UMIN-CTR Clinical Trial

Basic information
Public title	Gait Training using Honda Walking Assist for Parkinson's disease
Acronym	HWATPD
Scientific Title	Stride Management Assist Gait Training for Parkinson's Disease: An Open-Label, Randomized Controlled Study
Scientific Title:Acronym	SMATPD
Region	Japan

Condition
Condition	Parkinson's Disease
Classification by specialty	Neurology Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the efficacy of gait training using a wearable exoskeleton stride management assist (SMA: Honda R and D Corporation, Japan) in moderately advanced Parkinson's disease (PD) patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Primary outcome is walking distance in 3-Minute Walk Test (3MWT). We measure it at baseline and at post-intervention of 10 sessions for 3 months.
Key secondary outcomes	Secondary outcomes are 10-Meter Walk Test, physiological cost index (PCI) in 3MWT, Berg Balance Scale, Functional Reach Test, UPDRS part III, MDS-UPDRS 3.11 (freezing of gait), Freezing of Gait Questionnaire, PDQ-39, EQ-5D-5L and gait and posture analysis using Mobile Motion Visualizer. We measure them at baseline and at post-intervention of 10 sessions for 3 months.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Patients undergo over-ground gait training using SMA of 30 minutes per session, ten times for 3 months outdoors near the participants' home.
Interventions/Control_2	Patients undergo over-ground gait training of 30 minutes per session, ten times for 3 months near the participants' home.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	We include out-patients with PD fulfilled MDS clinically established PD criteria, who are able to walk independently with/without walking aides and patients have the following conditions; 1. Hoehn and Yahr stage is 2-4 degrees in on state, 2. UPDRS Part III score is 10 points or more in on state, 3. MMSE score is not lower than 26 points, and 4. The patient does not show an unpredictable off state.
Key exclusion criteria	We exclude out-patients with PD fulfilled MDS clinically established PD criteria, who are unable to walk with walking aids, or patients who have the following conditions; 1. Hoehn and Yahr stage is 1 or 5 degrees in on state. 2. UPDRS Part III score is below 10 points in on state, 3. MMSE score is below 26 points, or 4. The patient shows an unpredictable off state.
Target sample size	14

Research contact person
Name of lead principal investigator	1st name Noriko Middle name Last name Kawashima
Organization	Kawashima Neurology Clinic
Division name	Neurology
Zip code	251-0038
Address	5-13-17, Kugenuma-Matsugaoka, Fujisawa, Kanagawa
TEL	81-466-55-1358
Email	nkawashi@pf7.so-net.ne.jp

Public contact
Name of contact person	1st name Noriko Middle name Last name Kawashima
Organization	Kawashima Neurology Clinic
Division name	Neurology
Zip code	251-0038
Address	5-13-17, Kugenuma-Matsugaoka, Fujisawa, Kanagawa
TEL	81-466-55-1358
Homepage URL
Email	nkawashi@pf7.so-net.ne.jp

Sponsor
Institute	Kawashima Neurology Clinic
Institute
Department

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	Ethics Committee, National Sagamihara Hospital
Address	18-1, Sakuradai, Sagamihara, Kanagawa
Tel	+81-42-742-8311
Email	222-rinri@mail.hosp.go.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	かわしま神経内科クリニック/Kawashima Neurology Clinic (Kanagawa)

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 11 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	Completed
Date of protocol fixation	2017 Year 09 Month 28 Day
Date of IRB	2017 Year 09 Month 28 Day
Anticipated trial start date	2017 Year 10 Month 20 Day
Last follow-up date	2021 Year 11 Month 10 Day
Date of closure to data entry	2021 Year 11 Month 10 Day
Date trial data considered complete	2021 Year 11 Month 10 Day
Date analysis concluded	2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 04 Month 11 Day
Last modified on	2022 Year 01 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045721