UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002067 |
|---|---|
| Receipt number | 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 23:01:20 |
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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
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
khase@sc.itc.keio.ac.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002519
