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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039240
Receipt No. 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

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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
Email 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
Email eiichi@hirosaki-u.ac.jp

Sponsor
Institute Dept of Rehabilitation Medicine, Hirosaki University, Graduate school of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044742

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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