UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of early making a knee ankle foot orthosis during acute phase in severe hemiplegic patients for functional independence measure of walking and stair climbing.
Title of the study (Brief title)	The effect of early making a knee ankle foot orthosis during acute phase in severe hemiplegic patients for functional independence measure of walking and stair climbing.
Region	Japan

Condition
Condition	severe hemiplegic patients
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Hemiplegic cases in which long limb orthosis was created at an acute hospital and admitted to the rehabilitation period rehabilitation ward and cases of hemiplegia who were hospitalized during recovery phase rehabilitation ward (hereinafter referred to as rehabilitation rehabilitation ward) without preparation, walking and stairs Retrospectively investigated the trend of the FIM score of the Functional Independence Measure (FIM) of lift and retrospectively and found that early long limb orthosis preparation in the case of severe hemiplegia after brain injury is long term FIM Investigate the impact on change.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Of the severe hemiplegic cases who were admitted to the rehabilitation period ward in our hospital for 2 years from 2010, 8 patients who produced KAFO at the acute phase hospital were treated as KAFO group and the recovery period rehabilitation ward Twenty patients admitted to the hospital were extracted as a non-prepared group, and two groups of FIM gait and temporal changes of FIM stairs were investigated.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	18 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	The patients who prescribed KAFO. The patients who need KAFO during gait exercise.
Key exclusion criteria	The patients who did not need KAFO.
Target sample size	20

Research contact person
Name of lead principal investigator	Yuji Takashima
Organization	Nagamachi Hospital
Division name	Department of Rehabilitation
Address	3-7-26 nagamachi taihaku sendai
TEL	022-746-5161
Email	ngmtrpt@yahoo.co.jp

Public contact
Name of contact person	Yuji Takashima
Organization	Nagamachi Hospital
Division name	Department of Rehabilitation
Address	3-7-26 nagamachi taihaku sendai
TEL	022-746-5161
Homepage URL
Email	ngmtrpt@yahoo.co.jp

Sponsor
Institute	Nagamachi Hospital
Institute
Department

Funding Source
Organization	Nagamachi Hospital
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	2018 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 11 Day
Anticipated trial start date	2015 Year 04 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	Observational study The patient with severe hemiplegia who was hospitalized in the rehabilitation period ward for 2 years from 2010 was diagnosed as having one of the hemiplegic who prepared the long limb orthosis from the acute hospital and the hemiplegic who was transferred without preparing it, Over time were compared.

Management information
Registered date	2017 Year 04 Month 11 Day
Last modified on	2017 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030587