UMIN-CTR Clinical Trial

Basic information
Public title	The effect of long term intervention using orthosis transforming sensory modality on gait in patiants with hemiparesis
Acronym	The effect of long term intervention using orthosis transforming sensory modality on gait in patiants with hemiparesis
Scientific Title	The effect of long term intervention using orthosis transforming sensory modality on gait in patiants with hemiparesis
Scientific Title:Acronym	The effect of long term intervention using orthosis transforming sensory modality on gait in patiants with hemiparesis
Region	Japan

Condition
Condition	patients with hemiparesis due to brain tumor or stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate utility of long term intervention using the orthosis transforming sensory modality in gait with hemiparesis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II,III

Assessment
Primary outcomes	gait speed, stride length, gait cycle time
Key secondary outcomes	kinematic data and kinetic data during gait

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The subjects wear the orthosis transforming sensory modality and received 30 minutes of locomotion training on a treadmill.The orthosis makes sound when load at the heel or the distal condyle of a fifth metatarsal bone on the paretic side in stance phase during gait is input.
Interventions/Control_2	The subjects do not wear the orthosis transforming sensory modality and received 30 minutes of locomotion training on a treadmill.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) unilateral cerebral lesions due to stroke or brain tumor confirmed by computed tomography or magnetic resonance imaging 2) the ability to follow verbal commands. 3) the first stroke over six monthes 4) the ability to walk for 30 minutes in which rest is taken
Key exclusion criteria	1)a history of orthopedic problems 2)diabetic peripheral neuropathy 3)brainstem or cerebellar lesions 4)unilateral spatial neglect
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shin-Ichi Izumi
Organization	Tohoku University
Division name	Graduate school of Biomedical Engineering
Zip code
Address	2-1 Seiryo-cho, Aoba-ku, Sendai, Japan
TEL	022-717-7338
Email	izumis@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yusuke Sekiguchi
Organization	Tohoku University
Division name	Department of Rehabilitation
Zip code
Address	1-1 Seiryo-cho, Aoba-ku, Sendai, Japan
TEL	022-717-7677
Homepage URL
Email	yusuke5547@yahoo.co.jp

Sponsor
Institute	Department of Physical Medicine and Rehabilitation,Tohoku University Graduate School of Medicine
Institute
Department

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

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2015 Year 09 Month 01 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	2015 Year 08 Month 15 Day
Date of IRB	2015 Year 10 Month 06 Day
Anticipated trial start date	2015 Year 10 Month 06 Day
Last follow-up date	2019 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 06 Month 26 Day
Last modified on	2021 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020945