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

Not Applicable

Recruiting

• Conditions: Stroke

• Registration Number: NCT06756256
• Lead Sponsor: University of Sharjah

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. 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.

Study Timeline

• Study First Submitted: 2024-12-25
• Study First Submitted QC: 2024-12-25
• Study First Posted: 2025-01-01
• Status Verified: 2025-02
• Study Start: 2025-03-20
• Primary Completion: 2025-04-30
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-23
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Foot alignment	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.
Body alignment	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.
Timed Up & Go	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.

Trial Locations

Locations (1)

Wonkwang Health Science University; 🇰🇷 Iksan, Jeolla, Korea, Republic of