UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021907 |
|---|---|
| Receipt number | R000025262 |
| Scientific Title | Studies on rehabilitation for patients with chronic spinal cord injury using robot suits called Hybrid Assistive Limb (HAL) |
| Date of disclosure of the study information | 2016/04/15 |
| Last modified on | 2019/04/16 12:21:56 |
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Basic information
Public title
Studies on rehabilitation for patients with chronic spinal cord injury using robot suits called Hybrid Assistive Limb (HAL)
Acronym
Studies on rehabilitation using robot suits called Hybrid Assistive Limb (HAL)
Scientific Title
Studies on rehabilitation for patients with chronic spinal cord injury using robot suits called Hybrid Assistive Limb (HAL)
Scientific Title:Acronym
Studies on rehabilitation using robot suits called Hybrid Assistive Limb (HAL)
Region
| Japan |
Condition
Condition
Patients with chronic spinal cord injury and postoperative patients with spinal cord diseases.
Classification by specialty
| Orthopedics | Radiology | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effectiveness of neuro-rehabilitation using HAL on patients with chronic spinal cord injury and postoperative patients with spinal cord diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1)Motor function evaluation: score the motor function using ASIA score,
in addition measure the skeletal muscle mass index
2)Walking ability,sense of equilibrium : using Barthal index,2 minutes walk test , 10m walking test, Time up and go test , and Berg Balance Scale.
3)Sensory function evaluation : score the motor function using ASIA score
4)Resting-state functional MRI (Rs-fMRI): Analyze the brain connectivity in patients using fMRI, and to analyze the correlation of brain connectivity and motor function recovery.
Key secondary outcomes
Questionnaire survey: SF-36, VAS index, PainDETECT, degree of satisfaction, Clinical Global Impression.
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
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
neuro-rehabilitation using HAL
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Satisfy the following conditions
1.age:20-75 years old
2.The patients with chronic spinal cord injury(over 6 month after injury) or the postoperative patients with spinal cord disease(over 6 month after operation),who reached the plateau of the functional recovery.
3.The patients who have more than 1 score in manual test of lower limbs and can't walk by themselves.
4.The patients were informed about their disease and received the explanation about using HAL and outcome evaluation. In addition, the patients agree to perform the neuro-rehabilitation using HAL.
Key exclusion criteria
Poor general condition due to SCI
Difficult to take fMRI
No informed consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Nakamura |
Organization
Keio University School of Medicine
Division name
Orthopaedic surgery
Zip code
1608582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3809
masa@keio.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Nakamura |
Organization
Keio University School of Medicine
Division name
Orthopaedic surgery
Zip code
1608582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3809
Homepage URL
masa@a8.keio.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Keio University School of Medicine, Tokyo JAPAN
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
The Uehara Memorial foundation
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
IRB committee of Keio University School of Medicine
Address
35 Shinanomachi Shinjuku
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
慶応義塾大学医学部/慶応義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 15 | 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
20
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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2019 | 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
| 2016 | Year | 04 | Month | 14 | Day |
Last modified on
| 2019 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025262
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