UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030950 |
|---|---|
| Receipt number | R000035339 |
| Scientific Title | Feasibility and safety test of functional therapy by robot suit HAL for motor function disorder in children |
| Date of disclosure of the study information | 2018/01/23 |
| Last modified on | 2024/01/28 09:04:00 |
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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
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
hkamada@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
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
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
in the process of organizing
Publication of results
Unpublished
Result
URL related to results and publications
in the process of organizing
Number of participants that the trial has enrolled
2
Results
in the process of organizing
Results date posted
| 2023 | Year | 01 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
in the process of organizing
Participant flow
in the process of organizing
Adverse events
in the process of organizing
Outcome measures
in the process of organizing
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
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
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment of participants has been closed.
Management information
Registered date
| 2018 | Year | 01 | Month | 23 | Day |
Last modified on
| 2024 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035339
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
