UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028653 |
|---|---|
| Receipt number | R000032789 |
| Scientific Title | The effect of Honda walking assist on walking in patients with Parkinson's disease |
| Date of disclosure of the study information | 2017/08/14 |
| Last modified on | 2017/08/13 22:52:00 |
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Basic information
Public title
The effect of Honda walking assist on walking in patients with Parkinson's disease
Acronym
The effect of Honda walking assist on walking in patients with Parkinson's disease
Scientific Title
The effect of Honda walking assist on walking in patients with Parkinson's disease
Scientific Title:Acronym
The effect of Honda walking assist on walking in patients with 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 clarify the efficacy of a wearable exoskeleton stride management assist device, Honda Walking Assist (HWA: Honda R and D Corporation, Japan) on gait and rehabilitation in Parkinson's disease (PD) patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The direct effect study: Patients did 10 meters and 3 minutes walking wearing HWA with and without stride assist six times on separate days. We estimated the velocity and step length in 10 m walking, and distance and step length in 3 min walking.
2. The indirect effect study: Patients did step and walking rehabilitation for 30 min, 4 times / 3 weeks without HWA (phase A1) , using HWA (phase B1), without HWA (phase A2) and using HWA (phase B2). We evaluated the velocity and step length in 10 m walking, and distance and step length in 3 min walking, without HWA at the pre-intervention and each post-phase.
Key secondary outcomes
Berg Balance Scale(BBS), UPDRS(Part3), MDS-UPDRS 3.11(freezing of gait), Freezing of gait questionnaire(FOG-Q) in the indirect effect study.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The direct effect study: Patients did 10 meters and 3 minutes walking wearing HWA with and without stride assist six times on separate days. We estimated the velocity and step length in 10 m walking, and distance and step length in 3 min walking.
The indirect effect study: Patients did step and walking rehabilitation for 30 min, 4 times / 3 weeks without HWA (phase A1) , using HWA (phase B1), without HWA (phase A2) and using HWA (phase B2). We evaluated the velocity and step length in 10 m walking, and distance and step length in 3 min walking, without HWA at the pre-intervention and each post-phase.
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Parkinson's disease
Having the ability to walk independently with/without canes or a walker
Having gait disorders associated with Parkinson's disease
Key exclusion criteria
Dementia
No ability to to walk independently with/without canes or a walker
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriko Kawashima |
Organization
Kawashima Neurology Clinic
Division name
Neurology
Zip code
Address
5-13-17, Kugenuma-Matsugaoka, Fujisawa, Japan
TEL
0466-55-1358
nkawashi@pf7.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Kawashima |
Organization
Kawashima Neurology Clinic
Division name
Neurology
Zip code
Address
5-13-17, Kugenuma-Matsugaoka, Fujisawa, Japan
TEL
0466-55-1358
Homepage URL
nkawashi@pf7.so-net.ne.jp
Sponsor or person
Institute
Kawashima Neurology Clinic
Institute
Department
Personal name
Funding Source
Organization
Kawashima Neurology Clinic
Organization
Division
Category of Funding Organization
Self funding
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
かわしま神経内科クリニック（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 14 | 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
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
| 2016 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 13 | Day |
Last modified on
| 2017 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032789
