Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05876208
Status:
RECRUITING
Last Update Posted:
2023-05-25
First Post:
2023-05-16
Brief Title:
Increased Home-based Physical Therapy Adherence Using BAND Connects VirtuaCare Platform
Sponsor:
University of Cincinnati
Organization:
University of Cincinnati
Study Overview
Official Title:
Measuring the Effectiveness of BAND Connects VirtuaCare Asynchronous Telerehabilitation Platform in Increasing Patient Adherence for Total Shoulder Arthroplasty and Rotator Cuff Repair Physical Therapy Rehabilitatio
Status:
RECRUITING
Status Verified Date:
2023-05
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:
This study aims to enhance at-home therapy by introducing a new device called the BAND Connects VirtuaCare platform The study aims to determine whether patients can improve their adherence to at-home exercises using this device Currently research indicates that only 35 of patients undergoing physical therapy treatment fully comply with their prescribed plans of care often neglecting their at-home exercises To address this issue a set of smart exercise tools called VirtuaCare has been developed This platform provides patients with instructions on performing at-home exercises and offers real-time biofeedback to help them adjust their form if necessary The study seeks to evaluate the effectiveness of BAND CVCP in assisting patients and improving their overall success with at-home therapy
Detailed Description:
This study aims to compare the effectiveness of the BAND CVCP device with the standard physical therapy regimens provided by UC Health Orthopaedic Surgery Participants undergoing shoulder surgeries performed by Dr Brian Grawe will be randomly assigned to one of two groups Group 1 will utilize the BAND CVCP both in the clinic and at home as a supplement to their treatment protocols Group 2 will receive standard physical therapy without the BAND CVCP
In Group 1 participants will be given access to the BAND CVCP and necessary materials during their first physical therapy appointment The physical therapist will guide them through exercises using the device recording their actions and providing real-time feedback The BAND CVCP app on their provided Android phone will offer instructions for each exercise eliminating the need to memorize the routine
During clinic visits Group 1 participants progress will be reviewed using the BAND CVCP participant report The report will display information such as completed exercises form pace range of motion and exertion which is measured by sensors in the BAND CVCP handles The therapist will help participants understand any corrections needed for their at-home exercises and make adjustments to their rehabilitation plan accordingly
Both Group 1 and Group 2 participants will complete patient report outcomes at different intervals including pre-operative scores weekly visual analog scale assessments and monthly assessments such as the Upper Extremity Functional Index UEFI or Quick Disabilities of Arm Shoulder and Hand QuickDASH Group 1 participants will complete these forms using the BAND CVCPs phone application while Group 2 participants will use paper copies at the clinic
Additional assessments will be conducted at the 3-month 6-month and discharge from care visits which include the ASES SST and EQ-5D-5L forms Group 1 participants will complete these assessments on the BAND CVCPs phone application while Group 2 participants will use paper copies at the clinic
This study aims to evaluate the effectiveness of the BAND CVCP device compared to standard physical therapy regimens and track participant rehabilitation outcomes throughout the process
In Group 1 participants will be given access to the BAND CVCP and necessary materials during their first physical therapy appointment The physical therapist will guide them through exercises using the device recording their actions and providing real-time feedback The BAND CVCP app on their provided Android phone will offer instructions for each exercise eliminating the need to memorize the routine
During clinic visits Group 1 participants progress will be reviewed using the BAND CVCP participant report The report will display information such as completed exercises form pace range of motion and exertion which is measured by sensors in the BAND CVCP handles The therapist will help participants understand any corrections needed for their at-home exercises and make adjustments to their rehabilitation plan accordingly
Both Group 1 and Group 2 participants will complete patient report outcomes at different intervals including pre-operative scores weekly visual analog scale assessments and monthly assessments such as the Upper Extremity Functional Index UEFI or Quick Disabilities of Arm Shoulder and Hand QuickDASH Group 1 participants will complete these forms using the BAND CVCPs phone application while Group 2 participants will use paper copies at the clinic
Additional assessments will be conducted at the 3-month 6-month and discharge from care visits which include the ASES SST and EQ-5D-5L forms Group 1 participants will complete these assessments on the BAND CVCPs phone application while Group 2 participants will use paper copies at the clinic
This study aims to evaluate the effectiveness of the BAND CVCP device compared to standard physical therapy regimens and track participant rehabilitation outcomes throughout the process
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