UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021984 |
|---|---|
| Receipt number | R000025275 |
| Scientific Title | The effect of ankle foot orthosis within peripheral nerve palsy and cerebral palsy patients |
| Date of disclosure of the study information | 2016/04/19 |
| Last modified on | 2016/04/19 18:21:07 |
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Basic information
Public title
The effect of ankle foot orthosis within
peripheral nerve palsy and cerebral palsy patients
Acronym
The effect of ankle foot orthosis
Scientific Title
The effect of ankle foot orthosis within
peripheral nerve palsy and cerebral palsy patients
Scientific Title:Acronym
The effect of ankle foot orthosis
Region
| Japan |
Condition
Condition
peripheral nerve palsy, hemiparesis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
he purpose of this study was to compare the effects of AFO on functional ambulation in patients with hemiplegia and unilateral lower-extremity palsy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional ambulation was assessed with AFO and without AFO by 10-meter maximum walking speed (10MMWS) and the distance walked in a 6-minute walking test (6MWT). Functional balance was assessed using the Berg balance scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
with AFO
Interventions/Control_2
without AFO
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
no history of injury or pathology in the uninvolved lower limb; 2) ability to walk independently or with supervision for 6 minutes, both with and without AFO; and 3) wearing AFO for more than 50% of the walking time
Key exclusion criteria
The patients whom it does not apply to as above
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihide Nishimura |
Organization
Wakayama Medical University
Division name
Department of Rehabilitation Medicine
Zip code
Address
811-1 Kimiidera, Wakayama city,Wakayama 641-8509, Japan
TEL
073-441-0664
yuki-n@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihide Nishimura |
Organization
Wakayama Medical University
Division name
Department of Rehabilitation Medicine
Zip code
Address
811-1 Kimiidera, Wakayama city,Wakayama 641-8509, Japan
TEL
073-441-0664
Homepage URL
yuki-n@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
none
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 19 | 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
| 2014 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | 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 | 04 | Month | 19 | Day |
Last modified on
| 2016 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025275
