Knee OsteoarthritisWESENS-OANCT04243096
Wearable Sensors in Knee OA
A study testing Exercise-based Physical Therapy in people with Knee Osteoarthritis, run by Boston University Charles River Campus at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Exercise-based Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2020to 4 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wearable Sensor-based Outcomes Following Physical Therapy in Knee Osteoarthritis: A Feasibility Study (WESENS-OA)
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Exercise-based Physical Therapy
- Keywords
- physical therapy, wearable sensors, gait, pain sensitization, physical activity
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise-based Physical TherapyBehavioural
Also called Exercise
Exercises for pain modulation, strengthening, and neuromuscular control
| Study group | Role | What they receive |
|---|---|---|
| Exercise-based Physical Therapy | Experimental | 12 week in-person exercise-based physical therapy Receives: Behavioral: Exercise-based Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensor Derived Cadence
number of steps/min during the clinic-based 28-meter walk test from lower back sensor
Measured: Change from baseline to 12 weeks
Sensor Derived Stride Duration
duration of one stride during gait (sec) during the clinic-based 28-meter walk test
Measured: Change from baseline to 12 weeks
Sensor Derived Step Duration
duration of one step during gait (sec) during the clinic-based 28-meter walk test from lower back sensor
Measured: Change from baseline to 12 weeks
Sensor Derived Stance Time
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
Measured: Change from baseline to 12 weeks
Sensor Derived Total Double Support Time
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
Measured: Change from baseline to 12 weeks
Sensor Derived Swing Time
duration of swing phase during gait (sec) during the clinic-based 28-meter walk test from lower back sensor
Measured: Change from baseline to 12 weeks
Sensor Derived Single Limb Support Time
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
Measured: Change from baseline to 12 weeks
Sensor Derived Step Length
length of a step during gait (m) during the clinic-based 28-meter walk test from lower back sensor
Measured: Change from baseline to 12 weeks
Sensor Derived Gait Speed
walking speed (m/s) during the clinic-based 28-meter walk test from lower back sensor
Measured: Change from baseline to 12 weeks
Sensor Derived Duration of Sit to Stand
time taken to complete a chair stand (sec) from lower back sensor
Measured: Change from baseline to 12 weeks
Sensor Derived Sit to Stand Acceleration
peak acceleration during chair stand (m/s^2) from lower back sensor
Measured: Change from baseline to 12 weeks
Sensor Derived Sit to Stand Deceleration
peak deceleration during chair stand (m/s^2) from lower back sensor
Measured: Change from baseline to 12 weeks
Secondary outcomes (15)
Physical Function (KOOS ADL)
Knee injury and Osteoarthritis Outcome Scale ADL Score (0-100, higher score indicate better outcome)
Measured: Change from baseline to 12 weeks
Knee Pain (KOOS Pain)
Knee injury and Osteoarthritis Outcome Scale Pain Score (0-100, higher score indicate better outcome)
Measured: Change from baseline to 12 weeks
Moderate to Vigorous Physical Activity (MVPA)
time spent in moderate and vigorous intensity activity per day extracted from a wrist worn sensor (GT9X Link)
Measured: Change from baseline to 12 weeks
Time Taken to Complete 28-meter Walk Test
time taken to complete 28-meter walk test (s) from stopwatch during the clinic-based 28-meter walk test
Measured: Change from baseline to 12 weeks
First Peak of Knee Index
Knee loading index for study knee during walking at self-selected pace from 3D motion capture (%Bodyweight*height)
Measured: Change from baseline to 12 weeks
Knee Co-contraction
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.
Measured: Change from baseline to 12 weeks
Knee Frontal Plane Excursion
abduction-adduction range during stance phase of gait measured using 3D motion capture (degrees)
Measured: Change from baseline to 12 weeks
Knee Sagittal Plane Excursion
flexion-extension range for study knee during stance phase of gait measured during walking at self-selected pace using 3D motion capture (degrees)
Measured: Change from baseline to 12 weeks
Trunk Angle
peak trunk forward flexion angle during sit-to-stand measured using 3D motion capture (degrees)
Measured: Change from baseline to 12 weeks
Global Assessment
Patient Global Assessment of OA (PGA-OA) (range 0-100, higher score indicates better outcome)
Measured: Change from baseline to 12 weeks
Step Up Test
number of step ups completed in 15 seconds
Measured: Change from baseline to 12 weeks
Stair Climbing Test (SCT)
Time taken to go up and down a flight of stairs (sec)
Measured: Change from baseline to 12 weeks
Short Physical Performance Battery (SPPB)
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.
Measured: Change from baseline to 12 weeks
6-minute Walk Test (6MWT)
distance covered walking in 6 minutes (m)
Measured: Change from baseline to 12 weeks
5-time Sit to Stand (5STS)
time taken to complete 5 chair stands (sec)
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start21 Jan 2020
- Primary completion4 Nov 2022
- Study completion4 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm interventional study
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, Pfizer, Eli Lilly and Company
- Responsible party
- Principal investigator, Deepak Kumar, Boston University Charles River Campus
- Investigators
- Deepak Kumar, PT, PhD, Principal investigator, Boston UniversityTuhina Neogi, MD, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243096
- Sponsor's protocol ID
- 5540E
- Acronym
- WESENS-OA
- Status last verified
- Jun 2024
- First submitted
- 14 Jan 2020
- Last updated
- 26 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in publication(s), after deidentification.
Publications
Lee S, Neogi T, Costello KE, Senderling B, Stefanik JJ, Frey-Law L, Kumar D. Association of mechanical temporal summation of pain with muscle co-contraction during walking in people with knee osteoarthritis. Clin Biomech (Bristol). 2023 Dec;110:106105. doi: 10.1016/j.clinbiomech.2023.106105. Epub 2023 Sep 22.
PubMed 37778085Rose MJ, Neogi T, Friscia B, Torabian KA, LaValley MP, Gheller M, Adamowicz L, Georgiev P, Viktrup L, Demanuele C, Wacnik PW, Kumar D. Reliability of Wearable Sensors for Assessing Gait and Chair Stand Function at Home in People With Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2023 Sep;75(9):1939-1948. doi: 10.1002/acr.25096. Epub 2023 Mar 7.
PubMed 36734316
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Sensor-based Outcomes Following Physical Therapy in Knee Osteoarthritis: A Feasibility Study (WESENS-OA)
- ClinicalTrials.gov ID
- NCT04243096
- Acronym / sponsor ID
- WESENS-OA / 5540E
- Conditions
- Knee Osteoarthritis
- Keywords
- physical therapy, wearable sensors, gait, pain sensitization, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- Boston University, Pfizer, Eli Lilly and Company
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Posted 26 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm interventional study
| Arm | Type | Receives |
|---|---|---|
| Exercise-based Physical Therapy | Experimental | Behavioral: Exercise-based Physical Therapy12 week in-person exercise-based physical therapy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise-based Physical TherapyAlso: ExerciseExercises for pain modulation, strengthening, and neuromuscular control | Behavioural | Exercise-based Physical Therapy |
Primary outcome
Sensor Derived Cadence
Time frame: Change from baseline to 12 weeks
number of steps/min during the clinic-based 28-meter walk test from lower back sensor
Sensor Derived Stride Duration
Time frame: Change from baseline to 12 weeks
duration of one stride during gait (sec) during the clinic-based 28-meter walk test
Sensor Derived Step Duration
Time frame: 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 Stance Time
Time frame: 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 Total Double Support Time
Time frame: 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 Swing Time
Time frame: 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 Single Limb Support Time
Time frame: 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 Step Length
Time frame: 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 Gait Speed
Time frame: Change from baseline to 12 weeks
walking speed (m/s) during the clinic-based 28-meter walk test from lower back sensor
Sensor Derived Duration of Sit to Stand
Time frame: Change from baseline to 12 weeks
time taken to complete a chair stand (sec) from lower back sensor
Sensor Derived Sit to Stand Acceleration
Time frame: Change from baseline to 12 weeks
peak acceleration during chair stand (m/s^2) from lower back sensor
Sensor Derived Sit to Stand Deceleration
Time frame: Change from baseline to 12 weeks
peak deceleration during chair stand (m/s^2) from lower back sensor
15 secondary outcomes
Physical Function (KOOS ADL)
Time frame: Change from baseline to 12 weeks
Knee Pain (KOOS Pain)
Time frame: Change from baseline to 12 weeks
Moderate to Vigorous Physical Activity (MVPA)
Time frame: Change from baseline to 12 weeks
Time Taken to Complete 28-meter Walk Test
Time frame: Change from baseline to 12 weeks
First Peak of Knee Index
Time frame: Change from baseline to 12 weeks
Knee Co-contraction
Time frame: Change from baseline to 12 weeks
Knee Frontal Plane Excursion
Time frame: Change from baseline to 12 weeks
Knee Sagittal Plane Excursion
Time frame: Change from baseline to 12 weeks
Trunk Angle
Time frame: Change from baseline to 12 weeks
Global Assessment
Time frame: Change from baseline to 12 weeks
Step Up Test
Time frame: Change from baseline to 12 weeks
Stair Climbing Test (SCT)
Time frame: Change from baseline to 12 weeks
Short Physical Performance Battery (SPPB)
Time frame: Change from baseline to 12 weeks
6-minute Walk Test (6MWT)
Time frame: Change from baseline to 12 weeks
5-time Sit to Stand (5STS)
Time frame: Change from baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37778085Lee S, Neogi T, Costello KE, Senderling B, Stefanik JJ, Frey-Law L, Kumar D. Association of mechanical temporal summation of pain with muscle co-contraction during walking in people with knee osteoarthritis. Clin Biomech (Bristol). 2023 Dec;110:106105. doi: 10.1016/j.clinbiomech.2023.106105. Epub 2023 Sep 22.
- Derived from this study: PubMed 36734316Rose MJ, Neogi T, Friscia B, Torabian KA, LaValley MP, Gheller M, Adamowicz L, Georgiev P, Viktrup L, Demanuele C, Wacnik PW, Kumar D. Reliability of Wearable Sensors for Assessing Gait and Chair Stand Function at Home in People With Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2023 Sep;75(9):1939-1948. doi: 10.1002/acr.25096. Epub 2023 Mar 7.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in publication(s), after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepak Kumar, PT, PhD principal investigator
Boston University
Tuhina Neogi, MD, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise-based Physical Therapy in people with Knee Osteoarthritis, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensor Derived Cadence (time frame: Change from baseline to 12 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04243096, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024; AzTrials last refreshed its copy on 31 Oct 2026.