UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039630 |
|---|---|
| Receipt number | R000045199 |
| Scientific Title | Effect of neuromuscular electrical stimulation on individual quadriceps muscle atrophy in patients with non-weight bearing: A randomized control study |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2024/08/28 10:39:20 |
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Basic information
Public title
Effect of neuromuscular electrical stimulation on individual quadriceps muscle atrophy in patients with non-weight bearing: A randomized control study
Acronym
Effect of neuromuscular electrical stimulation on individual quadriceps muscle atrophy
Scientific Title
Effect of neuromuscular electrical stimulation on individual quadriceps muscle atrophy in patients with non-weight bearing: A randomized control study
Scientific Title:Acronym
Effect of neuromuscular electrical stimulation on individual quadriceps muscle atrophy
Region
| Japan |
Condition
Condition
Ankle and foot fractures
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the efficacy of neuromuscular electrical stimulation against quadriceps muscle atrophy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Individual QM thicknesses are measured 1 week after starting non-weight bearing, immediately before starting weight bearing, and the end of rehabilitation.
Key secondary outcomes
Clinical symptoms are assessed with patients-reported outcome measures: the SAFE-Q at the end of rehabilitation. Strengthening and tightness of QM are measured at the end of rehabilitation.
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
| Device,equipment |
Interventions/Control_1
During non-weight bearing, home exercises are performed by themselves; open kinetic chain exercises including knee flexion and extension, and hip abduction and adduction 30 times per day.
Interventions/Control_2
In addition to the home exercises, neuromuscular electrical stimulation is performed during knee flexion and extension exercise for 10 minutes twice per a week at hospital during non-weight bearing.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria is a patient who are diagnosed as ankle and foot fractures by orthopedic examinations, who are required conservative therapy including non-weight bearing and ankle immobilization using cast for 4 weeks.
Key exclusion criteria
Exclusion criteria is a patient with a history of the leg fracture and surgeries, and hip and/or knee osteoarthritis.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koun |
| Middle name | |
| Last name | Yamauchi |
Organization
Akita hospital
Division name
Department of orthopedic surgery
Zip code
4720056
Address
2-6-12 Takara, Chiryu City, Aichi, Japan
TEL
0566-81-2763
koun_mail_world@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamada |
Organization
Akita hospital
Division name
Research support division
Zip code
4720056
Address
2-6-12 Takara, Chiryu City, Aichi, Japan
TEL
0566-81-2763
Homepage URL
a-ijika@akitahospital.or.jp
Sponsor or person
Institute
Akita hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Akita hospital IRB
Address
2-6-12 Takara, Chiryu City, Aichi, Japan
Tel
0566-81-2763
a-ijika@akitahospital.or.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 | 03 | Month | 01 | Day |
Related information
URL releasing protocol
no
Publication of results
Unpublished
Result
URL related to results and publications
analysing
Number of participants that the trial has enrolled
20
Results
There were no significant differences for preventing QF muscle atrophy between NMES use and control.
Results date posted
| 2024 | Year | 08 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twenty patinets.
Participant flow
No detail
Adverse events
Nothing
Outcome measures
Measurement of QF thickness and knee extension maximum isometric contraction strength
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2020 | Year | 02 | Month | 28 | Day |
Last modified on
| 2024 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045199
