UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031194 |
|---|---|
| Receipt number | R000035611 |
| Scientific Title | The effects of gait training using an ankle-foot orthosis with a modular exoskeletal robot actuated by pneumatic artificial muscles |
| Date of disclosure of the study information | 2018/02/07 |
| Last modified on | 2019/08/10 20:00:56 |
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Basic information
Public title
The effects of gait training using an ankle-foot orthosis with a modular exoskeletal robot actuated by pneumatic artificial muscles
Acronym
The effects of gait training using a powered ankle-foot orthosis
Scientific Title
The effects of gait training using an ankle-foot orthosis with a modular exoskeletal robot actuated by pneumatic artificial muscles
Scientific Title:Acronym
The effects of gait training using a powered ankle-foot orthosis
Region
| Japan |
Condition
Condition
Stroke patients with hemiparesis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The treatment effects of hemiparetic gait training using an ankle-foot orthosis with a modular exoskeletal robot
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of ankle movements during hemiparetic gait just after and after 1 month of treatments
Key secondary outcomes
The kinematic changes during hemiparetic gait
The changes of EMG patterns during hemiparetic gait
Muscular powers during stepping
Gait speeds
Gait Assessment and Intervention Tool scores
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Ankle robot gait trainings (15 sessions, 30 minutes/session)
Interventions/Control_2
Conventional gait training (15 sessions, 30 minutes/session)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Passive ankle range of motion of 40 degrees or more
The ankle proprioceptive ability of about 10 degrees
Independent indoor walking with an ankle-foot orthosis
Key exclusion criteria
Sensory loss of paretic foot
Neuromuscular or joint diseases affecting gait
Severe aphasia or cognitive disorders
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kimitaka |
| Middle name | |
| Last name | Hase |
Organization
Kansai Medical University
Division name
Physical Medicine of Rehabilitation
Zip code
573-1191
Address
3-1 Shinmachi 2 Chome, Hirakata City, Osaka
TEL
+81-72-804-0101
hasekim@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Kimitaka |
| Middle name | |
| Last name | Hase |
Organization
Kansai Medical University
Division name
Physical Medicine of Rehabilitation
Zip code
573-1191
Address
3-1 Shinmachi 2 Chome, Hirakata City, Osaka
TEL
+81-72-804-0101
Homepage URL
hasekim@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committees of the Kansai Medical University hospital
Address
2-3-1, Shinmachi, Hirakata, Osaka
Tel
+81-72-804-0101
kmu@esct.bvits.com
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 | 02 | Month | 07 | 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
19
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
| 2017 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 19 | 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
| 2018 | Year | 02 | Month | 07 | Day |
Last modified on
| 2019 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035611
