ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
617-358-3037
- ≥ 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
- 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.
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Descriptive Information | |||||||||||
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Brief Title ICMJE | Wearable Sensors in Knee OA | ||||||||||
Official Title ICMJE | Wearable Sensor-based Outcomes Following Physical Therapy in Knee Osteoarthritis: A Feasibility Study (WESENS-OA) | ||||||||||
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. | ||||||||||
Study Type ICMJE | Interventional | ||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Single-arm interventional study Masking: None (Open Label)Masking Description: Since this is a single-arm study, no masking is included. Primary Purpose: Treatment
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Condition ICMJE | Knee Osteoarthritis | ||||||||||
Intervention ICMJE | Behavioral: Exercise-based Physical Therapy
Exercises for pain modulation, strengthening, and neuromuscular control Other Name: Exercise | ||||||||||
Study Arms ICMJE | Experimental: Exercise-based Physical Therapy
12 week in-person exercise-based physical therapy Intervention: Behavioral: Exercise-based Physical Therapy | ||||||||||
Publications * | Not Provided | ||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||||
Recruitment Information | |||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||
Estimated Enrollment ICMJE | 60 | ||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||
Estimated Study Completion Date ICMJE | August 31, 2022 | ||||||||||
Estimated Primary Completion Date | May 31, 2022 (Final data collection date for primary outcome measure) | ||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years and older (Adult, Older Adult) | ||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||
Removed Location Countries | |||||||||||
Administrative Information | |||||||||||
NCT Number ICMJE | NCT04243096 | ||||||||||
Other Study ID Numbers ICMJE | 5540E | ||||||||||
Has Data Monitoring Committee | No | ||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Deepak Kumar, Boston University Charles River Campus | ||||||||||
Study Sponsor ICMJE | Boston University Charles River Campus | ||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Boston University Charles River Campus | ||||||||||
Verification Date | December 2020 | ||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |