Harmony Scapulohumeral Rhythm (SHR) Reliability and Efficacy Study

February 19, 2026 updated by: Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Upper Extremity Fugl-Meyer Assessment (UE FMA)
Time Frame: 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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Action Research Arm Test (ARAT)
Time Frame: 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 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shirley Ryan AbilityLab

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Harmonic Bionics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Arun Jayaraman, PT, PhD, Shirley Ryan Abilitylab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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