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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034807
Receipt No. R000039696
Scientific Title The effect of gait adaptation on physical activity and fall risk in patients with hemiparesis
Date of disclosure of the study information 2018/12/31
Last modified on 2018/11/07

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Basic information
Public title The effect of gait adaptation on physical activity and fall risk in patients with hemiparesis
Acronym The effect of gait adaptation on physical activity and fall risk in patients with hemiparesis
Scientific Title The effect of gait adaptation on physical activity and fall risk in patients with hemiparesis
Scientific Title:Acronym The effect of gait adaptation on physical activity and fall risk in patients with hemiparesis
Region
Japan

Condition
Condition Patients with hemiparesis due to stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the relationship between gait adaptability and physical activity or fall risk in patients with hemiparesis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Giat speed, number of falls during 6-month, step count per day
Key secondary outcomes Kinematic and kinetic data during gait

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Stroke patients:
1) unilateral cerebral lesions due to stroke confirmed by computed tomography or magnetic resonance imaging
2) the ability to follow verbal commands
3) community-dwelling
4) Functional Independence Measure (FIM) Locomotion score more than 6
Healthy people:
1) the ability to follow verbal commands
2) community-dwelling
3) FIM Locomotion score more than 6
Key exclusion criteria Stroke patients:
1) a history of circulatory, respiratory, and/or orthopedic problems interfering with gait
2) Mini Mental State Examination (MMSE) lower than 24 points
3) Stroke Impairment Assessment Set (SIAS) Visuospatial item lower than 2
4) SIAS Speech item lower than 1B
Healthy people:
1) MMSE lower than 24points
2) SIAS Visuospatial item lower than 2
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin-Ichi Izumi
Organization Tohoku University
Division name Department of Physical Medicine and Rehabilitation
Zip code
Address 2-1 Seiryo-cho, Aoba-ku, Sendai
TEL 022-717-7338
Email izumis@bme.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keita Honda
Organization Tohoku University Hospital
Division name Department of Rehabilitation
Zip code
Address 1-1 Seiryo-cho, Aoba-ku, Sendai
TEL 022-717-7677
Homepage URL
Email keita.honda.d2@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology
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
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
2018 Year 12 Month 31 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
2018 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Research design: Prospective cohort study
Recruitment Methods: Poster in tohoku university and hospital
Outcomes: Gait data in the even and uneven ground, number of falls during 6-months, step counts per day

Management information
Registered date
2018 Year 11 Month 07 Day
Last modified on
2018 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039696

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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