臨床研究等提出・公開システム

Japanese

Date of registration	April. 22, 2022
Last modified on	Feb. 07, 2023
Trial ID	jRCTs052220012

Scientific Title	A study of the short-term gait improvement effect using a biological signal reaction type motor function improvement device for gait instability in pati ents with Parkinson's disease. a randomized controlled trial
Public Title	A study of the short-term gait improvement effect using a biological signal reaction type motor function improvement device in patients with Parkinson's disease.

Completion date	Dec. 20, 2022
Result actual enrolment	0
Baseline Characteristics	No cases registered, none noted.
Participant flow	Consent was obtained from the first subject on November 9, 2022, for a total of three subjects, who were awaiting hospitalization for rehabilitation. Due to the COVID-19 outbreak, it was difficult to secure hospital beds for rehabilitation purposes, so the study was discontinued.
Adverse events	No cases registered, none noted.
Outcome measures	No cases registered, none noted.
Brief summary	No cases registered, none noted.
Date of posting of results summaries	Feb. 06, 2023
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	None
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs052220012

Contact for Scientific Queries	Name	Kohara Nobuo
	Affiliation	Kobe City Medical Center General Hospital
	Address	2-1-1 Minatojima minamimachi,Chuo-ku,Kobe Cit y,Hyogo
	Telephone	+81-783024321
	E-mail	kohara2010@kcho.jp
Contact for Public Queries	Name	Shirono Utako
	Affiliation	Kobe City Medical Center General Hospital
	Address	2-2 Minatojima minamimachi,Chuo-ku,Kobe City,Hyogo
	Telephone	+81-78-302-4321
	E-mail	ushirono@kcho.jp

Recruitment status	Complete

Anticipated date of first enrollment		April. 01, 2022
Actual date of first enrollment
Target sample size		30
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1)Those who have been diagnosed with clinically established or clinically probable cases according to the clinical diagnostic criteria for Parkinson's disease by the Movement Disorder Society (MDS). 2) Hoehn-Yahr Scale stage III 3) Those who have not changed the type and dos e of Parkinson's drug before 4 weeks of the date o f consent acquisition and have no plans to change it while participating in clinical research. 4) Those who do not have a clear wearing-off phe nomenon. 5) Those who are judged by the doctor that their g eneral condition is stable and that standing / walki ng training can be carried out. 6) Those who can stand up and sit and walk 10 m or more without assistance (regardless of the use of assistive devices). 7) Those who are 20 years old or older at the time of consent 8) Those who have obtained the document conse nt of the subject. 9) Those who meet the following conditions descri bed in the HAL package insert a) Weight 40-100kg b) Those who can wear HAL with a height of about 150 to 190 cm or a body size such as thigh length, lower leg length, and waist width. 10) Those who can about21-day rehabilitation hos pitalization for PD.
	Exclusion Criteria	1)Those who the doctor judges to be inappropriat e, such as improper standing and walking training 2)Those who have difficulty wearing HAL due to p hysical deformation, etc. 3) Those who have difficulty in attaching electrode s due to skin diseases, etc. 4) Those who are pregnant 5) Those who have a cognitive function test (MMS E) of 23 points or less. 6)In addition, those who are judged to be inappro priate for conducting this research by the principal investigator or the other investigator.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Parkinson's disease
Intervention(s)		The normal rehabilitation group and the HAL grou p are assigned 1: 1 and the normal rehabilitation g roup is subjected to normal walking training, and t he HAL group is subjected to walking training by H AL.
Health Condition(s) Keyword		Parkinson's disease
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		2 minutes walking distance
Secondary Outcome(s)		10m walking time Walking speed Walking rate Stride SPPB ADL FIM UPRDS Part 3 ESAS GSES Posture tilt of body axis Timed Up and Go Test TUG

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Kobe city medical center general hospital certified review bo ard
Address	2-1-1, Minatojima-minamimachi, Chuo-ku, Kobe-city, Hyogo, Hyogo
Telephone	+81-78-302-5176
E-Mail	c_crb@kcho.jp
Approval Status	Approval
Date of approval	Mar. 30, 2022

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Feb. 07, 2023	(this page)	Changes
2	Jan. 27, 2023	Detail	Changes
1	April. 22, 2022	Detail

List of change history