Motor Rehabilitation of the Shoulder Complex After Orthopaedic Injury or Surgery Because of Work Accidents: a Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Number of adverse events
研究概览
简要总结
The purpose of this pilot study is to validate the safety, reliability and usability of FLOAT medical device, a prototypal robotic system for the rehabilitation of the shoulder, designed and developed in the Rehab Technologies IIT-INAIL Lab to fulfil the needs orthopaedic conditions. The acceptance from patients and therapists will be assessed after a single session of robotic therapy in a sample of injured workers suffering from post-traumatic or post-surgical shoulder disorders.
详细描述
This study aims to:
- Test the safety and reliability of the FLOAT device for delivering post-acute motor and functional rehabilitation of patients with orthopaedic shoulder dysfunction.
- Assess the three different modalities of utilization of the exoskeleton (Passive Mode, Learn&Repeat Mode, Transparency Mode).
- Evaluate the usability of the device in terms of comfort, adaptability to different patients' anthropometrics, general functioning and overall satisfaction.
Six injured workers with shoulder post-traumatic and post-operative dysfunction will be enrolled in a single testing session at the INAIL Rehabilitation Center in Volterra. Pilot testing of FLOAT device will focus mainly on the feasibility of implementing the multiple operating modes of the new device, recording patients and therapist's feedback. The session will last about 3 hours and all exercises will be administered by a trained physical therapist supported by a member of the engineering team.
For Aim 1, Safety and Reliability of the device will be evaluated in terms of the number of adverse events and malfunctions occurring during the study session.
For Aim 2, each modality will be assessed by means of the Numeric Pain Rating Scale (NPRS), The Borg CR10 Scale Perceived Exertion (only for the Transparent mode) and ad-hoc clinician-generated questionnaires for both patients and therapists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 否
入选标准
- •Height between 160 and 185 cm;
- •Distance between the shoulder joint center and the sagittal plane between 156 and 197 mm;
- •Shoulder joint center to wall distance between 82 and 142 mm
- •Maximum shoulter radius: 120 mm
- •Distance between the shoulder joint center and the elbow joint center between 250 and 303 mm
- •Time from acute event ≥ 60 days
- •Right shoulder joint disfunction after orthopaedic injury or surgery as a result of work accidents
- •Post-immobilization phase
- •At least 80° shoulder passive flexion and 45° shoulder passive abduction
- •Pain intensity on movement < 6 NRS;
排除标准
- •Glenohumeral joint instability
- •Shoulder Prosthetic implants
- •Upper arm sensorimotor deficits
- •Chronic inflammatory disorder involving upper arm joints
- •Pseudoarthrosis of the proximal humerus fractures
- •Spinal fractures within the last 3 months
- •Open skin at the level of the patient-device interface
- •Current or prior history of malignancy
- •Pregnancy or breast feeding
结局指标
主要结局
Number of adverse events
时间窗: 1 year
The physiotherapist is required to report any adverse events occurring during the study in regard to the use of FLOAT, for the purpose of evaluating the safety of the device
Number of device malfunctions
时间窗: 1 year
The physiotherapist is required to report any malfunctions occurring during the study in regard to the use of FLOAT, for the purpose of evaluating the reliability of the device
次要结局
- Numeric Pain Rating Scale (NPRS)(1 year)
- The Borg Category-Ratio Scale (CR-10)(1 year)
- Ad-hoc questionnaires for the patient, one for each of the three modalities (for a total amount of 3 questionnaires)(After the completion of the testing session with each of the three modalities)
- Ad-hoc questionnaires for the therapist, one for each of the three modalities (for a total amount of 3 questionnaires)(1 year)
- Ad-hoc questionnaire for the patient (final evaluation)(1 year (at the end of the study))
- Ad-hoc questionnaire for the therapist (final evaluation)(1 year (at the end of the study))