DEER Study

JRCT ID: jRCTs052240014

Registered date:24/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: lower limb disorders (hallux valgus, flat feet, knee osteoarthritis)
• Date of first enrollment: 24/04/2024
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Fitting of digital insoles created using the footscan system

Outcome(s)

• Primary Outcome: Change in COP trajectory before and immediately after intervention

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Inagaki Yusuke
• Source(s) of Monetary Support: MediaMart Co.,Ltd.