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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002067
Receipt No. R000002519
Scientific Title Effects of therapeutic gait training using a prosthesis in ambulatory hemiparetic patients
Date of disclosure of the study information 2009/06/11
Last modified on 2012/07/09

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Basic information
Public title Effects of therapeutic gait training using a prosthesis in ambulatory hemiparetic patients
Acronym Prosthetic gait training for hemiparetic patients
Scientific Title Effects of therapeutic gait training using a prosthesis in ambulatory hemiparetic patients
Scientific Title:Acronym Prosthetic gait training for hemiparetic patients
Region
Japan

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

Objectives
Narrative objectives1 To examine effects of hemiparetic gait training in which the patients have to walk with a prosthesis applied to the non-paretic leg.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Fore-aft components of ground reaction force in the braking and propulsive phase of gait cycle, Step length, stance time, Cadence, Maximum walking velocity
Key secondary outcomes Muscular activation pattern during gait, Berg balance scale, Standing sway

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Gait training using a prosthesis
Interventions/Control_2 Conventional gait training
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
40 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with hemiparesis 6 months after stroke and over 3 months of rehabilitation treatments.
2) SIAS-motor: 2-4 on hip and knee joint function.
3) SIAS-sensory: 2 or 3 on position sense.
4) Independent walking over 10 m without a cane and orthosis.
Key exclusion criteria 1) Patients with heart or lung disease influencing gait training.
2) Patients with orthopedic disease influencing gait training.
3) Cognitive (HDS-R<20) and communication (FIM-Comprehension<=5) problems that could hinder cooperation.
4) Patients with movement disorders before stroke onset.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimitaka Hase
Organization Keio University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address Shinano-machi 35, Shinjuku-ku, Tokyo, Japan.
TEL 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kimitaka Hase
Organization Keio University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address Shinano-machi 35, Shinjuku-ku, Tokyo, Japan.
TEL 03-3353-1211
Homepage URL
Email khase@sc.itc.keio.ac.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research (B)
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
2009 Year 06 Month 11 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 Open public recruiting
Date of protocol fixation
2009 Year 05 Month 21 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
2012 Year 03 Month 01 Day
Date analysis concluded
2012 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 06 Month 10 Day
Last modified on
2012 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002519

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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