UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021367 |
|---|---|
| Receipt number | R000024643 |
| Scientific Title | Evaluation on a robotic ankle-foot orthosis with the support of plantar flexion motion |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2016/03/06 20:35:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation on a robotic ankle-foot orthosis with the support of plantar flexion motion
Acronym
Robotic ankle-foot orthosis with plantar flexion support
Scientific Title
Evaluation on a robotic ankle-foot orthosis with the support of plantar flexion motion
Scientific Title:Acronym
Robotic ankle-foot orthosis with plantar flexion support
Region
| Japan |
Condition
Condition
Hemiparesis patients (right ankle) with stroke or other neurological diseases
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Performance evaluation of the robotic ankle-foot orthosis with plantar flexion support
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of body movement and EMG such as limbs, torso, and floor reaction force during walking with the the robotic AFO
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
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Supporting the plantar flexion motion by using the robotic ankle-foot orthosis
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- hemiparesis patients with stroke or other neurological diseases
- able to walk without AFO in a short distance
- Able to use AFO, such as double Klenzak ankle joint brace
- Up to 80kg weight, 26.5cm foot length
- No mental health problem, and sufficient to perform the experiment
Key exclusion criteria
- Any patients with spasticity and solid contraction interfere with keeping standing posture
- Patient with dizziness or blood pressure drop problems during the gait training
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Yamazaki |
Organization
University of Tsukuba
Division name
Department of Orthopaedics Surgery, Faculty of Medicine
Zip code
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
TEL
029-853-3219
masashiy@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Suzuki |
Organization
University of Tsukuba
Division name
Center for Cybernics Resaerch
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-5761
Homepage URL
kenji@ieee.org
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
Center for Cybernics Research, University of Tsukuba
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 06 | Day |
Last modified on
| 2016 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024643
