N/A
N=62
Wearable Sensors in Knee OA
Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT04243096 ↗Enrolled (actual)
62
Serious AEs
3.3%
Results posted
Sep 2024
Primary outcome: Primary: Sensor Derived Cadence — 4.62 steps/min — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise-based Physical Therapy (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Boston University Charles River Campus
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensor Derived Cadence |
4.62 | <0.0001 sig |
| PRIMARY Sensor Derived Stride Duration |
-0.04 | <0.0001 sig |
| PRIMARY Sensor Derived Step Duration |
-0.02 | <0.0001 sig |
| PRIMARY Sensor Derived Stance Time |
-0.03 | <0.0001 sig |
| PRIMARY Sensor Derived Total Double Support Time |
-0.01 | <0.0001 sig |
| PRIMARY Sensor Derived Swing Time |
-0.01 | 0.0013 sig |
| PRIMARY Sensor Derived Single Limb Support Time |
-0.02 | 0.0003 sig |
| PRIMARY Sensor Derived Step Length |
0.03 | <0.0001 sig |
| PRIMARY Sensor Derived Gait Speed |
0.09 | <0.0001 sig |
| PRIMARY Sensor Derived Duration of Sit to Stand |
0.20 | — |
| PRIMARY Sensor Derived Sit to Stand Acceleration |
0.10 | — |
| PRIMARY Sensor Derived Sit to Stand Deceleration |
-0.33 | — |
| SECONDARY Physical Function (KOOS ADL) |
9.96 | <0.0001 sig |
| SECONDARY Knee Pain (KOOS Pain) |
13.07 | <0.0001 sig |
| SECONDARY Moderate to Vigorous Physical Activity (MVPA) |
-17.5 | 0.1196 |
| SECONDARY Time Taken to Complete 28-meter Walk Test |
-3.23 | — |
| SECONDARY First Peak of Knee Index |
0.11 | <0.0001 sig |
| SECONDARY Knee Co-contraction |
-1.83 | <0.0001 sig |
| SECONDARY Knee Frontal Plane Excursion |
-0.15 | <0.0001 sig |
| SECONDARY Knee Sagittal Plane Excursion |
-1.15 | <0.0001 sig |
| SECONDARY Trunk Angle |
-0.08 | <0.0001 sig |
| SECONDARY Global Assessment |
6.21 | 0.0134 sig |
| SECONDARY Step Up Test |
1.75 | <0.0001 sig |
| SECONDARY Stair Climbing Test (SCT) |
-1.19 | 0.0030 sig |
| SECONDARY Short Physical Performance Battery (SPPB) |
0.45 | <0.0001 sig |
| SECONDARY 6-minute Walk Test (6MWT) |
35.18 | <0.0001 sig |
| SECONDARY 5-time Sit to Stand (5STS) |
-1.98 | <0.0001 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04243096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.