UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041303 |
|---|---|
| Receipt number | R000046457 |
| Scientific Title | Safety and efficacy of lower limb Neuromuscular Electrical Stimulation in persons with acute spinal cord injury |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2024/01/13 22:23:42 |
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Basic information
Public title
Safety and efficacy of lower limb Neuromuscular Electrical Stimulation in persons with acute spinal cord injury
Acronym
Safety and efficacy of lower limb Neuromuscular Electrical Stimulation in persons with acute spinal cord injury
Scientific Title
Safety and efficacy of lower limb Neuromuscular Electrical Stimulation in persons with acute spinal cord injury
Scientific Title:Acronym
Safety and efficacy of lower limb Neuromuscular Electrical Stimulation in persons with acute spinal cord injury
Region
| Japan |
Condition
Condition
Patients with spinal cord injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the this study is the immediate effect of the Neuromuscular Electrical Stimulation in patients with acute spinal cord injury
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in quadriceps muscle thickness
Key secondary outcomes
Amount of change in quadriceps muscle strength
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Standard Physical Therapy and Neuromuscular Electrical Stimulation (2 weeks, 5 days a week, 40 minutes a day, 50 Hz, 300 s, 15-40 mA)
Interventions/Control_2
Standard Physical Therapy
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with AIS C and D incomplete cervical spinal cord injuries admitted within 1 day of injury
Key exclusion criteria
If you have a pelvic or femoral fracture, If complications affecting muscle strength are observed, If adverse events are observed along the way
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Morooka |
Organization
Saitama Medical University Faculty of Health
Division name
Department of Physical Therapy
Zip code
350-0496
Address
Moroyama-cho Iruma-gun, Saitama 981 Kawakado
TEL
049-295-1001
morooka@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Morooka |
Organization
Saitama Medical University Faculty of Health
Division name
Department of Physical Therapy
Zip code
350-0496
Address
Moroyama-cho Iruma-gun, Saitama 981 Kawakado
TEL
049-295-1001
Homepage URL
morooka@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Faculty of Health
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University Faculty of Health
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 Committee of Saitama Medical Center
Address
Kawagoe, Saitama 1981 Kamoda
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 | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046457
Publication of results
Unpublished
Result
URL related to results and publications
http://jsnpt20.umin.jp/images/gene_abstractbook.pdf
Number of participants that the trial has enrolled
49
Results
The relative differences between the initial and final results were -25.7% and -26.0% for the higher and lower sides, respectively, in the control group and -14.2% and -15.1%, respectively, in the NMES group, with significantly fewer reductions in both sides in the NMES group. The initial and final changes for the higher and lower sides were 0.4 and 0.4, respectively, in the control group and 0.8 and 1.3, respectively, in the NMES group, showing significant improvement in the lower side in the NMES group.
Results date posted
| 2024 | Year | 01 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant (control and NMES groups) were age (67.7, 64.9 years), Sex (20 male/5 female, 19 male/5 female), BMI (23.5,23.2), AIS (13 C/12 D, 13 C/11 D), and injury mechanism (11 fall on level surface/fall 6/traffic accident 2/Other 6, 12 falls on level surface/fall 2/traffic accident 6/Other 4).
Participant flow
The study participants comprised consecutively enrolled individuals aged <90 years with cervical SCI classified as AIS grades C and D who were admitted to an acute care hospital within 48 hours of injury between February 2021 and March 2022. A total of 104 individuals were eligible during the study period. Excluding 39 of them who met the exclusion criteria. Sixty-five individuals who met the inclusion criteria were stratified according to the AIS grade and were randomly assigned to the control group (n=33) or the NMES group (n=32). During the study, 6 individuals in the control group were discharged or transferred early, 1 underwent reoperation, and 1 had a sudden change in condition. In the NMES group, 6 individuals were discharged or transferred early, and 2 developed delirium, all of whom were not followed up. One participant was assigned to the NMES group but did not receive NMES due to pre-existing dermatitis. However, he was analyzed as the NMES group according to the modified ITT analysis.
The final analysis included 25 and 24 individuals in the control and NMES groups, respectively.
Adverse events
No adverse events related to NMES, such as skin rash, myalgia, or discomfort during the procedure, occurred in the NMES group.
Outcome measures
The primary endpoints were the thicknesses of the rectus femoris and vastus medialis muscles and the L3 value of the LEMS. L3 motor function was evaluated on a 6-point scale from 0 to 5 points; the side with the higher value was the higher side, and the side with the lower value was the lower side.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 04 | Day |
Last modified on
| 2024 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046457
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