臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 19, 2022
Last modified on	Oct. 15, 2024
Trial ID	jRCTs042210131

Scientific Title	Innovative development of gait assistant device and rehabilitation protocol to intend improvement of gait speed for adult scoliosis
Public Title	Innovative development of gait assistant device for adult scoliosis

Completion date	Sept. 09, 2024
Result actual enrolment	3
Baseline Characteristics	Patients with adult spinal deformity
Participant flow	None
Adverse events	None
Outcome measures	None
Brief summary	None
Date of posting of results summaries	Sept. 09, 2024

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/jRCTs042210131

Contact for Scientific Queries	Name	Iwai Chizuo
	Affiliation	Gifu University Hospital
	Address	1-1, Yanagido, Gifu city, Gifu
	Telephone	+81-58-230-6333
	E-mail	chizukun@gifu-u.ac.jp
Contact for Public Queries	Name	Iwai Chizuo
	Affiliation	Gifu University Graduate school of medicine
	Address	1-1, Yanagido, Gifu city, Gifu
	Telephone	+81-58-230-6333
	E-mail	chizukun@gifu-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Jan. 19, 2022
Actual date of first enrollment		Oct. 17, 2022
Target sample size		28
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients met all criteria as below (1) have an adult spinal deformity plannning operation in gifu university hospital (2) adult (3) good communication (4) written consent has been obtained
	Exclusion Criteria	(1) superimposed adolescent idiopathic scoliosis (2) neuromuscular scoliosis (3) syndromic scoliosis (4) difficulty in stable walking due to severe spinal imbalance (5) during pregnancy or lactation, potential or willingness (6) postoperative progression of spinal deformity in proximal or distal junction (7) using gait assistant device such as a cane to compensate for decline of ADL (8) patients considered ineligible for enrolling the study by a principal investigator or sub-investigator
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Adult Spinal Deformity (ASD)
Intervention(s)		Electromyogram synchronized gait analysis with or without ACSIVE at preoperative and postoperative 1 month and 1 year
Health Condition(s) Keyword		adult spinal deformity, gait analysis, EMG analysis,
Intervention(s) Keyword		adult spinal deformity, gait analysis, EMG analysis,
Health Condition(s) Code		joint deformities
Intervention(s) Code		joint deformities
Primary Outcome(s)		A comparison gait speed(m/s) between with and without ACSIVE due to gait analysis preoperatively.
Secondary Outcome(s)		(1) A comparison gait speed between with and without ACSIVE due to gait analysis postoperative 1 month and 1 year. (2) some gait parameters by VICON walking rate per 1 gait cycle step length of stride swing phase double supporting phase Max and Min. ROM of pelvis and lower extremity (3) some parameters of EMG 50 percentage muscle activity percentage maximum voluntary contraction integrated Electromyogram of some muscles (back cervical muscle, back muscle, lumbar muscle, abdominal muscle, rectus femoris muscle, biceps femoris muscle, tibialis anterior muscle, gastrocnemius muscle)

Source of Monetary Support	Grant in Aid for Scientific Research, Grant in Aid for Scientific Research(C)
Secondary Sponsor	Not applicable

Name of Certified Review Board	Nagoya City University Certified Review Board
Address	1,Kawasumi,Mizuhocho,Mizuhoku,Nagoya,Aichi, Aichi
Telephone	+81-52-853-8346
E-Mail	rinshou-kenkyu@med.nagoya-cu.ac.jp
Approval Status	Approval
Date of approval	Nov. 24, 2021

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Oct. 15, 2024	(this page)	Changes
3	Aug. 01, 2024	Detail	Changes
2	Oct. 17, 2022	Detail	Changes
1	Jan. 19, 2022	Detail

List of change history