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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000030950 |
Receipt No. | 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 | 2021/01/09 |
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 |
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Condition | |||
Condition | Cerebral palsy / spina bifida / cranial nerve disease / spinal cord disease | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 35 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |