Home-based Digital Program for Musculoskeletal Disorders: a Large-scale, Multi-disorder, Prospective, Single-arm, Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48,774
- 试验地点
- 1
- 主要终点
- Neck Disability Index
研究概览
简要总结
The purpose of this study is to assess the acceptance, engagement and outcomes of a digital care program for acute and chronic musculoskeletal conditions affecting the shoulder, elbow, hip, knee, ankle and spine.
详细描述
SWORD Health has developed a novel digital biofeedback system for home-based physical rehabilitation - SWORD Phoenix- which is an FDA-listed class I medical device. The company has previously conducted two pilot studies (NCT03047252; NCT03045549) comparing a digital rehabilitation program using this device against conventional face-to-face physical therapy. These studies have proven the feasibility, safety and effectiveness of this medical device on rehabilitation after total knee and hip arthroplasty.
SWORD Health is now seeking additional validation of its digital programs on acute and chronic MSK conditions, to assess the acceptance, engagement and outcomes of these clinical programs. This study will also unveil disease-specific human motion patterns that may be used to inform the development of new diagnostic and treatment tools.
Data to be collected on every individual undergoing our programs includes:
- data that is sourced from the subject through online assessment forms
- data that is sourced from the subject, collected by the physical therapist managing that subject (i.e. suggestions for improvement);
- data that is generated by the physical therapist through interaction with the web-based Portal (i.e. session composition in terms of exercises, sets, repetitions, usage or not of external resistance)
- data generated by the patient through interaction with the mobile app (i.e. pain and fatigue levels, satisfaction)
- data that is generated automatically by the medical device (i.e. range of motion, compliance)
Collection and objective analysis of the collected data will allow:
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old
- •Suffering from acute (<12 weeks) or chronic (>12 weeks) pain in the neck, low back, shoulder, elbow, hip, knee, ankle or wrist;
- •Able to understand study procedures and willing to provide informed consent
排除标准
- •Cardiac or respiratory condition incompatible with at least 20 minutes of light to moderate exercise
- •Cancer diagnosis or receiving treatment for cancer
- •Unexplained weight loss in the last 6 months
- •Significant trauma in the area of pain in the last 3 months
- •Rapidly progressive loss of strength and/or numbness in the arms/legs in the last 2 weeks
- •Unexplained change in bowel or urinary function in the last 2 weeks
- •Other known health condition limiting participation in an exercise program involving at least 20 minutes of light to moderate exercise
结局指标
主要结局
Neck Disability Index
时间窗: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Change in condition-specific clinical outcomes over time measured through the Neck Disability Index. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Oswestry Disability Index
时间窗: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Change in condition-specific clinical outcomes over time measured through the Oswestry Disability Index (ODI). \\ The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Short version of the Disabilities of the Arm, Shoulder and Hand questionnaire
时间窗: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Change in condition-specific clinical outcomes over time measured through the short version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH). Scoring Formula = (\[(sum of n responses)/n\] -1)x(25).
Hip Disability and Osteoarthritis Outcome Score
时间窗: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Change in condition-specific clinical outcomes over time measured through the hip disability and osteoarthritis outcome score (HOOS) Scoring Formula: 100 - \[(patient's score of the subscale x 100)/(total score of the subscale)\]
Neck, lower spine, shoulder, elbow, ankle, hip and knee range of motion
时间窗: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Change in condition-specific clinical outcomes over time measured through Neck, lower spine, shoulder, elbow, ankle, hip and knee range of motion (ROM) (flexion/extension/abduction/rotation), in degrees, as directly retrieved from the angle measurement tool integrated within the medical device.
Foot and Ankle Ability Measure
时间窗: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Change in condition-specific clinical outcomes over time, measured through the Foot and Ankle Ability Measure (FAAM). FAAM is a self-report measure that assesses physical function of individuals with lower leg, foot, and ankle musculoskeletal disorders. Thus instrument included 2 subscales: 1) Activities of Daily Living (ADLs) with 21 items and 2) Sports with 8 items. For each subscale patients are asked to answer each question with a single response that most clearly describes their condition within past week. To calculate the score for either subscale, the total number of points are added, divided by the total number os possible points (ADLs-84; Sports-32) and then multiplied by 100.
Knee Injury and Osteoarthritis Outcome Score
时间窗: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Change in condition-specific clinical outcomes over time measured through the Knee Injury and Osteoarthritis Outcome Score (KOOS) Scoring Formula: 100 - \[(patient's score of the subscale x 100)/(total score of the subscale)\]
次要结局
- Self-reported Medication(Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment)
- Self-reported Pain(Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment)
- Self-reported Surgical Intent(Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment)
- Depression(Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment)
- Engagement levels(Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment)
- Anxiety(Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment)
- Fear avoidance behaviour(Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment)
- Work Productivity and Absenteeism(Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment)
- Satisfaction scores(Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment)
- Completion rates(Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment)