UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on usefulness of Walking Assist Device for gait disturbance
Title of the study (Brief title)	Usefulness of Walking Assist Device
Region	Japan

Condition
Condition	Gait disturbance
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate whether use of Walking Assisit Device in rehabilitation results in improvement for patients with chronic gait disturbance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Two times a week rehabilitation are performed for 5 weeks. We study 10 min walk test at the end of 5 weeks.
Key secondary outcomes	length of stride Cadence

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	We investigate whether chronic gait disturbance improve by rehabilitation using Walking Assist Device. Rehabilitation is performed 2 times a week for 5 weeks.
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	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	patients performed rehabilitation at National Defense Medical College Hospital Functional Ambulation Category >= 2 width between great trochanter: 290 - 372mm length from hip to above patell 5cm: 306 - 363mm obtained informed consent for research
Key exclusion criteria	severe complication severe joint contracture unhealed operation wound epiepsy dementia unable to obey instructions from therapists
Target sample size	40

Research contact person
Name of lead principal investigator	Tatsuo Kobayashi
Organization	National Defense Medical College
Division name	Rehabilitation
Address	3-2, Namiki, Tokorozawa
TEL	04-2995-1511
Email	tkobayas@ndmc.ac.jp

Public contact
Name of contact person	Tatsuo Kobayashi
Organization	National Defense Medical College
Division name	Rehabilitation
Address	3-2, Namiki, Tokorozawa
TEL	04-2995-1511
Homepage URL
Email	tkobayas@ndmc.ac.jp

Sponsor
Institute	National Defense Medical College
Institute
Department

Funding Source
Organization	National Defense Medical College
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	防衛医科大学校（埼玉）

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 20 Day
Anticipated trial start date	2014 Year 07 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 10 Month 30 Day
Last modified on	2018 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022523