UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility and safety test of functional therapy by robot suit HAL for motor function disorder in children
Acronym	Feasibility and safety test of robot suit HAL in children
Scientific Title	Feasibility and safety test of functional therapy by robot suit HAL for motor function disorder in children
Scientific Title:Acronym	Feasibility and safety test of robot suit HAL in children
Region	Japan

Condition
Condition	Cerebral palsy / spina bifida / cranial nerve disease / spinal cord disease
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this research, we will conduct feasibility and safety tests for establishing HAL treatment programs centered on walking for children with cerebral palsy and neuromuscular disease.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adverse event Malfunction of HAL and accessory equipment Feasibility of rehabilitation
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	rehabilitation
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. A patient who can consent to a document by himself or his / her family. A substitute person is necessary. 2. Patient capable of wearing HAL. 3. During the study period, patients who can continue hospitalization or outpatient visits according to the study schedule.
Key exclusion criteria	1. Patients who have difficulty in voluntary limb activity according to instructions due to consciousness disturbance or severe dementia. 2. Patients who are severely deformed in the skeletal system such as osteoarthritis, degenerative spondylosis, scoliosis, and are difficult to train including joint movement. Patient who is difficult to wear HAL. 3. Patients who have complications such as bleeding tendency or osteoporosis which are problems in training. 4. Patients who can not affix HAL biomedical electrodes due to skin diseases. 5. Patients who participated in other research within 12 weeks of this clinical study. 6. Clinical trial Patients who are judged to be inappropriate for participation in this study by a physician or shared medical doctor.
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name KAMADA
Organization	University of Tsukuba Hospital
Division name	Department of Orthopaedics surgery
Zip code	305-8575
Address	2-1-1 Amakubo Tsukuba
TEL	029-853-3219
Email	hkamada@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name KAMADA
Organization	University of Tsukuba Hospital
Division name	Department of Orthopaedics surgery
Zip code	305-8575
Address	2-1-1 Amakubo Tsukuba
TEL	029-853-3219
Homepage URL
Email	hkamada@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba Hospital
Institute
Department

Funding Source
Organization	University of Tsukuba Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	University of Tsukuba hospital
Address	2-1-1 Amakubo Tsukuba
Tel	029-853-3900
Email	seikei@md.tsukuba.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	2018 Year 01 Month 23 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	Enrolling by invitation
Date of protocol fixation	2018 Year 01 Month 23 Day
Date of IRB	2019 Year 01 Month 31 Day
Anticipated trial start date	2018 Year 02 Month 17 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 23 Day
Last modified on	2020 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035339

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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