Trial Outcomes & Findings for Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy for Patients With Knee Osteoarthritis (NCT NCT04187092)
NCT ID: NCT04187092
Last Updated: 2023-02-21
Results Overview
The KOOS has 5 subscales: Symptoms, Pain, Sports, Activities of Daily Living (ADL) and quality of life (QOL). Each scale is expressed on a scale from 0-100 points where 100 = best perceived knee function and 0=worst perceived knee function. The outcome of this study is expressed as a change score from pre-post treatment where positive scores indicate an improvement on each KOOS subscale.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
KOOS scores will be measured at baseline, day 1 and at the end of intervention, at 12 weeks.
Results posted on
2023-02-21
Participant Flow
Randomized= 34
Excluded (n=4) Scheduling reasons=2 The patients refused participation because of pandemic= 2
Participant milestones
| Measure |
KneeBright Group
Participants in this group will perform exercises aimed to improve the muscle strength, balance and precision. Participants will perform exercises three times a week for 12 weeks. Each session will last for an hour. Some of the exercises will be performed with the KneeBright Device while playing a video game.
KneeBright Group: The KneeBRIGHT group will use KneeBright device which consists of an EMG biofeedback interface software that guides users through exercise routines. The wireless EMG sensors includes two small electrodes that will be made to stick to the quadriceps muscles both sides. KneeBRIGHT software features a virtual world wherein patients complete challenges controlling the in-game avatar with the EMG units during exercises specific to knee osteoarthritis rehabilitation.
The KneeBRIGHT software will incorporates a variety of exercises for strengthening the quadriceps and will employ algorithms based on the Daily Adjustable Progressive Resistance Exercise (DAPRE) technique, in which the quantity of repetitions performed in these sets is then used to determine the appropriate increase (or possibly decrease) in target resistance for the next sets/sessions.
|
Standard Rehabilitation Group
Participants in this group will perform exercises with the same focus and frequency. No exercises will be performed with the KneeBright device.
Standard Rehabilitation group: Participants in this group will undergo standard clinic based knee rehabilitation. Both groups will perform exact same exercises, however, no KneeBRIGHT device will be used in this group.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
KneeBright Group
Participants in this group will perform exercises aimed to improve the muscle strength, balance and precision. Participants will perform exercises three times a week for 12 weeks. Each session will last for an hour. Some of the exercises will be performed with the KneeBright Device while playing a video game.
KneeBright Group: The KneeBRIGHT group will use KneeBright device which consists of an EMG biofeedback interface software that guides users through exercise routines. The wireless EMG sensors includes two small electrodes that will be made to stick to the quadriceps muscles both sides. KneeBRIGHT software features a virtual world wherein patients complete challenges controlling the in-game avatar with the EMG units during exercises specific to knee osteoarthritis rehabilitation.
The KneeBRIGHT software will incorporates a variety of exercises for strengthening the quadriceps and will employ algorithms based on the Daily Adjustable Progressive Resistance Exercise (DAPRE) technique, in which the quantity of repetitions performed in these sets is then used to determine the appropriate increase (or possibly decrease) in target resistance for the next sets/sessions.
|
Standard Rehabilitation Group
Participants in this group will perform exercises with the same focus and frequency. No exercises will be performed with the KneeBright device.
Standard Rehabilitation group: Participants in this group will undergo standard clinic based knee rehabilitation. Both groups will perform exact same exercises, however, no KneeBRIGHT device will be used in this group.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy for Patients With Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
KneeBright Group
n=15 Participants
Participants in this group will perform exercises aimed to improve the muscle strength, balance and precision. Participants will perform exercises three times a week for 12 weeks. Each session will last for an hour. Some of the exercises will be performed with the KneeBright Device while playing a video game.
KneeBright Group: The KneeBRIGHT group will use KneeBright device which consists of an EMG biofeedback interface software that guides users through exercise routines. The wireless EMG sensors includes two small electrodes that will be made to stick to the quadriceps muscles both sides. KneeBRIGHT software features a virtual world wherein patients complete challenges controlling the in-game avatar with the EMG units during exercises specific to knee osteoarthritis rehabilitation.
The KneeBRIGHT software will incorporate a variety of exercises for strengthening the quadriceps and will employ algorithms based on the Daily Adjustable Progressive Resistance Exercise (DAPRE) technique, in which the quantity of repetitions performed in these sets is then used to determine the appropriate increase (or possibly decrease) in target resistance for the next sets/sessions.
|
Standard Rehabilitation Group
n=14 Participants
Participants in this group will perform exercises with the same focus and frequency. No exercises will be performed with the KneeBright device.
Standard Rehabilitation group: Participants in this group will undergo standard clinic based knee rehabilitation. Both groups will perform exact same exercises, however, no KneeBRIGHT device will be used in this group.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Age, Continuous
|
69.3 years
STANDARD_DEVIATION 4.9 • n=93 Participants
|
63.4 years
STANDARD_DEVIATION 6.5 • n=4 Participants
|
66.5 years
STANDARD_DEVIATION 6.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: KOOS scores will be measured at baseline, day 1 and at the end of intervention, at 12 weeks.The KOOS has 5 subscales: Symptoms, Pain, Sports, Activities of Daily Living (ADL) and quality of life (QOL). Each scale is expressed on a scale from 0-100 points where 100 = best perceived knee function and 0=worst perceived knee function. The outcome of this study is expressed as a change score from pre-post treatment where positive scores indicate an improvement on each KOOS subscale.
Outcome measures
| Measure |
KneeBright Group
n=15 Participants
Participants in this group will perform exercises aimed to improve the muscle strength, balance and precision. Participants will perform exercises three times a week for 12 weeks. Each session will last for an hour. Some of the exercises will be performed with the KneeBright Device while playing a video game.
KneeBright Group: The KneeBRIGHT group will use KneeBright device which consists of an EMG biofeedback interface software that guides users through exercise routines. The wireless EMG sensors includes two small electrodes that will be made to stick to the quadriceps muscles both sides. KneeBRIGHT software features a virtual world wherein patients complete challenges controlling the in-game avatar with the EMG units during exercises specific to knee osteoarthritis rehabilitation.
The KneeBRIGHT software will incorporate a variety of exercises for strengthening the quadriceps and will employ algorithms based on the Daily Adjustable Progressive Resistance Exercise (DAPRE) technique, in which the quantity of repetitions performed in these sets is then used to determine the appropriate increase (or possibly decrease) in target resistance for the next sets/sessions.
|
Standard Rehabilitation Group
n=14 Participants
Participants in this group will perform exercises with the same focus and frequency. No exercises will be performed with the KneeBright device.
Standard Rehabilitation group: Participants in this group will undergo standard clinic based knee rehabilitation. Both groups will perform exact same exercises, however, no KneeBRIGHT device will be used in this group.
|
|---|---|---|
|
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS Symptoms
|
3.3 score on a scale
Interval -0.8 to 7.4
|
8.9 score on a scale
Interval 4.7 to 13.2
|
|
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS Pain
|
4.6 score on a scale
Interval -2.2 to 11.5
|
9.7 score on a scale
Interval 2.6 to 16.8
|
|
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS ADL
|
6.4 score on a scale
Interval -0.9 to 13.6
|
11.2 score on a scale
Interval 3.7 to 18.8
|
|
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS Sports
|
8.7 score on a scale
Interval -1.0 to 18.4
|
16.4 score on a scale
Interval 6.4 to 26.5
|
|
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS QOL
|
9.2 score on a scale
Interval 1.9 to 16.5
|
9.8 score on a scale
Interval 2.3 to 17.4
|
SECONDARY outcome
Timeframe: Peak torque (muscle strength) will be measured at baseline, day 1 and at the end of intervention, at 12 weeks.Population: Data from 4 participants in the KneeBright group and 2 participants from the Standard Rehabilitation group were removed due to bad/unuseable strength data. Therefore, 11 in the kneebright group and 12 in the standard rehab group were included in this analysis.
Thigh muscle strength will be measured at baseline and follow up. Participants will be asked to perform thigh muscle (quadriceps / knee extension) contractions while measures of strength using a dynamometer (biodex system 4) are recorded. Participants will be asked to perform repeated, maximal muscle contractions to test knee extension muscle strength on the test limb (unilateral test, one thigh tested on each particiant). We recorded peak torque defined as the maximal torque achieved during knee extension contractions. The outcome score is expressed as a change in peak torque from pre-post treatment. Positive numbers indicate increases in strength.
Outcome measures
| Measure |
KneeBright Group
n=11 thighs
Participants in this group will perform exercises aimed to improve the muscle strength, balance and precision. Participants will perform exercises three times a week for 12 weeks. Each session will last for an hour. Some of the exercises will be performed with the KneeBright Device while playing a video game.
KneeBright Group: The KneeBRIGHT group will use KneeBright device which consists of an EMG biofeedback interface software that guides users through exercise routines. The wireless EMG sensors includes two small electrodes that will be made to stick to the quadriceps muscles both sides. KneeBRIGHT software features a virtual world wherein patients complete challenges controlling the in-game avatar with the EMG units during exercises specific to knee osteoarthritis rehabilitation.
The KneeBRIGHT software will incorporate a variety of exercises for strengthening the quadriceps and will employ algorithms based on the Daily Adjustable Progressive Resistance Exercise (DAPRE) technique, in which the quantity of repetitions performed in these sets is then used to determine the appropriate increase (or possibly decrease) in target resistance for the next sets/sessions.
|
Standard Rehabilitation Group
n=12 thighs
Participants in this group will perform exercises with the same focus and frequency. No exercises will be performed with the KneeBright device.
Standard Rehabilitation group: Participants in this group will undergo standard clinic based knee rehabilitation. Both groups will perform exact same exercises, however, no KneeBRIGHT device will be used in this group.
|
|---|---|---|
|
Change in Peak Torque of Thigh Muscles Strength Testing
Extension peak torque 90degree
|
0.11 Nm/kg
Interval -0.02 to 0.24
|
0.11 Nm/kg
Interval -0.02 to 0.23
|
|
Change in Peak Torque of Thigh Muscles Strength Testing
Extension peak torque 180 degree
|
0.07 Nm/kg
Interval -0.13 to 0.27
|
-0.06 Nm/kg
Interval -0.25 to 0.13
|
Adverse Events
KneeBright Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Rehabilitation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place