UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040477 |
|---|---|
| Receipt number | R000046200 |
| Scientific Title | Effect of cross trainer on the patients with post Total Hip Arthroplasty |
| Date of disclosure of the study information | 2020/05/22 |
| Last modified on | 2022/02/15 20:17:53 |
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Basic information
Public title
Effect of cross trainer on the patients with post Total Hip Arthroplasty
Acronym
Effect of cross trainer on the patients with post Total Hip Arthroplasty
Scientific Title
Effect of cross trainer on the patients with post Total Hip Arthroplasty
Scientific Title:Acronym
Effect of cross trainer on the patients with post Total Hip Arthroplasty
Region
| Japan |
Condition
Condition
THA
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the effects of cross-trainer on gait performance and patient satisfaction, muscle activity during gait in patients with post-THA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
muscle activity during gait in pre and post-THA (Pre, 1month post-THA, 3 month post-THA)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Other |
Interventions/Control_1
In the intervention group, in addition to the usual physical therapy, a cross-trainer was performed for 20 minutes a day from 3 to 10 th postoperate days.
Interventions/Control_2
In the control group, in addition to the usual physical therapy, a walking practice was performed for 20 minutes a day from 3 to 10 th postoperate days.
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Cases admitted to our hospital from the date of approval of ethical examination to March 31, 2022.
2. Patients who can walk 10m without using a cane preoperative.
3. A case in which postoperative physical therapy was started post unilateral total hip arthroplasty.
Key exclusion criteria
1. A case where walking without a cane was difficult preoperative.
2. Patients who underwent THA after fracture.
3. A case where the attending physician ordered ADL restriction due to postoperative complications.
4. A case with severe cognitive impairment (HDS-R 5 points or less)
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Hasebe |
Organization
Saitama Medical University Graduate School
Division name
School of Medicine
Zip code
350-0496
Address
981 Kawakado, Iruma-gun, Saitama, Japan
TEL
049-295-1001
hasebe_y@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kiyokazu |
| Middle name | |
| Last name | Akasaka |
Organization
Saitama Medical University Graduate School
Division name
School of Medicine
Zip code
350-0496
Address
981 Kawakado, Iruma-gun, Saitama, Japan
TEL
049-295-1001
Homepage URL
akasaka-smc@umin.ac.jp
Sponsor or person
Institute
Saitama Medical University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University Graduate School
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
Ethics Review Committee of Saitama Medical University Saitama Medical Center
Address
1981, Kamoda, Kawagoe, Saitama, Japan
Tel
049-228-3902
smcrinri@saitama-med.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
| 2020 | Year | 05 | Month | 22 | 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
50
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 | 07 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 21 | Day |
Last modified on
| 2022 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046200
