University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Location status: Recruiting
Location contact
Carla Hill, DPT
SUB_INVESTIGATOR
Joe M Hart, PhD
CONTACT
Joe M Hart, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06090097
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.
Interested in participating?
Request Info30 year–75 year
All sexes
Interventional
Not applicable
Chapel Hill, North Carolina, 27599, United States
Location status: Recruiting
Carla Hill, DPT
SUB_INVESTIGATOR
Joe M Hart, PhD
CONTACT
Joe M Hart, PhD
PRINCIPAL_INVESTIGATOR
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 PT's 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The KneeBRIGHT system includes electromyogram sensors and video game software that leads participants through physical therapy exercise.
The control group will complete a 10-week regimen of conventional PT exercise
Time frame: After 10 weeks (study completion)
A multi-dimensional assessment that classifies knee outcomes into five categories: pain, symptoms, activities of daily living (ADL), sport, and quality of life
Time frame: After 10 weeks (study completion)
In the timed up and go (TUG) test, subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again.
Time frame: After 10 weeks (study completion)
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.
Time frame: After 10 weeks (study completion)
Quadriceps strength will be measured by recording isokinetic knee extension torque as measured by a dynamometer
Time frame: After 10 weeks (study completion)
The Patient Activation Model (PAM) is an established, highly reliable, questionnaire that reflects a developmental model of patient engagement with their healthcare regimens
Time frame: After 10 weeks (study completion)
Participants will complete a questionnaire, designed based on the established Technology Acceptance Model to assess their level of technology acceptance.
Time frame: After 10 weeks (study completion)
The KneeBRIGHT software will log the exercises completed at home; these logs will report number of exercises conducted, level of resistance, and timestamps for the sessions. Control group participants will log home exercises using a written checklist of exercises
Contact information is provided by the study sponsor or research team.
Barron Associates, Inc.
Industry
Knee-Biofeedback Rehabilitation Interface for Game-based Home Therapy
Acronym: KneeBRIGHT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05495334
Arthritis, Joint Diseases
Phoenix, Arizona, United States
View Trial DetailsNCT07721116
Arthritis, Artificial Intelligence
Taipei, Taiwan
View Trial DetailsNCT06507046
Arthritis, Joint Diseases
Kristiansund, Møre and Romsdal, Norway
View Trial DetailsNCT07484594
Arthritis, Joint Diseases
Islamabad, AL, Pakistan
View Trial Details