UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035275 |
|---|---|
| Receipt number | R000040189 |
| Scientific Title | Adaptation of Ankle foot orthosis to gait disturbance in post-stroke |
| Date of disclosure of the study information | 2018/12/26 |
| Last modified on | 2020/02/01 00:26:36 |
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Basic information
Public title
Adaptation of Ankle foot orthosis to gait disturbance in post-stroke
Acronym
Adaptation of Ankle foot orthosis to gait disturbance in post-stroke
Scientific Title
Adaptation of Ankle foot orthosis to gait disturbance in post-stroke
Scientific Title:Acronym
Adaptation of Ankle foot orthosis to gait disturbance in post-stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the adaptation of Ankle foot orthosis to gait disturbance in post-stroke cases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Spatiotemporal parameters during gait in different conditions of Ankle foot orthosis(gait speed, step length, duration of single leg stance and double support)
Key secondary outcomes
Muscle activities of lower limbs during gait in different conditions of Ankle foot orthosis
Gait parameters without Ankle foot orthosis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Ankle foot orthosis(ankle joint plantar-dorsiflexion stop)
Interventions/Control_2
Ankle foot orthosis(ankle joint dorsiflexion free and plantar flexion stop)
Interventions/Control_3
Ankle foot orthosis(ankle joint dorsiflexion free and plantarflexion oil damper)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. can 10 meters walk without assist
2.MMSE 24 scores or more
Key exclusion criteria
1. Other neurological disorders and orthopedic disease
2.lower limbs pain
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naruhito Hasui |
Organization
Kio University
Division name
Department of Neurorehabilitation, Graduate School of Health Science
Zip code
Address
4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
TEL
+81-745-54-1601
reha.pt1016@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naruhito Hasui |
Organization
Kio University
Division name
Department of Neurorehabilitation, Graduate School of Health Science
Zip code
Address
4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
TEL
+81-745-54-1601
Homepage URL
reha.pt1016@gmail.com
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
No
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
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
宝塚リハビリテーション病院(兵庫県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 26 | 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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 05 | 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 | 12 | Month | 17 | Day |
Last modified on
| 2020 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040189
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
