UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000048550
Receipt No. 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 2022/08/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 and fall-related self-efficacy and health-related quality of life 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, Gait speed), modified Fall Efficacy Scale, KOOS
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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
Email 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
Email K115877@naramed-u.ac.jp

Sponsor
Institute Nara medical university
Institute
Department

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
Email 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 No longer recruiting
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
2022 Year 08 Month 02 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055320

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.