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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-20

Study Completion Date

2025-07-10

Brief Summary

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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.

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Detailed Description

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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

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Customized insole

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Insole made by MediAce Scanner-MS320F

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No