Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT06756256
Status:
RECRUITING
Last Update Posted:
2025-06-27
First Post:
2024-12-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Foot Insole on Body Alignment, and in Stroke Patients
Sponsor:
University of Sharjah
Organization:
Study Overview
Official Title:
The Effect of Wearing Customized Insole on Foot Alignment, Body Alignment, and Balance Ability in Stroke Patients
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: