UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019559 |
|---|---|
| Receipt number | R000022508 |
| Scientific Title | Research for effectiveness on walking ability of patients with impairment of low extremities by robot-suit "HAL" |
| Date of disclosure of the study information | 2015/10/29 |
| Last modified on | 2017/05/01 15:45:01 |
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Basic information
Public title
Research for effectiveness on walking ability of patients with impairment of low extremities by robot-suit "HAL"
Acronym
effectiveness on walking ability by robot-suit "HAL"
Scientific Title
Research for effectiveness on walking ability of patients with impairment of low extremities by robot-suit "HAL"
Scientific Title:Acronym
effectiveness on walking ability by robot-suit "HAL"
Region
| Japan |
Condition
Condition
impairment of low extremities
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate whether stand up and walk ability of patients with impairment of low extremities improve or not by robot-suit "HAL".
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Two times a week rehabilitation were performed for 5 weeks.
We evaluate stand up and walk ability at the end of 5 weeks rehabilitation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
We investigate whether rehabilitation using robot suit HAL(Cyberdyne) for patients with chronic impairment of low extremities results in their functional improvement or not.
Two times (30-40 mins) a week rehabilitation were performed for 5 weeks.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
chronic impairment of low extremities
possible to stand up with assistance
possible to sit
weight under 80kg
height 145cm - 185cm
obtained informed consent for the study
Key exclusion criteria
severe joint disorders
dementia unable to obey instructions from therapists
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuo Kobayashi |
Organization
National Defense Medical College
Division name
Rehabilitation
Zip code
Address
3-2, Namiki, Tokorozawa
TEL
04-2995-1511
tkobayas@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuo Kobayashi |
Organization
National Defense Medical College
Division name
Rehabilitation
Zip code
Address
3-2, Namiki, Tokorozawa
TEL
04-2995-1511
Homepage URL
tkobayas@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
防衛医科大学校
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
It took several time exercises to accustomed to the use of "HAL".
In possible gait group patients with abnormal walking patterns got improvement, but patients with weak muscle strength owing to their disease could not get improvement.
In impossible gait group some patients could not continue rehabilitation exercise owing to their low stamina. The patient who could walk using "HAL" need to use bilateral side canes.
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
| 2011 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 29 | Day |
Last modified on
| 2017 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022508
