Wearable Sensors in Knee OA

Wearable Sensor-based Outcomes Following Physical Therapy in Knee Osteoarthritis: A Feasibility Study (WESENS-OA)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04243096

Acronym

WESENS-OA

Enrollment

Registered

2020-01-28

Start date

2020-01-21

Completion date

2022-11-04

Last updated

2024-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

physical therapy, wearable sensors, gait, pain sensitization, physical activity

Brief summary

This is a single-arm clinical trial to investigate the outcome of exercise-based physical therapy in people with knee osteoarthritis through the use of wearable sensors.

Detailed description

This is a longitudinal, single arm, 19-week study to investigate the utility of digital assessments to measure the efficacy of exercise-based physical therapy (PT) for reducing pain and improving function in people with knee osteoarthritis (OA). A total of 60 participants will be included. Participants will receive a supervised exercise-based PT for 12 weeks and will undergo multiple assessments of strength, balance, gait and joint movement while being monitored with a motion capture system and wrist and lumbar wearable sensors. Additionally, participants' activities will be monitored in the real world with the same wrist and lumbar wearable sensors. After completion of the PT program, participants will be monitored for an additional 6-week period to measure persistence of treatment effect. During that time, they will continue to follow an exercise program at home. The primary objective will be to measure the effect of exercise-based PT on functional performance and pain reduction using both patient reported outcomes questionnaires (PROs) and digital metrics obtained from the laboratory assessments and wearable sensors worn in the real world. Pain phenotyping questionnaires and quantitative sensory testing assessments will also be used to evaluate the effect of specific pain phenotypes in treatment response. A substudy will be undertaken to assess reproducibility of sensor-based measures during physical performance testing across at-home and in-lab implementation, as well as, reproducibility of these measures over repeated at-home implementation.

Interventions

BEHAVIORALExercise-based Physical Therapy

Exercises for pain modulation, strengthening, and neuromuscular control

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Masking description

Since this is a single-arm study, no masking is included.

Intervention model description

Single-arm interventional study

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* ≥ 50 years of age * A confirmed clinical diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria (confirmed by the participant's physician). * Score ≥ 3 on weight-bearing questions from the Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale in the index knee * BMI ≤ 40 kg/m2 * Able to walk without assisted devices (eg. cane or walker) for at least 20 minutes * Can speak and understand English * Available for the study duration

Exclusion criteria

* Contraindication to exercise * Other pain in lower back or legs that is greater than knee pain * Currently receiving chemotherapy or radiation therapy for cancer except non-melanoma skin cancer * History of other disease that may involve the index joint including inflammatory joint disease such as rheumatoid arthritis, seronegative spondyloarthropathy (eg, ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease related arthropathy), crystalline disease (eg, gout or pseudogout), lupus erythematosus, knee joint infections, Paget's disease affecting the knee, or knee joint tumors. * Any knee surgery in the previous 6 months * Previous knee osteotomy, uni-compartmental replacement, or total knee replacement in either knee * Joint replacement in either hip or ankle * Planned major treatment for knee OA (e.g., surgery, injections, physical therapy) during the study period * Planned major surgery in the next 6 months * Corticosteroid or hyaluronic acid injections in either knee in the previous 3 months * Neurological conditions that impacts motor functioning, for e.g., stroke, Parkinson's disease, Alzheimer's disease, Multiple Sclerosis, diabetic neuropathy, etc. * Pregnant * Received physical therapy for knee OA within past 6 months * Known or suspected non-compliance, drug or alcohol abuse * Participation in another clinical trial for treatment of any joint or muscle pain * Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigators.

Design outcomes

Primary

Measure	Time frame	Description
Sensor Derived Cadence	Change from baseline to 12 weeks	number of steps/min during the clinic-based 28-meter walk test from lower back sensor
Sensor Derived Sit to Stand Deceleration	Change from baseline to 12 weeks	peak deceleration during chair stand (m/s\^2) from lower back sensor
Sensor Derived Sit to Stand Acceleration	Change from baseline to 12 weeks	peak acceleration during chair stand (m/s\^2) from lower back sensor
Sensor Derived Duration of Sit to Stand	Change from baseline to 12 weeks	time taken to complete a chair stand (sec) from lower back sensor
Sensor Derived Gait Speed	Change from baseline to 12 weeks	walking speed (m/s) during the clinic-based 28-meter walk test from lower back sensor
Sensor Derived Step Length	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
Sensor Derived Single Limb Support Time	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
Sensor Derived Swing Time	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
Sensor Derived Total Double Support Time	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
Sensor Derived Stance Time	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
Sensor Derived Step Duration	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
Sensor Derived Stride Duration	Change from baseline to 12 weeks	duration of one stride during gait (sec) during the clinic-based 28-meter walk test

Secondary

Measure	Time frame	Description
Stair Climbing Test (SCT)	Change from baseline to 12 weeks	Time taken to go up and down a flight of stairs (sec)
Physical Function (KOOS ADL)	Change from baseline to 12 weeks	Knee injury and Osteoarthritis Outcome Scale ADL Score (0-100, higher score indicate better outcome)
Knee Pain (KOOS Pain)	Change from baseline to 12 weeks	Knee injury and Osteoarthritis Outcome Scale Pain Score (0-100, higher score indicate better outcome)
Moderate to Vigorous Physical Activity (MVPA)	Change from baseline to 12 weeks	time spent in moderate and vigorous intensity activity per day extracted from a wrist worn sensor (GT9X Link)
Knee Frontal Plane Excursion	Change from baseline to 12 weeks	abduction-adduction range during stance phase of gait measured using 3D motion capture (degrees)
Time Taken to Complete 28-meter Walk Test	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
First Peak of Knee Index	Change from baseline to 12 weeks	Knee loading index for study knee during walking at self-selected pace from 3D motion capture (%Bodyweight\*height)
Knee Co-contraction	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.
Knee Sagittal Plane Excursion	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)
Trunk Angle	Change from baseline to 12 weeks	peak trunk forward flexion angle during sit-to-stand measured using 3D motion capture (degrees)
Global Assessment	Change from baseline to 12 weeks	Patient Global Assessment of OA (PGA-OA) (range 0-100, higher score indicates better outcome)
Step Up Test	Change from baseline to 12 weeks	number of step ups completed in 15 seconds
Short Physical Performance Battery (SPPB)	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.
6-minute Walk Test (6MWT)	Change from baseline to 12 weeks	distance covered walking in 6 minutes (m)
5-time Sit to Stand (5STS)	Change from baseline to 12 weeks	time taken to complete 5 chair stands (sec)

Other

Measure	Time frame	Description
Sleep Interference	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)
Depressive Symptoms	Change from baseline to 12 weeks	Center for Epidemiologic Studies Depression Scale (range 0-60, higher score indicate more depressive symptoms)
Number of Painful Joints	Change from baseline to 12 weeks	number of painful joints in the body
Total Sleep Time	Change from baseline to 12 weeks	total sleep time per day measured using wrist-worn sensor (minutes)
Gait Bouts	Change from baseline to 12 weeks	number of gait bouts per day measured using lumbar sensor
S/R - KOOS S/R	Change from baseline to 12 weeks	Knee injury and osteoarthritis outcome score sports/recreation scale (0-100, higher scores indicates better outcome)
QOL - KOOS QOL	Change from baseline to 12 weeks	Knee injury and osteoarthritis outcome score quality of life scale (0-100, higher scores indicates better outcome)
Symptoms - KOOS Symptoms	Change from baseline to 12 weeks	Knee injury and osteoarthritis outcome score Symptoms scale (0-100, higher scores indicates better outcome)
Knee Pain During Nominated Activity	Change from baseline to 12 weeks	Numeric rating scale for pain during nominated activity (0-10, higher score indicates worse pain)
Knee Pain	Change from baseline to 12 weeks	Numeric rating scale for pain (0-10, higher score indicates worse pain)
Conditioned Pain Modulation (CPM)	Change from baseline to 12 weeks	reduction in pain sensitivity with application of second pain stimulus (yes/no)
Temporal Summation (TS)	Change from baseline to 12 weeks	presence of wind up phenomenon in response to multiple pressure stimuli (yes/no)
Pressure Pain Threshold (PPT)	Change from baseline to 12 weeks	pressure at which pain is initially felt (kg/m2)
Peak Extensor Isometric Torque	Change from baseline to 12 weeks	peak extensor muscle torque from isometric strength testing (Nm/kg)
Number of Sit to Stand	Change from baseline to 12 weeks	number of chair stands per day measured using lumbar sensor

Countries

United States

Participant flow

Participants by arm

Arm	Count
Exercise-based Physical Therapy 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control	60
Total	60

Baseline characteristics

Characteristic	Exercise-based Physical Therapy
Age, Continuous	66.3 years STANDARD_DEVIATION 7.4
BMI	29.0 kg/m2 STANDARD_DEVIATION 4.8
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	5 Participants
Race (NIH/OMB) Black or African American	3 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants
Race (NIH/OMB) White	50 Participants
Region of Enrollment United States	60 participants
Sex: Female, Male Female	45 Participants
Sex: Female, Male Male	15 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	1 / 60
other Total, other adverse events	4 / 60
serious Total, serious adverse events	2 / 60