Wearable Sensors in Knee OA

NCT04243096 | Completed Results

• 1 other identifier: 5540E
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

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

Outcome Measures

Primary Outcomes (12)

• Sensor Derived Cadence

  number of steps/min during the clinic-based 28-meter walk test from lower back sensor

  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

  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

  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

  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

  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

  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

  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

  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

  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

  Change from baseline to 12 weeks

• Sensor Derived Sit to Stand Acceleration

  peak acceleration during chair stand (m/s\^2) from lower back sensor

  Change from baseline to 12 weeks

• Sensor Derived Sit to Stand Deceleration

  peak deceleration during chair stand (m/s\^2) from lower back sensor

  Change from baseline to 12 weeks

Secondary Outcomes (15)

• Physical Function (KOOS ADL)

  Change from baseline to 12 weeks

• Knee Pain (KOOS Pain)

  Change from baseline to 12 weeks

• Moderate to Vigorous Physical Activity (MVPA)

  Change from baseline to 12 weeks

• Time Taken to Complete 28-meter Walk Test

  Change from baseline to 12 weeks

• First Peak of Knee Index

  Change from baseline to 12 weeks

Other Outcomes (15)

• Number of Sit to Stand

  Change from baseline to 12 weeks

• Gait Bouts

  Change from baseline to 12 weeks

• Total Sleep Time

  Change from baseline to 12 weeks

Study Arms (1)

Exercise-based Physical Therapy

EXPERIMENTAL

12 week in-person exercise-based physical therapy

Behavioral: Exercise-based Physical Therapy

Interventions

Exercise-based Physical Therapy BEHAVIORAL

Exercises for pain modulation, strengthening, and neuromuscular control

Also known as: Exercise

Exercise-based Physical Therapy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• Boston University: collaborator
• Pfizer: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

• 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.

  PMID: 37778085 DERIVED

• Rose 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.

  PMID: 36734316 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

All sensor-based results are preliminary. Further optimization of the algorithm is underway. Sensor-based measures for sit-to-stand were only available from a few participants and hence those data should be interpreted with caution. The serious adverse events were unrelated to the study participation.

Results Point of Contact

• Title: Deepak Kumar, PT, PhD
• Organization: Boston University

kumard@bu.edu

617-358-3037

Study Officials

• Deepak Kumar, PT, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

• Tuhina Neogi, MD, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Since this is a single-arm study, no masking is included.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single-arm interventional study

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 28, 2020
• Study Start: January 21, 2020
• Primary Completion: November 4, 2022
• Study Completion: November 4, 2022
• Last Updated: September 26, 2024
• Results First Posted: September 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following publication(s).
• Access Criteria: Data will only be shared for individual participant data meta-analyses. Data will be shared with investigators who propose a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee identified for this purpose.

Locations

US (1)