Harmony Scapulohumeral Rhythm (SHR) Reliability and Efficacy Study

NCT05251077 | Completed Results FDA Device

• 1 other identifier: NWSTU00215864
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

Optimization group

OTHER

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

Active control

ACTIVE COMPARATOR

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

Intervention

EXPERIMENTAL

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

Interventions

Harmony SHR DEVICE

Functional task training with use of Harmony SHR device

Intervention; Optimization group

Traditional Occupational Therapy OTHER

Functional task training of affected limb

Active control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Harmonic Bionics: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60661, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Arun Jayaraman
• Organization: Shirley Ryan AbilityLab

ajayaraman@sralab.org

312-238-1000

Study Officials

• Arun Jayaraman, PT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Max Nader Center for Rehabilitation Technologies & Outcomes Research

Model Details: One group will receive traditional occupational therapy while the other group will receive occupational therapy with use of the Harmony SHR device.

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 22, 2022
• Study Start: January 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: February 24, 2026
• Results First Posted: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)