臨床研究等提出・公開システム

Japanese

Date of registration	April. 24, 2024
Last modified on	Jan. 15, 2025
Trial ID	jRCTs052240014

Scientific Title	The Digital insoles Effectiveness for lower limb disordERs (DEER Study)
Public Title	DEER Study (DEER Study)

Contact for Scientific Queries	Name	Inagaki Yusuke
	Affiliation	Nara Medical University Hospital
	Address	840 Shijo-cho, Kashihara, Nara, JAPAN
	Telephone	+81-744-22-3051
	E-mail	yinagaki@naramed-u.ac.jp
Contact for Public Queries	Name	Kawai Akihito
	Affiliation	Nara Medical University Hospital
	Address	840 Shijo-cho, Kashihara, Nara, JAPAN
	Telephone	+81-744-22-3051
	E-mail	akihitokawai@naramed-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 24, 2024
Actual date of first enrollment		July. 30, 2024
Target sample size		40
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	1) Patients diagnosed with lower limb disorders at Nara Medical University Hospital 2) Patients who have pain and require conservative treatment 3) Patients aged 18 to 85 4) Patients who can walk independently 5) Patients who have given written consent to participate in this clinical research
	Exclusion Criteria	1) Patients with dermatitis requiring treatment at the site of application of the product 2) Patients who have difficulty understanding explanations or instructions 3) Patients who are deemed inappropriate as research subjects by the principal investigator or sub investigator
	Age Minimum	18age old over
	Age Maximum	85age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		lower limb disorders (hallux valgus, flat feet, knee osteoarthritis)
Intervention(s)		Fitting of digital insoles created using the footscan system
Health Condition(s) Keyword		Lower limb disorders, hallux valgus, flat feet, knee osteoarthritis
Intervention(s) Keyword		Insole
Health Condition(s) Code		D007592
Intervention(s) Code
Primary Outcome(s)		Change in COP trajectory before and immediately after intervention
Secondary Outcome(s)		1) Change in COP before intervention and at 12 weeks after intervention 2) Change in VAS before, immediately after, and 12 weeks after intervention 3) Change in TUG before, immediately after, and 12 weeks after intervention 4)Change in Xp before and at 12 weeks after intervention

Primary Sponsor

Source of Monetary Support / Secondary Sponsor	MediaMart Co.,Ltd.
Secondary Sponsor	Not applicable

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Nara Medical University Certified Review Board
Address	840 Shijo-cho Kasihara, Nara
Telephone	+81-744-29-8835
E-Mail	ethics_nara@naramed-u.ac.jp
Approval Status	Approval
Date of approval	April. 18, 2024

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Jan. 15, 2025	(this page)	Changes
1	April. 24, 2024	Detail

List of change history