UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046811 |
|---|---|
| Receipt number | R000053415 |
| Scientific Title | Intervention effect of telerehabilitation for patients with lower-limb joint replacement |
| Date of disclosure of the study information | 2022/02/05 |
| Last modified on | 2022/12/11 11:39:00 |
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Basic information
Public title
Intervention effect of telerehabilitation for patients with lower-limb joint replacement
Acronym
Intervention effect of telerehabilitation for patients with lower-limb joint replacement
Scientific Title
Intervention effect of telerehabilitation for patients with lower-limb joint replacement
Scientific Title:Acronym
Intervention effect of telerehabilitation for patients with lower-limb joint replacement
Region
| Japan |
Condition
Condition
Total knee arthroplasty/Total hip arthroplasty
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness and feasibility of post-discharge telerehabilitation on the inprovement of physical function
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Timed up and go test/six minutes walking test
Key secondary outcomes
pain(numerical rating scale, Pain Catastrophizing Scale, satisfaction, pain self-efficacy questionnaire, Life-Space Assessment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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 | Behavior,custom | Maneuver |
Interventions/Control_1
telerehabilitaiton (voluntary training while watching exercise video 5 times a week for 30 minutes once) and outpatient rehabilitaiton onece for week
Interventions/Control_2
outpatient rehabilitaiton only (onece for week)
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elderly who are hospitalized to initial TKA or THA and undergo outpatient follow-up after discharge
Key exclusion criteria
1. If you have difficulty walking before admission, 2. If you have neuromuscular or cerebrovascular disease, 3. If you do not have the understanding and cooperation of the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Kishimoto |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Physical Therapy
Zip code
701-0193
Address
288, Matsushima, Kurashiki Okayama 701-0193, Japan
TEL
086-462-1111
t-kishi@mw.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Kishimoto |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Physical Therapy
Zip code
701-0193
Address
288, Matsushima, Kurashiki Okayama 701-0193, Japan
TEL
086-462-1111
Homepage URL
t-kishi@mw.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki University of Medical Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical corporation Nijinkai Ishikawa Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki University of Medical Welfare
Address
288, Matsushima, Kurashiki Okayama 701-0193, Japan
Tel
09052621579
t-kishi@mw.kawasaki-m.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 05 | 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
60
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 | 12 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | 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 | 02 | Month | 03 | Day |
Last modified on
| 2022 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053415
