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

NCT06756256 | Completed DMC

• 1 other identifier: WonkwangUoS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 1.MediACE Scanner-MS320F will be used to evaluate foot alignment and will create customized insole.
2. 2.Exbody 770 will be used to measure body alignment.
3. 3.Timed up \& go test will be used to evaluate dynamic balance.

Conditions

Stroke

Keywords

Stroke; Insole; Foot arch; Body alignment; Balance

Outcome Measures

Primary Outcomes (3)

• Foot alignment

  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

  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

  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.

Study Arms (2)

3D Insole

EXPERIMENTAL

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

Control_without 3D Insole

NO INTERVENTION

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.

Interventions

Customized insole DEVICE

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.

Also known as: Insole made by MediAce Scanner-MS320F

3D Insole

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sharjah: lead

Study Sites (1)

Wonkwang Health Science University

Iksan, Jeolla, South Korea

Location

Related Publications (5)

• Wang J, Qiao L, Yu L, Wang Y, Taiar R, Zhang Y, Fu W. Effect of Customized Insoles on Gait in Post-Stroke Hemiparetic Individuals: A Randomized Controlled Trial. Biology (Basel). 2021 Nov 15;10(11):1187. doi: 10.3390/biology10111187.

  PMID: 34827179 BACKGROUND

• Hozein M, Mortada H, Hamed M, Abdelhaleem N, Elshennawy S. Effect of insole on postural control and gait of stroke patients: a systematic review and meta-analysis. Int J Rehabil Res. 2024 Sep 1;47(3):137-146. doi: 10.1097/MRR.0000000000000632. Epub 2024 Jun 17.

  PMID: 38881488 BACKGROUND

• Liu YT, Tsai HT, Hsu CY, Lin YN. Effects of orthopedic insoles on postural balance in patients with chronic stroke: A randomized crossover study. Gait Posture. 2021 Jun;87:75-80. doi: 10.1016/j.gaitpost.2021.04.014. Epub 2021 Apr 20.

  PMID: 33894465 BACKGROUND

• Ma CC, Rao N, Muthukrishnan S, Aruin AS. A textured insole improves gait symmetry in individuals with stroke. Disabil Rehabil. 2018 Nov;40(23):2798-2802. doi: 10.1080/09638288.2017.1362477. Epub 2017 Aug 7.

  PMID: 28783984 BACKGROUND

• Fu JC, Chen YJ, Li CF, Hsiao YH, Chen CH. The effect of three dimensional printing hinged ankle foot orthosis for equinovarus control in stroke patients. Clin Biomech (Bristol). 2022 Apr;94:105622. doi: 10.1016/j.clinbiomech.2022.105622. Epub 2022 Mar 11.

  PMID: 35325715 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Meeyoung Kim

  University of Sharjah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants and outcome assessors will be blinded to the treatment methods and group allocation. Assessor blinding will be obtained through an independent research assist: not knowing the study design and not specifically involved in any other aspect of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A prospective, double-blinded, parallel, randomized clinical trial. 20 participants will be divided into 2 groups, intervention and control group. 10 will be in the intervention group that will wear the customized insole for 6 weeks whereas the 10 others will not during the same period of time.

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 1, 2025
• Study Start: March 20, 2025
• Primary Completion: April 30, 2025
• Study Completion: July 10, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After 6 months of completing a study and available for one year
• Access Criteria: Not identified yet

Locations

KR (1)