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

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Acute
• Intervention / Treatment: Device: Harmony SHR; Other: Traditional Occupational Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60661
      • Shirley Ryan Abilitylab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: Harmony SHR; Functional task training with use of Harmony SHR device
Active Comparator: 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.	Other: Traditional Occupational Therapy; Functional task training of affected limb
Experimental: 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.	Device: Harmony SHR; Functional task training with use of Harmony SHR device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper Extremity Fugl-Meyer Assessment (UE FMA)	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Action Research Arm Test (ARAT)	The Action Research Arm Test (ARAT) is a 19 item observational measure used to assess upper extremity performance (coordination, dexterity, and functioning) in stroke recovery, brain injury, and multiple sclerosis. Items comprising the ARAT are categorized into 4 subscales (grasp, grip, pinch, gross motor) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Score ranges from 0-57. Higher total score indicates more function of the UE being tested.	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

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab
• Collaborators: Harmonic Bionics
• Investigators: Principal Investigator: Arun Jayaraman, PT, PhD, Shirley Ryan Abilitylab

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: NWSTU00215864

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No