UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040131 |
|---|---|
| Receipt number | R000045721 |
| Scientific Title | Stride Management Assist Gait Training for Parkinson's Disease: An Open-Label, Randomized Controlled Study |
| Date of disclosure of the study information | 2020/04/11 |
| Last modified on | 2022/01/05 15:50:26 |
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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
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
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
Ethics Committee, National Sagamihara Hospital
Address
18-1, Sakuradai, Sagamihara, Kanagawa
Tel
+81-42-742-8311
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045721
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| Registered date | File name |
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