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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name