Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06090097
Status:
RECRUITING
Last Update Posted:
2023-10-19
First Post:
2023-10-13
Brief Title:
Knee Biofeedback Rehabilitation Through Game Therapy
Sponsor:
Barron Associates Inc
Organization:
Barron Associates Inc
Study Overview
Official Title:
Knee-Biofeedback Rehabilitation Interface for Game-based Home Therapy
Status:
RECRUITING
Status Verified Date:
2024-10
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:
KneeBRIGHT
Brief Summary:
The goal of this study is to learn about the effect of video-game based rehabilitation exercise for patients with knee osteoarthritis The main question the study aims to answer is do patients who exercise with the game have better functional outcomes and engagement compared to patients who do conventional exercise Participants will complete 10 weeks of physical therapy exercise sessions that focus on quadriceps strengthening Two sessions per week will be conducted in the clinic and one session will be conducted at home each week The interventional group will conduct all exercises using the KneeBRIGHT EMG sensors and game software The control group will conduct all exercises following a standard physical therapy regimen Researchers will compare knee function and engagement between the group who uses the game and the group who does conventional exercise
Detailed Description:
The KneeBRIGHT game system will be evaluated in a 10-week single-blinded randomized controlled trial The goals of this study are to 1 assess improvements in functional outcomes following an exercise regimen conducted by KneeBRIGHT compared to conventional exercise and 2 evaluate patient engagement during unsupervised home-based exercises with and without the KneeBRIGHT software Over the course of the study period the knee OA participants will conduct physical therapy sessions with the physical therapist PT who enrolled them The exercise regimen will implement each PTs standard of care consisting of two weekly clinic sessions and one weekly home exercise session for 10 weeks Knee OA participants will be randomly assigned via block randomization for each PT to use either the KneeBRIGHT system for both clinic and home exercise or to receive standard care with conventional exercise routines Participants will conduct functional exercise assessments on study intake and again on study completion Participants will also complete questionnaires focused on exercise engagement on study completion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None