UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047527 |
|---|---|
| Receipt number | R000054204 |
| Scientific Title | Can Telerehabilitation Improve Physical Activity After Lower Extremity Arthroplasty? (Preliminary randomized controlled trial study) |
| Date of disclosure of the study information | 2022/04/20 |
| Last modified on | 2022/04/20 12:16:42 |
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Basic information
Public title
Can Telerehabilitation Improve Physical Activity After Lower Extremity Arthroplasty?
Acronym
Can Telerehabilitation Improve Physical Activity After Lower Extremity Arthroplasty?
Scientific Title
Can Telerehabilitation Improve Physical Activity After Lower Extremity Arthroplasty?
(Preliminary randomized controlled trial study)
Scientific Title:Acronym
Can Telerehabilitation Improve Physical Activity After Lower Extremity Arthroplasty?
(Preliminary randomized controlled trial study)
Region
| Japan |
Condition
Condition
Total hip arthroplasty,
Total knee arthroplasty
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine whether Telerehabilitation improves physical activity in long-term postoperative THA and TKA patients. This study is also a preliminary study and will be conducted to estimate the sample size for conducting this study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in physical activity after 12 weeks
Key secondary outcomes
Amount of change in physical activity after 24 weeks
Change in the following items at 12 and 24 weeks
1) Presence of physical frailty
2) Locomotive syndrome risk test
3) SPPB (Short physical performance battery)
4) One-leg standing time
5) Grip strength
6) JOA score (hip and knee joints)
7) Patient-oriented outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Telerehabilitation for exercise instruction and remote management of activity levels.
Interventions/Control_2
Provide exercise guidance and self-monitoring of activity levels.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who have been undergoing lower limb arthroplasty for at least 6 months at Dr. Ida's outpatient clinic
2.Patients with 65 years or older
3.Patients for whom written consent has been obtained from the patient
Key exclusion criteria
1.Patients with cognitive decline (MMSE below 23 or HDS-R below 20)
2.Patients with any of the following postoperative complications: intraoperative fracture, DVT, or infection.
3. Patients who are deemed inappropriate for this study by the principal investigator and research partners.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kunio |
| Middle name | |
| Last name | Ida |
Organization
Sanjinkai Asahi Hospital
Division name
Department of Orthopedics
Zip code
486-0819
Address
2090, Aza-Murahigashi, Shimohara-cho, Kasugai, Aichi
TEL
0568-85-0077
idak@estate.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Takenaka |
Organization
Sanjinkai Asahi Hospital
Division name
Department of Rehabilitation
Zip code
486-0819
Address
2090, Aza-Murahigashi, Shimohara-cho, Kasugai, Aichi
TEL
0568-85-0077
Homepage URL
hiroto.takenaka@gmail.com
Sponsor or person
Institute
Sanjinkai Asahi Hospital
Institute
Department
Personal name
Funding Source
Organization
Sanjinkai Asahi Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamauchi Clinic IRB
Address
1-15-19, Jiyugaoka, Meguro Ku, Tokyo To, Japan
Tel
03-5575-5862
c-irb_ug@neues.co.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
| 2022 | Year | 04 | Month | 20 | 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
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 04 | 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 | 04 | Month | 19 | Day |
Last modified on
| 2022 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054204
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
