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

February 25, 2026 updated by: Meeyoung Kim, University of Sharjah

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Jeolla
      • Iksan, Jeolla, South Korea
        • Wonkwang Health Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Chronic (more than 1 year ago) stroke patient over 50 years old
  • MMSE (mini-mental state examination) score of 24 or higher out of 30, capable of understanding the experimenter's instructions
  • No history of orthopedic surgery
  • Voluntarily agreed to participate

Exclusion Criteria:

  • Neurological problems other than stroke affecting balance ability
  • Movement restrictions or involuntary limb movements due to ankle pain
  • Severe visual impairment, field defects, cognitive impairment making it impossible to use evaluation equipment
  • Taking medication affecting posture and balance ability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D Insole

Intervention group who will wear the customized insole for 6 weeks during daily activities. Insole production will be through the following process.

The participants' feet will be visually inspected for abnormalities, and the MediAce Scanner-MS320F will scan the feet in a seated position with the knees and ankles fixed at 90°. MediAce Scanner-MS320F's software will automatically calculate and correct the anatomical position of bones and joints. The corrected models will produce the printed insoles.

Apart from wearing insole, they will receive the physiotherapy treatment as their continuation of rehabilitation program.
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.
Other Names:
  • Insole made by MediAce Scanner-MS320F
No Intervention: Control_without 3D Insole
Participants in the control group will not wear the customized insoles for 6 weeks. They will receive the physiotherapy treatment as their continuation of rehabilitation program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot alignment
Time Frame: Outcome measure will be done twice before and after 6 weeks' intervention period.

Foot alignment will be measured with 3 parameters including medial longitudinal arch angle, transverse arch angle, and arch height. Measurement will be performed by MediACE Scanner-MS320F (Real Dimension Co., South Korea).

Outcome measure will be done twice before and after 6 weeks' intervention period as below. The MediACE Scanner-MS320F analyzes anatomical information of the leg by applying a marker recognition algorithm to 15 bones and joints of the foot, measuring angles and heights of the medial longitudinal arch, transverse arch, medial malleolus, and navicular bone tuberosity.
Outcome measure will be done twice before and after 6 weeks' intervention period.
Body alignment
Time Frame: Outcome measure will be done twice before and after 6 weeks' intervention period.

Body alignment will be measured with 3 parameters including shoulder tilt angle, pelvic tilt angle, and knee tilt angle. Measurement will be conducted by Exbody 770 (Exbody Co., South Korea) before and after 6 weeks' intervention period as following procedure.

The Exbody 770 identifies joints automatically with an infrared camera, examines musculoskeletal misalignment and imbalance, and visually confirms body alignment by displaying the condition of the cervical, lumbar, knee, and ankle joints in 3D from the front and side.
Outcome measure will be done twice before and after 6 weeks' intervention period.
Timed Up & Go
Time Frame: Outcome measure will be done twice before and after 6 weeks' intervention period.

The Timed Up & Go test will be used to measure balance ability before and after 6 weeks' intervention period. Procedure description is as below.

Participants, wearing comfortable shoes, rise from a chair with armrests, walk 3 meters, turn around, and sit back down, timed without assistance. The average of three trials will be used as their balance ability.
Outcome measure will be done twice before and after 6 weeks' intervention period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sharjah

Investigators

  • Principal Investigator: Meeyoung Kim, University of Sharjah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2025

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

July 10, 2025

Study Registration Dates

First Submitted

December 25, 2024

First Submitted That Met QC Criteria

December 25, 2024

First Posted (Actual)

January 1, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WonkwangUoS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

There is a plan to make IPD and related data dictionaries available.

IPD Sharing Time Frame

After 6 months of completing a study and available for one year

IPD Sharing Access Criteria

Not identified yet

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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