UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022550 |
|---|---|
| Receipt number | R000025515 |
| Scientific Title | Effect of walking training using walker with weight bearing lift on the recovery of activities of daily living after surgery for hip fracture repair |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2023/12/05 10:08:07 |
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Basic information
Public title
Effect of walking training using walker with weight bearing lift on the recovery of activities of daily living after surgery for hip fracture repair
Acronym
Effect of walking training using walker with weight bearing lift on the recovery of activities of daily living after surgery for hip fracture repair
Scientific Title
Effect of walking training using walker with weight bearing lift on the recovery of activities of daily living after surgery for hip fracture repair
Scientific Title:Acronym
Effect of walking training using walker with weight bearing lift on the recovery of activities of daily living after surgery for hip fracture repair
Region
| Japan |
Condition
Condition
Hip Fracture
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of walking training using walker with weight bearing lift on the recovery of activities of daily living after surgery for hip fracture repair.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ADL (Barthel Index): at 2 weeks, 6 months, 9 months, and 1 year after surgery
Key secondary outcomes
nursing care level: at 1 year after surgery
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 |
Interventions/Control_1
Standard rehabilitation program using walker with weight bearing lift. The estimated period of use: starting from an early stage after surgery to discharge from acute hospital(maximum), frequency: one time (10-20 minutes)). Rehabilitation program are generally based on clinical path adapted in each hospital. Lead principal investigator is not involved in minor change of program and clinical path.
Interventions/Control_2
Standard rehabilitation program. Conventional walker owned in the hospital is used in walking training. Rehabilitation program are generally based on clinical path adapted in each hospital. Lead principal investigator is not involved in minor change of program and clinical path.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)fractured the proximal part of their femur
2)underwent a surgery, such as a femoral head replacement
3)degree of independent daily living for the disabled elderly of J or A
4)independent daily living score for the demented elderly of 1 or 2
Key exclusion criteria
1)the existence of hip fracture on the opposite side
2)multiple fractures
3)no permit for weight bearing immediately after surgery
4)pathological fracture
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryo Tanaka |
Organization
Hiroshima International University
Division name
Department of Rehabilitation, Faculty of Rehabilitation
Zip code
Address
555-36, Kurose-gauendai, Higashi-hiroshima, Hiroshima
TEL
0823-70-4914
r-tanaka@hs.hirokoku-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Tanaka |
Organization
Hiroshima International University
Division name
Department of Rehabilitation, Faculty of Rehabilitation
Zip code
Address
555-36, Kurose-gauendai, Higashi-hiroshima, Hiroshima
TEL
0823-70-4914
Homepage URL
r-tanaka@hs.hirokoku-u.ac.jp
Sponsor or person
Institute
Hiroshima International University
Institute
Department
Personal name
Funding Source
Organization
MHLW(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 06 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment is performed between September 2015 and March 2017. Patients are selected only who provide written informed consent. Measurement items include pre-rehabilitation baseline data (age, sex, gait method, place of residence, ADL level, nursing care level, type of fracture, and surgical method). ADL disabilities, Chair-stand-30 (CS-30) test results, and pain intensity at 2 weeks after surgery are also included. The data of ADL level and nursing care level are collected by 1 year after surgery. In this study, the data of our observational study "Screening tool development for predicting the declines in activities of daily living and nursing care level after surgery for hip fracture repair" (UMIN000022216) are also used.
Management information
Registered date
| 2016 | Year | 05 | Month | 31 | Day |
Last modified on
| 2023 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025515
