UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039642 |
|---|---|
| Receipt number | R000045210 |
| Scientific Title | Influence of overground walking training using a Body Weight Support walker on the walking speed of hemiplegic stroke patients |
| Date of disclosure of the study information | 2020/03/02 |
| Last modified on | 2021/09/20 16:39:38 |
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Basic information
Public title
Influence of walking training using a Body Weight Support walker on walking speed of hemiplegic stroke patients
Acronym
Influence of walking training using a Body Weight Support walker on walking speed of hemiplegic stroke patients
Scientific Title
Influence of overground walking training using a Body Weight Support walker on the walking speed of hemiplegic stroke patients
Scientific Title:Acronym
Influence of overground walking training using a Body Weight Support walker on the walking speed of stroke patients
Region
| Japan |
Condition
Condition
Hemiplegic patients after stroke
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the Influence of walking training using a Body Weight Support (BWS) walker on walking speed in hemiplegic patients after stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Walking Speed(Comfortable Walking Speed, Maximum Walking Speed)
Measurements are taken before and after each of normal walking training, 0% BWS walking training using a BWS walker, and 20% BWS walking training using a BWS walker.
Key secondary outcomes
Gait Symmetry (Symmetry ratio), Gait Variability(Coefficient of Variation:CV), Step Length, Stride Length, Cadence, Stance Time, Swing Time, Double Support Time
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Perform normal walking training for 10 minutes a day.
Interventions/Control_2
Perform walking training with 0% BWS using a BWS walker for 10 minutes a day.
Interventions/Control_3
Perform walking training with 20% BWS using a BWS walker for 10 minutes a day.
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.Subjects with developed hemiplegia after the first stroke.
2.Subjects with can walk without assistance.(Functional Ambulation Category of 3 points or more)
Key exclusion criteria
1.Subjects with impaired consciousness. (Japan Coma Scale of 3 or more)
2.Subjects with cognitive decline(Mini Mental State Examination 20 points or less), severe aphasic symptoms, higher brain dysfunction that are difficult to understand in this study.
3. Subjects who are unable to walk before the onset of stroke.
4.Subjects with cardiovascular or respiratory disease that limit training.
5.Subjects with lower limb osteoarthritis that limit training.
6.Subjects with pain in harness or suspension.
7.Subjects with body weighing more than 100 kg.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Taishi |
| Middle name | |
| Last name | Kikkawa |
Organization
Ushioda General Hospital
Division name
Department of Rehabilitation
Zip code
230-0001
Address
1-6-20 Yako,Turumi,Yokohama,Kanagawa,Japan
TEL
045-574-1011
mrcl.kikkawa@gmail.com
Public contact
Name of contact person
| 1st name | Taishi |
| Middle name | |
| Last name | Kikkawa |
Organization
Ushioda General Hospital
Division name
Department of Rehabilitation
Zip code
230-0001
Address
1-6-20 Yako,Turumi,Yokohama,Kanagawa,Japan
TEL
045-574-1011
Homepage URL
mrcl.kikkawa@gmail.com
Sponsor or person
Institute
Ushioda General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
KANAGAWA UNIVERSITY of HUMAN SERVICES
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KANAGAWA UNIVERSITY of HUMAN SERVICES
Address
1-10-1 Heisei,Yokosuka,Kanagawa,Japan
Tel
046-828-2530
kenkyuurinri@kuhs.ac.jp
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
| 2020 | Year | 03 | Month | 02 | 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
23
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
| 2020 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 28 | Day |
Last modified on
| 2021 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045210
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