UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Peripheral neuromodulotor prior to rehabilitation intervention on motor recovery after cervical spinal cord injury and the neural basis
Acronym	Neurorehabilitation of cervical spinal cord injury
Scientific Title	Effects of Peripheral neuromodulotor prior to rehabilitation intervention on motor recovery after cervical spinal cord injury and the neural basis
Scientific Title:Acronym	Neurorehabilitation of upper motor recovery after cervical spinal cord injury
Region	Japan

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

Objectives
Narrative objectives1	To investigate whether neuromodulators at the periphery prior to physical intervention would b e effective for improving upper extremity paresi s after cervical spinal cord injury and to explore the underlying mechanism of motor recovery us ing near infrared spectroscopy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ASIA motor scale
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	neuromodulators prior to physical therapy
Interventions/Control_2	physical therapy only
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1)age ranging 20 to 80 2)within 1 month of injury onset 3)severe key muscles disabilities of upper extremity correspond to MMT 1-2/5 4)conscious alert 5)sound cognition 6)stable physical state 7)normal blood pressure 8)no fracture of target extremities
Key exclusion criteria	unconsciousness dementia psychiatric disorder or mental disorders epilepsy unstable physical state metal implantation including Pace maker severe arhythmia or sever CHF myogenic diseases
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Shigeru Middle name Last name Obayashi
Organization	Saitama medical center Saitama medical university
Division name	department of rehabilitation medicine
Zip code	350-8550
Address	1981 kamoda kawagoe-city, saitama, Japan
TEL	049-228-3529
Email	ohbayash@saitama-med.ac.jp

Public contact
Name of contact person	1st name Shigeru Middle name Last name Obayash
Organization	Saitama medical center Saitama medical university
Division name	department of rehabilitation medicine
Zip code	350-8550
Address	1981 kamoda kawagoe-city, saitama, Japan
TEL	049-228-3529
Homepage URL
Email	ohbayash@saitama-med.ac.jp

Sponsor
Institute	saitama medical university
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Saitama medical center Saitama medical university
Address	1981 kamoda kawagoe-city, saitama, Japan
Tel	049-228-3529
Email	ohbayash@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	埼玉医科大学総合医療センター（埼玉県）

Other administrative information
Date of disclosure of the study information	2022 Year 02 Month 03 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	Preinitiation
Date of protocol fixation	2022 Year 02 Month 03 Day
Date of IRB
Anticipated trial start date	2022 Year 02 Month 03 Day
Last follow-up date	2025 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	2022 Year 02 Month 03 Day
Last modified on	2022 Year 02 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053418