UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of upper extremity function in patients with neurodegenerative diseases using electric pegboard
Title of the study (Brief title)	Evaluation of upper extremity function in patients
Region	Japan

Condition
Condition	spinocerebellar degeneration
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop the subjective and quantitative method in spinocerebellar degeneration
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	speed, acceleration, trajectory
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	upper extremity test
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with spinocerebellar disease
Key exclusion criteria	Patients with spinocerebellar disease, along with intracranial disease and/or spinal disease
Target sample size	20

Research contact person
Name of lead principal investigator	Yoshio IKEDA
Organization	Gunma University Graduate School of Medicine
Division name	Department of Neurology
Address	3-39-22, Showa, Maebashi, Gunma, Japan
TEL	027-220-8060
Email	ikeday006@gunma-u.ac.jp

Public contact
Name of contact person	Yukio FUJITA
Organization	Gunma University Graduate School of Medicine
Division name	Department of Neurology
Address	3-39-22, Showa, Maebashi, Gunma, Japan
TEL	027-220-8060
Homepage URL
Email	yfujita@gunma-u.ac.jp

Sponsor
Institute	Department of Neurology, Gunma University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Rehabilitation Sciences, Gunma University Graduate School of Health Sciences
Organization
Division
Category of Funding Organization	Japanese Governmental office
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 02 Month 14 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 02 Month 14 Day
Anticipated trial start date	2018 Year 10 Month 31 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	2018 Year 02 Month 14 Day
Last modified on	2018 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035731