UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056040 |
|---|---|
| Receipt number | R000064043 |
| Scientific Title | Long-term effects of Foam rolling on patients after surgery for Proximal Femur fractures |
| Date of disclosure of the study information | 2024/11/05 |
| Last modified on | 2024/11/04 22:25:00 |
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Basic information
Public title
Long-term effects of Foam rolling on patients after surgery for Proximal Femur fractures
Acronym
Long-term effects of Foam rolling on patients after surgery for Proximal Femur fractures
Scientific Title
Long-term effects of Foam rolling on patients after surgery for Proximal Femur fractures
Scientific Title:Acronym
Long-term effects of Foam rolling on patients after surgery for Proximal Femur fractures
Region
| Japan |
Condition
Condition
Proximal Femur fractures
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of foam rollers on patients after surgery for proximal femur fractures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The measured items were pain, hip flexion ROM, hip extension ROM, knee flexion ROM, knee extension ROM, 10-m walk speed, timed up and go test (TUG), and maximal voluntary isometric contraction (MVIC) torques of hip flexors and knee extensors. All ROM measurements were performed with passive motion.
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
In addition to regular physical therapy, we will compare the groups that use foam rollers with those that do not.
Interventions/Control_2
regular physical therapy only
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have undergone surgery for a proximal femur fracture and who have given their consent to the aims of the study
Key exclusion criteria
The exclusion criteria were: those who did not consent to the purpose of this study, those who required postoperative immobilization for a certain time, and those with a diagnosis of dementia in their current medical history.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masanobu |
| Middle name | |
| Last name | Yokochi |
Organization
Takeda General Hospital
Division name
Department of Rehabilitation
Zip code
965-8585
Address
3-27 Yamagamachi, Aizuwakamatsu, Fukushima
TEL
0242275511
masanobu3250@gmail.com
Public contact
Name of contact person
| 1st name | Masanobu |
| Middle name | |
| Last name | Yokochi |
Organization
Takeda General Hospital
Division name
Department of Rehabilitation
Zip code
965-8585
Address
3-27 Yamagamachi, Aizuwakamatsu, Fukushima
TEL
0242275511
Homepage URL
masanobu3250@gmail.com
Sponsor or person
Institute
Takeda General Hospital
Institute
Department
Personal name
Funding Source
Organization
Takeda General Hospital
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takeda General Hospital
Address
3-27 Yamagamachi, Aizuwakamatsu, Fukushima
Tel
0242275511
masanobu3250@gmail.com
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
| 2024 | Year | 11 | 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
44
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
| 2022 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 11 | Month | 04 | Day |
Last modified on
| 2024 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064043
