroplasty
Scientific Title
Efficacy of Toe Grip Training after Total Knee Arthroplasty
Scientific Title:Acronym
Efficacy of Toe Grip Training after Total Knee Arthroplasty
Region
| Japan |
Condition
Condition
Postoperative osteoarthritis of the knee
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of toe grip training on postoperative movement ability after total knee arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Movement ability (Timed up and go test), Toe grip strength
Key secondary outcomes
age, sex, height, weight, Body mass index, walking style, Type of implant, operative side (right or left), severity (K-L grade), fall of pre-postoperatively, rest and walking pain, Knee extension strength, modified Fall Efficacy Scale, KOOS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention group: Postoperative toe grip strength training (at least 4 times a week during hospitalization on the 7th postoperative day and at home after the other hospitalization) and usual outpatient physical therapy (once a week or once every 2 weeks) at home for 3 months after the TKA surgery.
Interventions/Control_2
Control group: usual outpatient physical therapy (once a week or once every 2 weeks) for 3 months postoperatively.
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-Participants who had undergone total knee arthroplasty with a diagnosis of osteoarthritis and were at least 60 years old and less than 90 years old.
-Participants who were able to walk with a cane or by themselves before and at 3 months and 1 year after TKA, and who were able to complete physical therapy evaluations and questionnaires.
-Participants who gave informed consent for this study and signed a consent form.
Key exclusion criteria
-Participants with significant impairment in basic activities such as toe-grasp training and gait due to flexion disorders of the toes, other neurological disorders, or other musculoskeletal disorders.
-Participants with severe depression or dementia who have difficulty with assessment.
-Participants who have undergone contralateral total knee arthroplasty.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Mawarikado |
Organization
Nara medical University
Division name
Graduate School of Medicine, Musculoskeletal Reconstructive Surgery
Zip code
634-8521
Address
840 Shijocho, Kashihara, Nara
TEL
0744223051
K115877@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Mawarikado |
Organization
Nara medical University
Division name
Graduate School of Medicine, Musculoskeletal Reconstructive Surgery
Zip code
634-8521
Address
840 Shijocho, Kashihara, Nara
TEL
0744223051
Homepage URL
K115877@naramed-u.ac.jp
Sponsor or person
Institute
Nara medical university
Institute
Department
Personal name
Funding Source
Organization
Nara medical university
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
Nara medical university
Address
840 Shijocho, Kashihara, Nara, Japan
Tel
0744-22-3051
K115877@naramed-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2020-04-21-007
Org. issuing International ID_1
Kashiba Asahigaoka Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 03 | 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
76
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
Main results already published
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 02 | Day |
Last modified on
| 2023 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055320
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| Registered date | File name |
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