Safety, Reliability, and Efficacy of the Harmony SHR Upper Extremity Robotic Rehabilitation System in the Inpatient Rehabilitation Setting for Patients With Acute Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Upper Extremity Fugl-Meyer Assessment (UE FMA)
研究概览
简要总结
The purpose of this study is to assess the safety, reliability, and efficacy of the use of the Harmony Scapulohumeral Rhythm (SHR) upper extremity robotic rehabilitation system for persons with impaired functional use of one or both upper extremities due to stroke.
详细描述
Once recruited, subjects will be randomly assigned to traditional or intervention groups. Subjects in the traditional therapy group will receive up to 24 sessions of traditional occupational therapy intervention focusing on upper limb task training. Subjects in the intervention group will receive up to 24 sessions of functional task training using the Harmony SHR device. These sessions will be conducted by a trained researcher or licensed occupational therapist. Outcome measures will be assessed prior to the first intervention session and following the last intervention session, prior to discharge from inpatient rehabilitation.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Limited or impaired functional use of one or both upper extremities due to stroke
- •Currently admitted to the Shirley Ryan AbilityLab as an inpatient
- •Minimum passive Range of Motion requirements as follows:
- •Shoulder flexion: 90⁰ minimum with zero starting point of arm perpendicular to the floor and 90⁰ measuring at a right angle parallel to the floor in the sagittal plane
- •Shoulder abduction: 90⁰ minimum with zero starting point of arm perpendicular to the floor and 90⁰ measuring at a right angle parallel to the floor in the coronal/frontal plane
- •Shoulder rotation: tolerating of don/doff position, depending on the degree of ER required for that position
- •Elbow flexion: 90⁰ minimum with zero starting point of arm perpendicular to the floor and 90⁰ measuring at a right angle parallel to the floor in the sagittal plane
- •Wrist pronation: 0⁰ minimum with the zero starting point of the forearm in neutral with the palm of the hand pointing inward and the thumb pointing up, perpendicular to the floor
- •Have skeletal measurements within the ranges specified:
- •Seated shoulder height in range of 840 mm to 1122 mm measured as the sum of the following:
- •Seat of chair to acromion process of seated patient
- •Height of the chair
- •Shoulder Breadth in the range of 324mm to 443mm measured between the acromion process in one scapula to the acromion process on the other scapula
- •Humeral length in the range of 250mm to 350mm measured between the greater tubercle to lateral epicondyle
- •Ulnar length in the range of 228 mm to 306 mm measured between the olecranon to head of ulna/styloid process
- •21 years of age or older
- •Ability to safely transfer from mobility device to standard chair with no armrests or with the assistance of a licensed occupational therapist/trained research staff
- •Able and willing to give written consent and comply with study procedures
排除标准
- •Pressure injury or exposed broken skin at sites of contact with device
- •History of mastectomy and/or axillary lymph node resection or history of active lymphedema in upper extremity
- •Recent sternotomy/active sternal precautions
- •Recent pacemaker/ICD placement with active pacemaker precautions
- •Inability to tolerate upright position and traditional therapy outside of the device
- •Spasticity >3 on the Modified Ashworth Scale (MAS)
- •Medical line (e.g., IV, PICC, dialysis port) at contact points
- •Heterotrophic ossification
- •Unresolved deep vein thrombosis
- •Fixed joint contractures that limit movement required to use device
- •Inability to express pain/discomfort
- •Presence of a condition that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
研究组 & 干预措施
Intervention
Participants in this group will receive functional task training with use of the Harmony SHR device up to 24 sessions, 60 minutes in length, during the participant's inpatient rehabilitation stay.
干预措施: Harmony SHR (Device)
Optimization group
Up to 10 participants will be enrolled to identify optimal device application in the acute stroke population. These participants will not be randomized into the intervention group or control group. They will receive the same treatment as the intervention group. The purpose of this group is to 1) train study staff prior to randomization and 2) ensure that the inclusion/exclusion criteria is adequate.
干预措施: Harmony SHR (Device)
Active control
Participants in this group will receive traditional occupational therapy up to 24 sessions, 60 minutes in length, during the participant's inpatient rehabilitation stay.
干预措施: Traditional Occupational Therapy (Other)
结局指标
主要结局
Upper Extremity Fugl-Meyer Assessment (UE FMA)
时间窗: Prior to intervention start, day 1, and prior to discharge from inpatient rehabilitation (on average day 21) and the change in score will be recorded.
The Upper Extremity Fugl-Meyer Assessment (UE FMA) is a 33 item stroke-specific, performance-based impairment index designed to assess motor functioning, balance, sensation, and joint functioning in patients with post-stroke hemiplegia. For the purposes of this study, only the upper extremity motor functioning domain will be assessed. This domain is comprised of assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. Scoring is based on direct observation of performance and items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0 = cannot perform, 1 = performs partially, and 2 = performs fully. Total score range is from 0 to 66, with a higher total score indicates less impairment of the UE being tested.
次要结局
- Action Research Arm Test (ARAT)(Prior to intervention start, day 1, and prior to discharge from inpatient rehabilitation (on average day 21) and the change in score will be recorded)
研究者
Arun Jayaraman, PT, PhD
Director, Max Nader Center for Rehabilitation Technologies & Outcomes Research
Shirley Ryan AbilityLab