UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of orthotic therapeutic electrical stimulation in the treatment of patients with paresis associated with acute cervical spinal cord injury
Title of the study (Brief title)	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	Kenji Iwahashi
Organization	Japan Organization of Occupational Health and Safety, Spinal Injuries Center, Fukuoka, Japan
Division name	Rehabilitation
Address	Igisu 550-4, Iizuka city, Fukuoka 820-8508, Japan
TEL	0948-24-7500
Email	yakyumancity@yahoo.co.jp

Public contact
Name of contact person	Kenji Iwahashi
Organization	Japan Organization of Occupational Health and Safety, Spinal Injuries Center, Fukuoka, Japan
Division name	Rehabilitation
Address	Igisu 550-4, Iizuka city, Fukuoka 820-8508, Japan
TEL	0948-24-7500
Homepage URL
Email	yakyumancity@yahoo.co.jp

Sponsor
Institute	Japan Organization of Occupational Health and Safety, Spinal Injuries Center, Fukuoka, Japan
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 04 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030517