UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019194 |
|---|---|
| Receipt number | R000022165 |
| Scientific Title | The efficacy and safety of Hybrid Assistive Limb (HAL) for the gait disturbance of Parkinson's disease. |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2015/10/01 11:36:54 |
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Basic information
Public title
The efficacy and safety of Hybrid Assistive Limb (HAL) for the gait disturbance of Parkinson's disease.
Acronym
The efficacy of HAL for the gait of Parkinson's disease.
Scientific Title
The efficacy and safety of Hybrid Assistive Limb (HAL) for the gait disturbance of Parkinson's disease.
Scientific Title:Acronym
The efficacy of HAL for the gait of Parkinson's disease.
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and the safety of HAL for the gait disturbance of Parkinson's disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MDS-UPDRS,freezing of gait questionnaire,FOG-Q
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. PD with gait disturbance
2. BW 40 100Kg Height 150 190cm
Key exclusion criteria
1. Severe autonomic dysfunction
2. Heart failure
3. Respiration failure
4. Severe comorbities
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Tsuboi |
Organization
Fukuoka University, School of Medicine
Division name
Neurology
Zip code
Address
7-45-1, Nanakuma, Jonan-ku, Fukuoka, 814-0180, JAPAN
TEL
092-801-1011
tsuboi@cis.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masa-aki Higuchi |
Organization
Fukuoka University School of Medicine
Division name
Neurology
Zip code
Address
7-45-1, Nanakuma, Jonan-ku, Fukuoka, 814-0180, JAPAN
TEL
092-801-1011
Homepage URL
mhigu@fukuoka-u.ac.jp
Sponsor or person
Institute
Department of Neurology, Fukuoka University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Neurology, Fukuoka University School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Neurosurgery, Fukuoka University School of Medicine
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
| 2015 | Year | 10 | Month | 01 | 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
| 2015 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The efficacy and the safety of HAL for the gait disturbance with Parkinson's disease.
Management information
Registered date
| 2015 | Year | 10 | Month | 01 | Day |
Last modified on
| 2015 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022165
