UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043157 |
|---|---|
| Receipt number | R000048832 |
| Scientific Title | Changes in muscle activity of ankle plantar fractures during the second half of the walking stance phase in patients with ankle fractures by wearing trunk orthosis with joints providing resistive force |
| Date of disclosure of the study information | 2021/01/28 |
| Last modified on | 2021/01/28 00:54:41 |
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Basic information
Public title
Changes in muscle activity of ankle plantar fractures during the second half of the walking stance phase in patients with ankle fractures by wearing trunk orthosis with joints providing resistive force
Acronym
Effect of trunk orthosis with joints providing resistive force on gait in patients with ankle fractures
Scientific Title
Changes in muscle activity of ankle plantar fractures during the second half of the walking stance phase in patients with ankle fractures by wearing trunk orthosis with joints providing resistive force
Scientific Title:Acronym
Effect of trunk orthosis with joints providing resistive force on gait in patients with ankle fractures
Region
| Japan |
Condition
Condition
ankle fractures
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of using trunk orthosis with joints providing resistive force alone and in combination with Nordic poles on the gait of postoperative patients with ankle fractures who are allowed to walk with full load.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-meter walking test
Muscle activity of gastrocnemius muscle (surface electromyography)
Key secondary outcomes
pain(visual analog scale)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Trunk Orthosis with joints providing resistive force
Nordic Pole
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients after ankle joint fracture surgery
Patients who have received permission from their orthopedic surgeon to practice walking with full load
Patients who can walk 10m without a walking aid
Those who meet the range of motion required for normal walking in the hip joint and ankle joint
Key exclusion criteria
Those who were unable to walk before the fracture
Persons with central nervous system disease
Persons with contraindications to the use of a Trunk Orthosis with joints providing resistive force
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kurita |
| Middle name | |
| Last name | Shinya |
Organization
Tokyo Metropolitan Health and Hospitals Corporation Ebara Hospital
Division name
Department of Rehabilitation Medicine
Zip code
145-0065
Address
4-5-10 Hhigashiyukugaya,oota-ku,Tokyo
TEL
0357348000
shinya_kurita@tokyo-hmt.jp
Public contact
Name of contact person
| 1st name | Kurita |
| Middle name | |
| Last name | Shinya |
Organization
Tokyo Metropolitan Health and Hospitals Corporation Ebara Hospital
Division name
Department of Rehabilitation Medicine
Zip code
145-0065
Address
4-5-10 Hhigashiyukugaya,oota-ku,Tokyo
TEL
0357348000
Homepage URL
shinya_kurita@tokyo-hmt.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine,Tokyo Metropolitan Health and Hospitals Corporation Ebara Hospital
Institute
Department
Personal name
Funding Source
Organization
No
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
Medicine,Tokyo Metropolitan Health and Hospitals Corporation Ebara Hospital
Address
4-5-10 Hhigashiyukugaya,oota-ku,Tokyo
Tel
0357348000
shinya_kurita@tokyo-hmt.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
| 2021 | Year | 01 | Month | 28 | 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
12
Results
Only with trunk orthosis with joints providing resistive force, the muscle activity of the lateral head of the affected gastrocnemius improved significantly, and significant improvement in walking speed was observed only after trunk orthosis with joints providing resistive force was worn and removed. No significant improvement was observed in combination with Nordic poles.
Results date posted
| 2020 | Year | 12 | Month | 17 | Day |
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
| 2019 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 28 | Day |
Last modified on
| 2021 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048832
