Harmony Scapulohumeral Rhythm (SHR) Reliability and Efficacy Study

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.

Inclusion criteria

• 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

Exclusion criteria

• Pregnant
• 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.