UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of ankle foot orthosis within peripheral nerve palsy and cerebral palsy patients
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yukihide Nishimura
Organization	Wakayama Medical University
Division name	Department of Rehabilitation Medicine
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	Yukihide Nishimura
Organization	Wakayama Medical University
Division name	Department of Rehabilitation Medicine
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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