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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021984
Receipt No. 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

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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
Email 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
Email yuki-n@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025275

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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