Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426576
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-17
Brief Title:
Load Limits After Orthopaedic Surgery Biofeedback vs Conventional Method AppPWB
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Application of Load Limits After Orthopaedic Surgery With Biofeedback-based Instructions Compared to a Conventional Method
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
The aim of this single-centre prospective randomized-controlled clinical trial is to assess whether patients adhere to prescribed weight bearing limits after surgical orthopaedic or traumatological interventions more accurately after instruction using a biofeedback method than using the standard method
Detailed Description:
Partial weight bearing commonly prescribed post-surgery in orthopaedics and traumatology aims to stimulate healing while preventing overloading Partial weight bearing refers to that the patient is only allowed to put 10 to 50 of their body weight on the affected limb
The most commonly used method for instructing partial weight bearing with the patient is using a personal scale This means that the patient can only exercise in a static position and the perceived load must be transferred to dynamic activities of daily living without further feedback Previous reports indicate that patients often struggle to adhere to prescribed partial weight-bearing limits frequently exceeding the specified load by 100 or more However when additional feedback was incorporated into training approximately 90 of subjects successfully adhered to the partial load
Portable or wearable measuring systems such as pressure-sensitive insoles offer feedback during dynamic tasks facilitating a smoother transition to daily activities Unlike the standard one-time instruction using a scale these systems provide repeated feedback at each step promoting a higher frequency of exercises This aids patients in developing a better sense of the correct load
This single-centre prospective randomized-controlled clinical trial aims to investigate the effectiveness of pressure insoles connected to a smartphone via Bluetooth and operated using an app in improving partial weight bearing adherence The insoles provide direct feedback through acoustic and visual signals if the affected leg is overloaded possibly leading to a lower proportion of steps over the load limit compared to those without feedback Participants are randomized into either the intervention group dynamic condition - plantar pressure insoles or the control group static condition - standard one-off instruction using a scale
The primary objective is to determine whether the proportion of steps exceeding the weight bearing limit is lower in the intervention group compared to the control group 2 weeks after surgery Secondary objectives include assessing subjective ratings of the permitted load perceived pain and mobility Additionally the trial hypothesizes that patients using the insoles can estimate applied load more accurately The intervention group will also provide feedback on the usability of the app and insoles
The results of this trial will contribute to enhancing postoperative treatment of patients undergoing orthopaedic surgery thereby improving treatment outcomes and optimizing therapy regimens
The most commonly used method for instructing partial weight bearing with the patient is using a personal scale This means that the patient can only exercise in a static position and the perceived load must be transferred to dynamic activities of daily living without further feedback Previous reports indicate that patients often struggle to adhere to prescribed partial weight-bearing limits frequently exceeding the specified load by 100 or more However when additional feedback was incorporated into training approximately 90 of subjects successfully adhered to the partial load
Portable or wearable measuring systems such as pressure-sensitive insoles offer feedback during dynamic tasks facilitating a smoother transition to daily activities Unlike the standard one-time instruction using a scale these systems provide repeated feedback at each step promoting a higher frequency of exercises This aids patients in developing a better sense of the correct load
This single-centre prospective randomized-controlled clinical trial aims to investigate the effectiveness of pressure insoles connected to a smartphone via Bluetooth and operated using an app in improving partial weight bearing adherence The insoles provide direct feedback through acoustic and visual signals if the affected leg is overloaded possibly leading to a lower proportion of steps over the load limit compared to those without feedback Participants are randomized into either the intervention group dynamic condition - plantar pressure insoles or the control group static condition - standard one-off instruction using a scale
The primary objective is to determine whether the proportion of steps exceeding the weight bearing limit is lower in the intervention group compared to the control group 2 weeks after surgery Secondary objectives include assessing subjective ratings of the permitted load perceived pain and mobility Additionally the trial hypothesizes that patients using the insoles can estimate applied load more accurately The intervention group will also provide feedback on the usability of the app and insoles
The results of this trial will contribute to enhancing postoperative treatment of patients undergoing orthopaedic surgery thereby improving treatment outcomes and optimizing therapy regimens
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None