Clinical trial NCT04243096: Wearable Sensors in Knee OA
Official title: Wearable Sensor-based Outcomes Following Physical Therapy in Knee Osteoarthritis: A Feasibility Study (WESENS-OA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: physical therapy
wearable sensors
gait
pain sensitization
physical activity
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: Boston University
name: Pfizer
name: Eli Lilly and Company
First posted: 2020-01-28
Enrollment: 62
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm interventional study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensor Derived Cadence
timeFrame: Change from baseline to 12 weeks
measure: Sensor Derived Stride Duration
timeFrame: Change from baseline to 12 weeks
measure: Sensor Derived Step Duration
timeFrame: Change from baseline to 12 weeks
measure: Sensor Derived Stance Time
timeFrame: Change from baseline to 12 weeks
measure: Sensor Derived Total Double Support Time
timeFrame: Change from baseline to 12 weeks
measure: Sensor Derived Swing Time
timeFrame: Change from baseline to 12 weeks
measure: Sensor Derived Single Limb Support Time
timeFrame: Change from baseline to 12 weeks
measure: Sensor Derived Step Length
timeFrame: Change from baseline to 12 weeks
measure: Sensor Derived Gait Speed
timeFrame: Change from baseline to 12 weeks
measure: Sensor Derived Duration of Sit to Stand
timeFrame: Change from baseline to 12 weeks
measure: Sensor Derived Sit to Stand Acceleration
timeFrame: Change from baseline to 12 weeks
measure: Sensor Derived Sit to Stand Deceleration
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Physical Function (KOOS ADL)
timeFrame: Change from baseline to 12 weeks
measure: Knee Pain (KOOS Pain)
timeFrame: Change from baseline to 12 weeks
measure: Moderate to Vigorous Physical Activity (MVPA)
timeFrame: Change from baseline to 12 weeks
measure: Time Taken to Complete 28-meter Walk Test
timeFrame: Change from baseline to 12 weeks
measure: First Peak of Knee Index
timeFrame: Change from baseline to 12 weeks
measure: Knee Co-contraction
timeFrame: Change from baseline to 12 weeks
measure: Knee Frontal Plane Excursion
timeFrame: Change from baseline to 12 weeks
measure: Knee Sagittal Plane Excursion
timeFrame: Change from baseline to 12 weeks
measure: Trunk Angle
timeFrame: Change from baseline to 12 weeks
measure: Global Assessment
timeFrame: Change from baseline to 12 weeks
measure: Step Up Test
timeFrame: Change from baseline to 12 weeks
measure: Stair Climbing Test (SCT)
timeFrame: Change from baseline to 12 weeks
measure: Short Physical Performance Battery (SPPB)
timeFrame: Change from baseline to 12 weeks
measure: 6-minute Walk Test (6MWT)
timeFrame: Change from baseline to 12 weeks
measure: 5-time Sit to Stand (5STS)
timeFrame: Change from baseline to 12 weeks
Other outcomes:
measure: Number of Sit to Stand
timeFrame: Change from baseline to 12 weeks
measure: Gait Bouts
timeFrame: Change from baseline to 12 weeks
measure: Total Sleep Time
timeFrame: Change from baseline to 12 weeks
measure: Sleep Interference
timeFrame: Change from baseline to 12 weeks
measure: Peak Extensor Isometric Torque
timeFrame: Change from baseline to 12 weeks
measure: Pressure Pain Threshold (PPT)
timeFrame: Change from baseline to 12 weeks
measure: Temporal Summation (TS)
timeFrame: Change from baseline to 12 weeks
measure: Conditioned Pain Modulation (CPM)
timeFrame: Change from baseline to 12 weeks
measure: Knee Pain
timeFrame: Change from baseline to 12 weeks
measure: Knee Pain During Nominated Activity
timeFrame: Change from baseline to 12 weeks
measure: Symptoms - KOOS Symptoms
timeFrame: Change from baseline to 12 weeks
measure: QOL - KOOS QOL
timeFrame: Change from baseline to 12 weeks
measure: S/R - KOOS S/R
timeFrame: Change from baseline to 12 weeks
measure: Depressive Symptoms
timeFrame: Change from baseline to 12 weeks
measure: Number of Painful Joints
timeFrame: Change from baseline to 12 weeks
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Deepak Kumar, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Tuhina Neogi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: