Digitally Assisted Rehabilitation Programs for Musculoskeletal Disorders: a Large-scale, Multi-disorder, Prospective, Longitudinal Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10,500
- 试验地点
- 1
- 主要终点
- Foot and Ankle Ability Measure (FAAM)
研究概览
简要总结
The purpose of this study is to create a research repository, comprised of data collected in the course of physical rehabilitation programs for musculoskeletal disorders (MSDs) using the medical device SWORD Phoenix®.
This will allow the company to ascertain the acceptance, engagement and effectiveness of programs using this asynchronous tele-rehabilitation platform in the treatment of multiple MSDs.
详细描述
The data that will be collected in the scope of this registry includes:
- data that is sourced from the subject, which will be collected by the physical therapist managing that subject;
- 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 that is generated by the subject through interaction with the 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:
- Assess the adoption, engagement and feasibility of digital care programs for musculoskeletal conditions and musculoskeletal health
- Assess the results of digital care programs and compare the costs with the benefits obtained;
- Correlate the results with patient's demographic and clinical profiles;
- Examine the impact of mental health and the behavioral modification components of SWORD Health interventions on disease markers, comorbidities, and productivity;
- Increase the knowledge on several musculoskeletal conditions, namely how they progress and respond to digital care programs;
- Develop new or improved tools to assist clinicians in the management of these conditions and in helping people achieve better musculoskeletal health
Clinical outcomes
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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;
- •Initiating a rehabilitation program using the medical device SWORD Phoenix®;
- •Able to understand study procedures and willing to provide informed consent.
排除标准
- 未提供
结局指标
主要结局
Foot and Ankle Ability Measure (FAAM)
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 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 meniscal repair or cruciate ligament reconstruction patients' clinical outcomes over time measured through knee range of motion (ROM) (flexion/extension/abduction/rotation), in degrees, as directly retrieved from the angle measurement tool integrated within the medical device.
Constant-Murley Shoulder Outcome Score (CM)
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 CM score. The scale consists of: 1. Subjective variables: a) Pain - Absence of pain gets maximum score of 15; b) Limitation of Activities of daily living (sleep, work, recreation/sport). No limitations get maximum score, 20. The subjective variables add to a maximum score of 35. 2. Objective variables: c) Range of motion - Maximum score 40; d) Strength - Maximum Score 25 Objective variables add to a total of 65. Total Constant Score is calculated by adding the scores from subjective and objective variables. The maximum possible total score is 100.
Oswestry Disability Index (ODI)
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.
Timed-up-and-go test (TUG)
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 TUG test. The TUG consists on the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. As a reference, patients treated with conventional physiotherapy 6 months after total knee replacement reported a TUG of 9.1 seconds.
次要结局
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment)
- Hip Disability and Osteoarthritis Outcome Score(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 (NPRS)(Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment)
- Self-reported satisfaction(Each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment)
- Compliance(Each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment)
- Neck, lower spine, shoulder, elbow, ankle, hip and knee range of motion (ROM)(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)
- Short version of the Disabilities of the Arm, Shoulder and Hand questionnaire(Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment)
- Self-reported fatigue (VAS)(Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment)
- Single leg stance test (SLS)(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 (VAS)(Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment)