UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Rehabilitation procedures construction for gait improvement of spinal cord injury patients
Title of the study (Brief title)	Rehabilitation procedures construction for gait improvement of spinal cord injury patients
Region	Japan

Condition
Condition	spinal cord injury
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	I improve gait posture of the spinal cord injury patient with the foot bottom sensory disturbance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Walking test [Under intervention]
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Biofeedback by the electrical stimulation
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1)Spinal cord injury(Frankle A or B). 2)After injury for not less than 1 year 3)65 years old or older
Key exclusion criteria	1)Patients with unstable cardiac status including 2)Patients unable to communicate with staff
Target sample size	10

Research contact person
Name of lead principal investigator	Rina Hosoda
Organization	Kochi Medical School hospital
Division name	Department of rehabilitation
Address	Kohasu, Oko-cho, Nankoku, Kochi 783-805, Japan
TEL	(088)880-2490
Email	jm-rina@kochi-u.ac.jp

Public contact
Name of contact person	Rina Hosoda
Organization	Kochi Medical School hospital
Division name	Department of rehabilitation
Address	Kohasu, Oko-cho, Nankoku, Kochi
TEL	(088)880-2490
Homepage URL
Email	jm-rina@kochi-u.ac.jp

Sponsor
Institute	Department of rehabilitation, Kochi Medical School Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 08 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 08 Day
Last modified on	2016 Year 07 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026591