Trial Outcomes & Findings for Wearable Sensors in Knee OA (NCT NCT04243096)

NCT ID: NCT04243096

Last Updated: 2024-09-26

Results Overview

number of steps/min during the clinic-based 28-meter walk test from lower back sensor

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 62 participants
• Primary outcome timeframe: Change from baseline to 12 weeks
• Results posted on: 2024-09-26

Participant Flow

Participant milestones

Measure	Exercise-based Physical Therapy 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Overall Study STARTED	62
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Wearable Sensors in Knee OA

Baseline characteristics by cohort

Measure	Exercise-based Physical Therapy n=60 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Age, Continuous	66.3 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants
BMI	29.0 kg/m2 STANDARD_DEVIATION 4.8 • n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to 12 weeks

number of steps/min during the clinic-based 28-meter walk test from lower back sensor

Outcome measures

Measure	Exercise-based Physical Therapy n=56 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Sensor Derived Cadence	4.62 steps/min Interval 2.6 to 6.64

PRIMARY outcome

Timeframe: Change from baseline to 12 weeks

duration of one stride during gait (sec) during the clinic-based 28-meter walk test

Outcome measures

Measure	Exercise-based Physical Therapy n=56 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Sensor Derived Stride Duration	-0.04 second Interval -0.06 to -0.02

PRIMARY outcome

Timeframe: Change from baseline to 12 weeks

duration of one step during gait (sec) during the clinic-based 28-meter walk test from lower back sensor

Outcome measures

Measure	Exercise-based Physical Therapy n=56 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Sensor Derived Step Duration	-0.02 second Interval -0.03 to -0.01

PRIMARY outcome

Timeframe: Change from baseline to 12 weeks

Duration of stance phase (i.e., duration of time the foot is in contact with the ground in a step) during gait (sec) during the clinic-based 28-meter walk test from lower back sensor

Outcome measures

Measure	Exercise-based Physical Therapy n=56 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Sensor Derived Stance Time	-0.03 second Interval -0.04 to -0.02

PRIMARY outcome

Timeframe: Change from baseline to 12 weeks

time when both feet are on the ground in one gait cycle (sec) during the clinic-based 28-meter walk test from lower back sensor

Outcome measures

Measure	Exercise-based Physical Therapy n=56 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Sensor Derived Total Double Support Time	-0.01 seconds Interval -0.01 to 0.0

PRIMARY outcome

Timeframe: Change from baseline to 12 weeks

duration of swing phase during gait (sec) during the clinic-based 28-meter walk test from lower back sensor

Outcome measures

Measure	Exercise-based Physical Therapy n=56 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Sensor Derived Swing Time	-0.01 seconds Interval -0.02 to -0.01

PRIMARY outcome

Timeframe: Change from baseline to 12 weeks

time when one foot is on the ground in one gait cycle (sec) during the clinic-based 28-meter walk test from lower back sensor

Outcome measures

Measure	Exercise-based Physical Therapy n=56 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Sensor Derived Single Limb Support Time	-0.02 seconds Interval -0.02 to -0.01

PRIMARY outcome

Timeframe: Change from baseline to 12 weeks

length of a step during gait (m) during the clinic-based 28-meter walk test from lower back sensor

Outcome measures

Measure	Exercise-based Physical Therapy n=56 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Sensor Derived Step Length	0.03 meters Interval 0.02 to 0.04

PRIMARY outcome

Timeframe: Change from baseline to 12 weeks

walking speed (m/s) during the clinic-based 28-meter walk test from lower back sensor

Outcome measures

Measure	Exercise-based Physical Therapy n=56 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Sensor Derived Gait Speed	0.09 m/s Interval 0.06 to 0.13

PRIMARY outcome

Timeframe: Change from baseline to 12 weeks

Population: these data were only available from a few participants due to issues with the algorithm

time taken to complete a chair stand (sec) from lower back sensor

Outcome measures

Measure	Exercise-based Physical Therapy n=6 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Sensor Derived Duration of Sit to Stand	0.20 seconds Interval -0.41 to 0.8

PRIMARY outcome

Timeframe: Change from baseline to 12 weeks

Population: these data were only available from a few participants due to issues with the algorithm

peak acceleration during chair stand (m/s^2) from lower back sensor

Outcome measures

Measure	Exercise-based Physical Therapy n=6 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Sensor Derived Sit to Stand Acceleration	0.10 meters per second squared Interval -1.62 to 1.81

PRIMARY outcome

Timeframe: Change from baseline to 12 weeks

Population: these data were only available from a few participants due to issues with the algorithm

peak deceleration during chair stand (m/s^2) from lower back sensor

Outcome measures

Measure	Exercise-based Physical Therapy n=6 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Sensor Derived Sit to Stand Deceleration	-0.33 meters per second squared Interval -2.94 to 2.27

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

Knee injury and Osteoarthritis Outcome Scale ADL Score (0-100, higher score indicate better outcome)

Outcome measures

Measure	Exercise-based Physical Therapy n=55 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Physical Function (KOOS ADL)	9.96 score on a scale Interval 6.6 to 13.31

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

Knee injury and Osteoarthritis Outcome Scale Pain Score (0-100, higher score indicate better outcome)

Outcome measures

Measure	Exercise-based Physical Therapy n=55 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Knee Pain (KOOS Pain)	13.07 score on a scale Interval 9.65 to 16.48

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

time spent in moderate and vigorous intensity activity per day extracted from a wrist worn sensor (GT9X Link)

Outcome measures

Measure	Exercise-based Physical Therapy n=53 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Moderate to Vigorous Physical Activity (MVPA)	-17.5 minutes Interval -39.7 to 4.61

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

time taken to complete 28-meter walk test (s) from stopwatch during the clinic-based 28-meter walk test

Outcome measures

Measure	Exercise-based Physical Therapy n=58 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Time Taken to Complete 28-meter Walk Test	-3.23 second Interval -4.33 to -2.12

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

Knee loading index for study knee during walking at self-selected pace from 3D motion capture (%Bodyweight*height)

Outcome measures

Measure	Exercise-based Physical Therapy n=40 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
First Peak of Knee Index	0.11 %Newton*meter Interval -0.04 to 0.25

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

Peak medial quadriceps-medial hamstrings co-contraction during loading response during walking at self-selected pace. Higher values reflect greater co-activation of these muscles.

Outcome measures

Measure	Exercise-based Physical Therapy n=40 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Knee Co-contraction	-1.83 arbitrary units Interval -5.76 to 2.09

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

abduction-adduction range during stance phase of gait measured using 3D motion capture (degrees)

Outcome measures

Measure	Exercise-based Physical Therapy n=58 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Knee Frontal Plane Excursion	-0.15 Degrees Interval -0.46 to 0.16

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

flexion-extension range for study knee during stance phase of gait measured during walking at self-selected pace using 3D motion capture (degrees)

Outcome measures

Measure	Exercise-based Physical Therapy n=58 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Knee Sagittal Plane Excursion	-1.15 degree Interval -2.22 to -0.08

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

peak trunk forward flexion angle during sit-to-stand measured using 3D motion capture (degrees)

Outcome measures

Measure	Exercise-based Physical Therapy n=55 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Trunk Angle	-0.08 degree Interval -3.37 to 3.22

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

Patient Global Assessment of OA (PGA-OA) (range 0-100, higher score indicates better outcome)

Outcome measures

Measure	Exercise-based Physical Therapy n=54 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Global Assessment	6.21 score on a scale Interval 1.31 to 11.11

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

number of step ups completed in 15 seconds

Outcome measures

Measure	Exercise-based Physical Therapy n=58 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Step Up Test	1.75 repetitions Interval 1.16 to 2.34

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

Time taken to go up and down a flight of stairs (sec)

Outcome measures

Measure	Exercise-based Physical Therapy n=57 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Stair Climbing Test (SCT)	-1.19 seconds Interval -1.97 to -0.41

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

Short Physical Performance Battery total score. This is a functional test where several different activities (e.g., balance, walking, getting up from a chair) are performed and scored by the examiner. The total score is the sum of scores across all of the activities. Range is 0-12. Higher scores reflect better physical function.

Outcome measures

Measure	Exercise-based Physical Therapy n=58 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Short Physical Performance Battery (SPPB)	0.45 score on a scale Interval 0.23 to 0.67

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

distance covered walking in 6 minutes (m)

Outcome measures

Measure	Exercise-based Physical Therapy n=58 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
6-minute Walk Test (6MWT)	35.18 meters Interval 18.7 to 51.67

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

time taken to complete 5 chair stands (sec)

Outcome measures

Measure	Exercise-based Physical Therapy n=57 Participants 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
5-time Sit to Stand (5STS)	-1.98 seconds Interval -2.57 to -1.39

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to 12 weeks

number of chair stands per day measured using lumbar sensor

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to 12 weeks

number of gait bouts per day measured using lumbar sensor

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to 12 weeks

total sleep time per day measured using wrist-worn sensor (minutes)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to 12 weeks

Daily Sleep Interference Scale (DSIS) (0-10 numeric rating scale, higher number indicates greater interference in sleep due to pain)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to 12 weeks

peak extensor muscle torque from isometric strength testing (Nm/kg)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to 12 weeks

pressure at which pain is initially felt (kg/m2)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to 12 weeks

presence of wind up phenomenon in response to multiple pressure stimuli (yes/no)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to 12 weeks

reduction in pain sensitivity with application of second pain stimulus (yes/no)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to 12 weeks

Numeric rating scale for pain (0-10, higher score indicates worse pain)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to 12 weeks

Numeric rating scale for pain during nominated activity (0-10, higher score indicates worse pain)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to 12 weeks

Knee injury and osteoarthritis outcome score Symptoms scale (0-100, higher scores indicates better outcome)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to 12 weeks

Knee injury and osteoarthritis outcome score quality of life scale (0-100, higher scores indicates better outcome)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to 12 weeks

Knee injury and osteoarthritis outcome score sports/recreation scale (0-100, higher scores indicates better outcome)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to 12 weeks

Center for Epidemiologic Studies Depression Scale (range 0-60, higher score indicate more depressive symptoms)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to 12 weeks

number of painful joints in the body

Outcome measures

Outcome data not reported

Adverse Events

Exercise-based Physical Therapy

Serious events: 2 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Measure	Exercise-based Physical Therapy n=60 participants at risk 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Cardiac disorders Cardiac Arrest	1.7% 1/60 • Number of events 1 • 1 year, 10months
Surgical and medical procedures Spinal Tumor	1.7% 1/60 • Number of events 1 • 1 year, 10months

Other adverse events

Measure	Exercise-based Physical Therapy n=60 participants at risk 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control
Skin and subcutaneous tissue disorders Skin Irritation	6.7% 4/60 • Number of events 4 • 1 year, 10months

Additional Information

Deepak Kumar, PT, PhD

Boston University

Phone: 617-358-3037

Email: kumard@bu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place