Robot arm helps stroke survivors move again
NCT ID NCT05251077
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a robotic system called Harmony SHR to help people who had a stroke and have trouble moving one or both arms. The robot assists with shoulder and arm movements during rehab. The goal was to see if it is safe, reliable, and helpful for improving arm function. The study included 21 patients in a rehab hospital.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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21 people
The number who actually took part.
- Started
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Jan 2022
- Finished
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May 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Shirley Ryan AbilityLab
Chicago, Illinois, 60661, United States
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Other studies related to the condition(s) this trial covers.
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