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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000028017 |
Receipt No. | R000032078 |
Scientific Title | Study to evaluate effects of robot suit HAL in combination with acupuncture treatment |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2018/02/20 |
Basic information | ||
Public title | Study to evaluate effects of robot suit HAL in combination with acupuncture treatment | |
Acronym | Study to evaluate effects of robot suit HAL in combination with acupuncture treatment | |
Scientific Title | Study to evaluate effects of robot suit HAL in combination with acupuncture treatment | |
Scientific Title:Acronym | Study to evaluate effects of robot suit HAL in combination with acupuncture treatment | |
Region |
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Condition | ||
Condition | Movement disorder | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The purpose of this research is to contribute to restoration of motor function by rehabilitation using HAL, in combination with acupuncture or moxibustion treatment to reduce spasm and flaccid of muscle that interfere with walking training. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Barthel Index |
Key secondary outcomes | 1.Brunnstrom stage
2.Fugl-Meyer Assessment 3.Modified Ashworth Scale 4.10m walking test 5.chair-stand test 6.Functional Independence Measure 7.VAS 8.Subjective walking evaluation 9.Myogenic Potential Measuring Apparatus 10.fNIRS |
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 | Acupuncture treatment
Exercise training using HAL |
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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 | Patients with lower limb motor paralysis who have good conscious state and stable state of the whole body, and can judge safety, danger etc. | |||
Key exclusion criteria | 1. Significant lower limb joint disability (strong deformation, inflammation, dislocation, etc.)
2. Cardiac pacemaker wearer, Pregnant 3. Higher brain dysfunction, dementia, severe sensory disorder 4. Difficult to hold the sitting posture 5. Do not fit the size of HAL 6. Abdominal pressure difficulty 7. Judged by doctors not to be applied |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Suzuka University of Medical Science | ||||||
Division name | Institute of Traditional Chinese Medicine | ||||||
Zip code | |||||||
Address | 1275-3, Kishioka,Suzuka-city, Mie, JAPAN | ||||||
TEL | 059-381-2385 | ||||||
ko-n@suzuka-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Suzuka University of Medical Science | ||||||
Division name | Institute of Traditional Chinese Medicine | ||||||
Zip code | |||||||
Address | 1275-3, Kishioka,Suzuka-city, Mie, JAPAN | ||||||
TEL | 059-381-2385 | ||||||
Homepage URL | |||||||
takagi17@suzuka-u.ac.jp |
Sponsor | |
Institute | Suzuka University of Medical Science |
Institute | |
Department |
Funding Source | |
Organization | None |
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) | |
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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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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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=R000032078 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |