NCT06756256

Effect of Foot Insole on Body Alignment, and in Stroke Patients

The Effect of Wearing Customized Insole on Foot Alignment, Body Alignment, and Balance Ability in Stroke Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Sharjah · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Goal: This study will be conducted to find out the effects of customized insole on foot alignment, body alignment, and balance ability of stroke patients. Recruitment: Total 20 participants will be recruited and will be divided into 2 groups: Intervention and control group with or without wearing foot insole for 6 weeks. Evaluation tool: 1. MediACE Scanner-MS320F will be used to evaluate foot alignment and will create customized insole. 2. Exbody 770 will be used to measure body alignment. 3. Timed up \& go test will be used to evaluate dynamic balance. Intervention: The intervention group will wear a customized insole during daily life for 6 weeks whereas the control group will not. Evaluation will be conducted 2 times before and after 6 weeks.

Detailed description

This study will recruit 20 stroke patients and will randomly assign them to the intervention group (n=10) and control group (n=10). After given the full description of the study, participants who will voluntarily agreed to participate will be included. This study involves producing customized insoles for participants to wear during daily activities for six weeks. The customized insoles will be produced using the MediAce Scanner-MS320F, which scans the participants' feet in a seated position. The participants in the intervention group will wear the produced insoles during daily activities. Their rehabilitation program will be continued apart from the insole wearing. The participants in the control group will wear their normal insoles during daily activities. Also, their rehabilitation program will be continues as same as the intervention group. Outcome measure will be conducted twice, pre- and post-intervention. It includes foot alignments and arch height using the MediACE Scanner-MS320F, body alignments using the Exbody 770, and balance ability using the Timed Up \& Go test.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Customized insole	Participants will wear the produced customized insoles during daily activities and interventions for six weeks under the guidance of physical therapists working at Miso Hospital in Iksan City. As their continuation of their rehabilitation program, they will receive a conservative physiotherapy treatment five times a week for six weeks.

Timeline

• Start date: 2025-03-20
• Primary completion: 2025-04-30
• Completion: 2025-07-10
• First posted: 2025-01-01
• Last updated: 2026-02-27

Locations

1 site across 1 country: South Korea