Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516900
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-29
Brief Title:
Reducing Foot Pain and Peak Plantar Pressure in Patients With Foot Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Comparison of the Effectiveness of OrthoFeet HandsFree Therapeutic Shoes in Reducing Foot Pain and Peak Plantar Pressure
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The research project aims to evaluate the effectiveness of OrthoFeet Hands-Free therapeutic shoes and prefabricated inserts in patients with foot pain
Detailed Description:
Patients with foot pain frequently have gait dysfunctions resulting in higher mechanical stress and peak plantar pressure in some areas of the foot Older people with foot pain have impaired balance and reduced walking speed compared to those without foot pain Higher peak plantar pressure further increases the risk of falls in older populations By wearing custom-fit devices such as prefabricated depth shoes footwear modifications and orthoses patients can redistribute pressure by lowering the peak plantar pressure in specific areas Similarly these custom-fit devices and shoes may mitigate the level of pain in patients after wearing the shoes for a certain period Understanding how different orthotics shoes and inserts redistribute plantar pressure and lower foot pain is essential to prescribing the proper footwear to foot pain patients The proposed study will investigate the effectiveness of OrthoFeet Hands-Free therapeutic shoes and prefabricated inserts in patients with foot pain compared to their own shoes This will be achieved by completing four aims The first aim will determine the patient shoe wearing compliance comfort acceptance and feasibility of OrthoFeet Hands-Free therapeutic shoes in patients with foot pain For the second aim the investigators will determine the effectiveness of reducing foot pain after a 6-weeks intervention of wearing OrthoFeet Hands-Free therapeutic shoes The third aim will determine the progressive improvements in physical activity quality of life and reduction in peak plantar pressure following a 6-weeks intervention period For the fourth aim the investigators will compare the effectiveness of reducing plantar pressure between OrthoFeet Hands-Free therapeutic shoes and patients own shoes The investigators hypothesize that the degree of foot pain mitigates with reduced peak plantar pressure in patients with foot pain after a 6-weeks intervention of wearing OrthoFeet Hands-Free therapeutic shoes greater than occurs when patients continue to wear their own customary shoes The outcomes from the study will provide a better scenario of how the OrthoFeet shoes and inserts impact the plantar pressure distribution during walking in patients with foot pain This will further help in future research studies to modify existing designs and guide the development of novel therapeutic treatments for foot pain patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None