Teletherapy for Upper Extremity Fracture Rehabilitation, A Pilot Randomized Controlled Trial (TELE-REHAB Study)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Feasibility outcome 2b: Completion rate
研究概览
简要总结
Following upper limb surgeries, patients could receive occupational therapy either in-person or remotely (teletherapy). The investigators currently do not know which occupational therapy delivery is better in terms of clinical outcomes and patient recovery. The proposed study is a pilot randomized controlled trial (RCT) testing the feasibility of comparing in-person occupational therapy to teletherapy following operative fixation of upper extremity fracture. It is a single site, parallel-arm, randomized controlled trial to compare teletherapy versus in-person occupational therapy. Patients who are eligible will be randomized similar to a flip of a coin (1:1) to occupational therapy in-person or through a telemedicine platform. Patients would also complete surveys at each follow-up visit to measure 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
- Other
- 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
- •Participants must have had operative fixation of upper extremity fracture located between the humeral shaft and distal radius (inclusive) who are indicated for outpatient occupational therapy.
- •Participants at least 18 years (≥ 18 years of age).
- •English-speaking participants
排除标准
- •Participants unable to consent
- •Vulnerable populations including prisoners and marginally housed patients
- •Additional traumatic conditions that may affect the ultimate-use pattern of the injured limb including traumatic brain injury, spinal cord injury, peripheral nerve injury, or associated soft tissue injury requiring specific postoperative activity modifications.
- •Contralateral upper extremity injury that prevents participating in the standardized exercises.
- •Initiation of occupational therapy (OT) during an inpatient hospital stay
- •Pre-existing comorbidities that may interfere with communication or that may limit the use of standard telecommunications tools (sight/hearing impaired, speech impaired)
- •Patients without a smart-phone or internet access.
结局指标
主要结局
Feasibility outcome 2b: Completion rate
时间窗: at 3 months
A success threshold of 90% patient follow-up and case report forms
Feasibility outcome 2c: Completion rate
时间窗: at 6 months
A success threshold of 90% patient follow-up and case report forms
Feasibility outcome 1: Enrollment rate
时间窗: At 12 months
A success threshold of 40% enrollment of eligible patients
Feasibility outcome 2a: Completion rate
时间窗: at 6 weeks
A success threshold of 90% patient follow-up and case report forms completion rates
次要结局
未报告次要终点
研究者
Christopher Langhammer
Assistant Professor
University of Maryland, Baltimore