Wearable Sensor-based Outcomes Following Physical Therapy in Knee Osteoarthritis: A Feasibility Study (WESENS-OA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Sensor Derived Cadence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Since this is a single-arm study, no masking is included.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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
排除标准
- •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.
- •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.
研究组 & 干预措施
Exercise-based Physical Therapy
12 week in-person exercise-based physical therapy
干预措施: Exercise-based Physical Therapy (Behavioral)
结局指标
主要结局
Sensor Derived Cadence
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Change from baseline to 12 weeks
time taken to complete a chair stand (sec) from lower back sensor
Sensor Derived Sit to Stand Acceleration
时间窗: Change from baseline to 12 weeks
peak acceleration during chair stand (m/s\^2) from lower back sensor
Sensor Derived Sit to Stand Deceleration
时间窗: Change from baseline to 12 weeks
peak deceleration during chair stand (m/s\^2) from lower back sensor
次要结局
- 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)
- Knee Co-contraction(Change from baseline to 12 weeks)
- Knee Frontal Plane Excursion(Change from baseline to 12 weeks)
- Knee Sagittal Plane Excursion(Change from baseline to 12 weeks)
- Trunk Angle(Change from baseline to 12 weeks)
- Global Assessment(Change from baseline to 12 weeks)
- Step Up Test(Change from baseline to 12 weeks)
- Stair Climbing Test (SCT)(Change from baseline to 12 weeks)
- Short Physical Performance Battery (SPPB)(Change from baseline to 12 weeks)
- 6-minute Walk Test (6MWT)(Change from baseline to 12 weeks)
- 5-time Sit to Stand (5STS)(Change from baseline to 12 weeks)
研究者
Deepak Kumar
Assistant Professor
Boston University Charles River Campus