UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026632 |
|---|---|
| Receipt number | R000030517 |
| Scientific Title | Effects of orthotic therapeutic electrical stimulation in the treatment of patients with paresis associated with acute cervical spinal cord injury |
| Date of disclosure of the study information | 2017/03/24 |
| Last modified on | 2017/03/21 18:27:12 |
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Basic information
Public title
Effects of orthotic therapeutic electrical stimulation in the treatment of patients with paresis associated with acute cervical spinal cord injury
Acronym
Effects of orthotic therapeutic electrical stimulation in the treatment of patients with paresis associated with acute cervical spinal cord injury
Scientific Title
Effects of orthotic therapeutic electrical stimulation in the treatment of patients with paresis associated with acute cervical spinal cord injury
Scientific Title:Acronym
Effects of orthotic therapeutic electrical stimulation in the treatment of patients with paresis associated with acute cervical spinal cord injury
Region
| Japan |
Condition
Condition
Acute cervical spinal cord injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to use orthotic therapeutic electrical stimulation (TES) for the treatment of patients with paresis associated with acute cervical spinal cord injury, and to examine the effects of the treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The evaluation items consisted of the total passive motion (TPM) of fingers ; and data was collected over time, namely at one week, one month, and three months after injury. For the TPM of the fingers, the total passive motion was measured separately on the right side and on the left side on the basis of the flexion-extension range of motion in the MP, PIP and DIP joints of the first finger to the fifth finger (14 joints, 28 motions: 1420 Deg in total).
Key secondary outcomes
The upper limb ASIA motor score and the edema.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Between May 2011 and December 2014
Among the 134 patients who were admitted to our hospital within one week of injury, 43 patients had spinal injuries classified as grades B or C according to the Frankel classification. From among those selected, 4 patients with dementia and mental illness and 2 patients with respiratory failure were excluded; and the remaining 37 patients were randomly assigned to each group. Eight patients were transferred to other hospitals within 3 months after admission because of an aggravation of their general condition; and as a result, the total number of patients who could be subjected to measurements for 3 months or longer was 29 . The TES group was composed of 15 patients (15 males, mean age: 57.7+-16.9 years).
For the TES training, the training time was as follows: 5 minutes twice daily after an evaluation 1 week after injury; 10 minutes twice daily at 2 weeks after injury; 15 minutes twice daily at 3 weeks after injury; and 20 minutes twice daily at 4 weeks after injury and thereafter. Finger extension and flexion movements were induced within a range in which there was no stimulus-induced pain.
Interventions/Control_2
The control group was composed of 14 patients (13 males and one female, mean age: 59.4+-18.5 years).
The control group underwent conventional training alone.
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
| 15 | years-old | <= |
Age-upper limit
| 76 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Acute cervical spinal injuries classified as grades B and C according to the Frankel grading system.
Key exclusion criteria
Those with spinal injuries classified as grades A, D and E according to the Frankel grading system were excluded. In addition, the following were also considered as exclusion criteria for TES: patients with dementia, mental illness, patients wearing ventilators, and patients with injury to the fingers or forearms.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Iwahashi |
Organization
Japan Organization of Occupational Health and Safety, Spinal Injuries Center, Fukuoka, Japan
Division name
Rehabilitation
Zip code
Address
Igisu 550-4, Iizuka city, Fukuoka 820-8508, Japan
TEL
0948-24-7500
yakyumancity@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Iwahashi |
Organization
Japan Organization of Occupational Health and Safety, Spinal Injuries Center, Fukuoka, Japan
Division name
Rehabilitation
Zip code
Address
Igisu 550-4, Iizuka city, Fukuoka 820-8508, Japan
TEL
0948-24-7500
Homepage URL
yakyumancity@yahoo.co.jp
Sponsor or person
Institute
Japan Organization of Occupational Health and Safety, Spinal Injuries Center, Fukuoka, Japan
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
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
労働者健康安全機構 総合せき損センター(福岡)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 24 | 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
| 2011 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 27 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 27 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 21 | Day |
Last modified on
| 2017 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030517
