UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039240 |
|---|---|
| Receipt number | R000044742 |
| Scientific Title | Effects of gait training with a voluntary driven Wearable Cyborg, Hybrid Assistive Limb (HAL), in patients with neuromuscular disease |
| Date of disclosure of the study information | 2020/01/25 |
| Last modified on | 2020/07/27 10:40:50 |
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Basic information
Public title
Effects of gait training with a voluntary driven Wearable Cyborg, Hybrid Assistive Limb (HAL), in patients with neuromuscular disease
Acronym
Treatment with Hybrid Assistive Limb in patients with neuromuscular disease
Scientific Title
Effects of gait training with a voluntary driven Wearable Cyborg, Hybrid Assistive Limb (HAL), in patients with neuromuscular disease
Scientific Title:Acronym
Treatment with Hybrid Assistive Limb in patients with neuromuscular disease
Region
| Japan |
Condition
Condition
neuromuscular disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of HAL-supported gait training in patients with neuromuscular disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The parameters in 2-min walk test, a 10-m walk test, SF-36 questionnaire, and the Hospital Anxiety and Depression Scale (HADS) were measured before treatment, 1 month after treatment, and 6 months after treatment.
Key secondary outcomes
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
Gait training wearing HAL for 6 months. A single course of treatment included nine sessions of gait training for 4 weeks, and each patient completed two to four treatment courses.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients had para- or quadriparesis but were restricted only to those who were self-pedalable or walkable using a walker and had a sufficient stability of the trunk.
Key exclusion criteria
Patients with severe cardiovascular disease, or who cannot walk with assistance.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kazutomo |
| Middle name | |
| Last name | Miura |
Organization
Hirosaki University, graduate school of Medicine
Division name
Dept. of Rehabilitation Medicine
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki, AOMORI
TEL
0172-33-5111
miurak0993@aol.jp
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Tsuda |
Organization
Hirosaki University, Graduate School of Medicine
Division name
Dept. of Rehabilitation Medicine
Zip code
036-8562
Address
5 Saifu-cho, Hirosaki, AOMORI
TEL
0172-33-5111
Homepage URL
eiichi@hirosaki-u.ac.jp
Sponsor or person
Institute
Dept of Rehabilitation Medicine, Hirosaki University, Graduate school of Medicine
Institute
Department
Personal name
Funding Source
Organization
NA
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
Hirosaki University, Graduate School of Medicine
Address
5 Zaifu-cho, Hirosaki, AOMORI
Tel
0172-33-5111
rinri@hirosaki-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 23 | Day |
Last modified on
| 2020 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044742
