Clinical trial NCT06756256: Effect of Foot Insole on Body Alignment, and in Stroke Patients
Official title: The Effect of Wearing Customized Insole on Foot Alignment, Body Alignment, and Balance Ability in Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Insole
Foot arch
Body alignment
Balance
Lead sponsor: University of Sharjah
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Foot alignment
timeFrame: Outcome measure will be done twice before and after 6 weeks' intervention period.
measure: Body alignment
timeFrame: Outcome measure will be done twice before and after 6 weeks' intervention period.
measure: Timed Up & Go
timeFrame: Outcome measure will be done twice before and after 6 weeks' intervention period.
Secondary outcomes:
Other outcomes:
Locations:
city: Iksan
country: Korea, Republic of
facility: Wonkwang Health Science University
state: Jeolla
Study officials:
affiliation: University of Sharjah
name: Meeyoung Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.