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Harmony Scapulohumeral Rhythm (SHR) Reliability and Efficacy Study

Safety, Reliability, and Efficacy of the Harmony SHR Upper Extremity Robotic Rehabilitation System in the Inpatient Rehabilitation Setting for Patients With Acute Stroke

NCT05251077•Shirley Ryan AbilityLab

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

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:
+8 more criteria

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
+3 more criteria

Locations (1)

Shirley Ryan AbilityLab

Chicago, Illinois, United States

Key Dates

Start Date

January 1, 2022

Primary Completion Date

May 30, 2023

Completion Date

May 30, 2023

Last Updated

February 24, 2026

Enrollment

ACTUAL participants

Conditions

Stroke, Acute

Interventions

Harmony SHR

DEVICE

Traditional Occupational Therapy

OTHER

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Harmony Scapulohumeral Rhythm (SHR) Reliability and Efficacy Study

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke

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Validation of Early Prognostic Data for Recovery Outcome After Stroke for Future, Higher Yield Trials

Long-Term Outcomes of LAA Contrast Flow in CT Scans After Endocardial LAA Closure: The CF-CT Registry

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Effects of Minocycline on Patients With Ischemic Stroke Undergoing Intravenous Thrombectomy