Wellclub Shoulder Therapy Outcome Validation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Change in performance measured by percentages
研究概览
简要总结
Preliminary evaluations have been completed and resulted in patients and therapist indicating positive outcomes through increased patient engagement, asynchronous communications (i.e. messaging) between therapists and patients, and objective assessment and monitoring of exercises performed by the patients. The investigator's hypothesis is that patients using the Wellclub device and application in addition to in-clinic physical therapy will be more compliant with their home exercise programs and have the same or better functional outcomes than patients with similar conditions who use in-clinic care only.
详细描述
Patients seeking an initial outpatient physical therapy evaluation for non-surgical shoulder impingement with pain, who own iPhones with iOS 8 or later. Patients will be randomized into the study group or the control group, and be seen at least once per week by their physical therapist for the duration of the therapy episode, or up to 12 weeks. The study group will be asked to strap to their wrist a small, measurement device and download a smartphone application. The App communicates with the wearable device and reminds them to complete their therapy and provides patients visual instruction, feedback on exercise quality, and exercise count for the prescribed physical therapy. The control group will only have traditional in-clinic therapy as deemed clinically necessary by the PT.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Shoulder impingement not requiring immediate surgery
排除标准
- •Rotator cuff tear (RCT)
- •Surgical history of rotator cuff repair (RCR)
- •Cortisone injection or other injectable for past 6 months
- •Prescription NSAIDs in the past 6 months
- •Frozen shoulder syndrome
- •Neurological conditions
- •Other orthopaedic conditions (spine/neck)
结局指标
主要结局
Change in performance measured by percentages
时间窗: Baseline and 6 weeks
Percentage of completed exercises correctly completed by the patient
Change in score on SPADI (Shoulder Pain And Disability Index)
时间窗: Baseline and 6 weeks
SPADI is a scale consisting of 0-10 0 being the best and 10 being the worse pain ever
Change in degrees of shoulder range of motion
时间窗: Baseline and 6 weeks
Change in range of motion on metered scale
次要结局
未报告次要终点