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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017185
Receipt No. R000019891
Scientific Title The functional gait recovery with transcutaneous spinal afferent stimulation among patients with stroke
Date of disclosure of the study information 2015/04/27
Last modified on 2019/05/26

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Basic information
Public title The functional gait recovery with transcutaneous spinal afferent stimulation among patients with stroke
Acronym Spinal stimulation for stroke
Scientific Title The functional gait recovery with transcutaneous spinal afferent stimulation among patients with stroke
Scientific Title:Acronym Spinal stimulation for stroke
Region
Japan

Condition
Condition stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess the efficacy of spinal stimulation for functional gait recovery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes 10m Walk speed
Key secondary outcomes Gait analysis
Electrophysiological study
Imaging

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Transcutaneous spinal afferent stimulation
(TSAS) + hipstimulation + treadmill gait training
Interventions/Control_2 TSAS + treadmill gait training
Interventions/Control_3 treadmill gait training
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 Time from stroke onset is over 5 months
No cog nitive impairment
Position sense of lower extremity is scored 1 or more with SIAS
Half sitting is scored 5 or more with FIM like scale
SIAS hip flexion test is 1 or more
SIAS knee extension test is 1 or more
Key exclusion criteria Severe cardiac disease
Uncontrolled hypertension
Acute illness and fever
Recent medical history of pulmonary embolism,acute corpulmonale, and severe pulmonary hypertension
Severe liver failure and renal failure
Orthopedic complication, preventing exercise
Severe cog nitive impairment and mental illness
Other metabolic disease
Patients with contraindication of electrical therapy
Pace maker user
Patients with shunt or clipping .
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Toshiyuki
Middle name
Last name Fujiwara
Organization Juntendo University
Division name Rehabilitation Medicine
Zip code 113-8421
Address 2-1-1 Hongo, Bunkyo, Tokyo
TEL 03-3813-3111
Email t-fujiwara@juntendo.ac.jp

Public contact
Name of contact person
1st name Toshiyuki
Middle name
Last name Fujiwara
Organization Juntendo University
Division name Rehabilitation Medicine
Zip code 113-8421
Address 2-1-1 Hongo, Bunkyo, Tokyo
TEL 03-3813-3111
Homepage URL
Email t-fujiwara@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization none
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 Juntendo Hospital Certified Review Board
Address 3-1-3,Hongo,Bunkyo-ku,Tokyo 113-8431 Tokyo
Tel 0 3 -5 8 0 2 -1 5 8 4
Email crbjun@ juntendo.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 jRCTs032180289
Org. issuing International ID_1 jRCT
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 27 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 Enrolling by invitation
Date of protocol fixation
2014 Year 09 Month 09 Day
Date of IRB
2019 Year 03 Month 11 Day
Anticipated trial start date
2019 Year 05 Month 27 Day
Last follow-up date
2021 Year 04 Month 30 Day
Date of closure to data entry
2021 Year 06 Month 30 Day
Date trial data considered complete
2021 Year 08 Month 31 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information The protocol of this study was changed and approved at 11 March 2019

Management information
Registered date
2015 Year 04 Month 20 Day
Last modified on
2019 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019891

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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