Efficacy of STABL Virtual Rehabilitation: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in The Knee Injury and Osteoarthritis Outcome Score Pain Subscale
研究概览
简要总结
The purpose of the proposed study is to evaluate the efficacy of STABL rehabilitation vs in-person rehabilitation following meniscectomy or synovectomy. STABL is a digital health platform that uses computer-vision technology to facilitate at-home post-op recovery for patients while enabling remote monitoring by their surgeon.
详细描述
Patients undergoing minor knee procedures (defined as meniscectomy and synovectomy) will be randomized to virtual rehabilitation using the STABL platform or standard physical therapy over the course of 6 weeks to determine any possible difference in clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Underwent meniscectomy or synovectomy surgery
- •Age 18-65
- •Ability to comply with a standardized postoperative protocol
- •Willing and able to provide consent
排除标准
- •Previous knee surgery
- •Patients at any increased risk of falls or at increased risk from harm due to falling, including issues with vertigo, osteoporosis, or a history of past falls
- •Patient otherwise deemed at increased risk from this investigational rehabilitation program by their referring surgeon or physical therapist
- •Patients who are pregnant
研究组 & 干预措施
Rehabilitation using STABL platform
Patients undergoing minor knee procedures (defined as meniscectomy and synovectomy) will be randomized to virtual rehabilitation using the STABL platform
干预措施: STABL Virtual Rehabilitation (Behavioral)
Rehabilitation using standard physical therapy
Patients undergoing minor knee procedures (defined as meniscectomy and synovectomy) will be randomized to standard physical therapy.
结局指标
主要结局
Change in The Knee Injury and Osteoarthritis Outcome Score Pain Subscale
时间窗: Baseline, Month 12
Measured by the Pain Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Change in ACL-Return to Sport (ACL-RSI) Scale Score
时间窗: Baseline, Week 3
The ACL-RSI scale includes 12 questions on the patient's emotional well-being and confidence in his or her performance and risk appraisal. The scale, with scores ranging from 1 to 10, includes 5 questions on emotional well-being, 5 questions on confidence in physical performance, and 2 questions on the appraisal of risk. Higher scores indicate a more positive psychological response. The total score is determined by adding the values of the 12 responses and then calculating their relationship to 100 to obtain a percentage (0-100%).
Change in Visual Analogue Scale (VAS) Pain score
时间窗: Baseline, Month 12
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Change in The Knee Injury and Osteoarthritis Outcome Score Function/daily living Subscale
时间窗: Baseline, , Month 12
Measured by the function/daily living Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Change in Active Range of Motion (AROM)
时间窗: Baseline, Month 12
AROM is measured using a goniometer (protractor that measures joint angles) to see how much the knee can bend and straighten on its own (without assistance). Normal ROM at the knee is considered to be 0 degrees of extension (completely straight knee joint) to 135 degrees of flexion (fully bent knee joint).
Change in Passive Range of Motion (PROM)
时间窗: Baseline, Month 12
PROM is measured using a goniometer (protractor that measures joint angles) to see how far the knee can bend and straighten when moved by an external force. Normal ROM at the knee is considered to be 0 degrees of extension (completely straight knee joint) to 135 degrees of flexion (fully bent knee joint).
Change in The Knee Injury and Osteoarthritis Outcome Score Symptoms Subscale
时间窗: Baseline, Month 12
Measured by the Symptoms Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Change in The Knee Injury and Osteoarthritis Outcome Score Function/sports and recreational activities Subscale
时间窗: Baseline, Month 12
Measured by the function/sports and recreational activities Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Change in The Knee Injury and Osteoarthritis Outcome Score Quality of Life Subscale
时间窗: Baseline, Month 12
Measured by the Quality of life Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Change in The Knee Injury and Osteoarthritis Outcome Score Pain Subscale
时间窗: Baseline, Week 3
Measured by the Pain Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Change in The Knee Injury and Osteoarthritis Outcome Score Pain Subscale
时间窗: Baseline, Month 6
Measured by the Pain Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Change in Visual Analogue Scale (VAS) Pain score
时间窗: Baseline, Week 3
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Change in The Knee Injury and Osteoarthritis Outcome Score Symptoms Subscale
时间窗: Baseline, Week 3
Measured by the Symptoms Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Change in The Knee Injury and Osteoarthritis Outcome Score Symptoms Subscale
时间窗: Baseline, Month 6
Measured by the Symptoms Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Change in The Knee Injury and Osteoarthritis Outcome Score Function/sports and recreational activities Subscale
时间窗: Baseline, Week 3
Measured by the function/sports and recreational activities Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Change in The Knee Injury and Osteoarthritis Outcome Score Function/sports and recreational activities Subscale
时间窗: Baseline, Month 6
Measured by the function/sports and recreational activities Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Change in The Knee Injury and Osteoarthritis Outcome Score Quality of Life Subscale
时间窗: Baseline, Week 3
Measured by the Quality of life Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Change in The Knee Injury and Osteoarthritis Outcome Score Quality of Life Subscale
时间窗: Baseline, Month 6
Measured by the Quality of life Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Change in The Knee Injury and Osteoarthritis Outcome Score Function/daily living Subscale
时间窗: Baseline, Week 3
Measured by the function/daily living Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Change in The Knee Injury and Osteoarthritis Outcome Score Function/daily living Subscale
时间窗: Baseline, Month 6
Measured by the function/daily living Knee injury and osteoarthritis score subscales (KOOS subscales). The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Change in Visual Analogue Scale (VAS) Pain score
时间窗: Baseline, Month 6
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Change in Active Range of Motion (AROM)
时间窗: Baseline, Week 1
AROM is measured using a goniometer (protractor that measures joint angles) to see how much the knee can bend and straighten on its own (without assistance). Normal ROM at the knee is considered to be 0 degrees of extension (completely straight knee joint) to 135 degrees of flexion (fully bent knee joint).
Change in Active Range of Motion (AROM)
时间窗: Baseline, Week 3
AROM is measured using a goniometer (protractor that measures joint angles) to see how much the knee can bend and straighten on its own (without assistance). Normal ROM at the knee is considered to be 0 degrees of extension (completely straight knee joint) to 135 degrees of flexion (fully bent knee joint).
Change in Active Range of Motion (AROM)
时间窗: Baseline, Month 6
AROM is measured using a goniometer (protractor that measures joint angles) to see how much the knee can bend and straighten on its own (without assistance). Normal ROM at the knee is considered to be 0 degrees of extension (completely straight knee joint) to 135 degrees of flexion (fully bent knee joint).
Change in Passive Range of Motion (PROM)
时间窗: Baseline, Week 1
PROM is measured using a goniometer (protractor that measures joint angles) to see how far the knee can bend and straighten when moved by an external force. Normal ROM at the knee is considered to be 0 degrees of extension (completely straight knee joint) to 135 degrees of flexion (fully bent knee joint).
Change in Passive Range of Motion (PROM)
时间窗: Baseline, Week 4-6
PROM is measured using a goniometer (protractor that measures joint angles) to see how far the knee can bend and straighten when moved by an external force. Normal ROM at the knee is considered to be 0 degrees of extension (completely straight knee joint) to 135 degrees of flexion (fully bent knee joint).
Change in Passive Range of Motion (PROM)
时间窗: Baseline, Month 6
PROM is measured using a goniometer (protractor that measures joint angles) to see how far the knee can bend and straighten when moved by an external force. Normal ROM at the knee is considered to be 0 degrees of extension (completely straight knee joint) to 135 degrees of flexion (fully bent knee joint).
次要结局
未报告次要终点