Upper Arm Training With Armeo Spring for Stroke

Mass General Brigham

Status: Terminated

Conditions: Stroke

Treatments: Device: Armeo Spring training

Study type: Interventional

Funder types: Other

Identifiers

NCT01485354

2008-P-001255

Details and patient eligibility

About

The purpose of this study is to assess the clinical outcomes of upper extremity training using the Armeo Spring system in a chronic post-stroke population with impaired upper extremity function.

Full description

The Armeo Spring system is an adjustable arm orthosis that has received FDA 510K clearance. It passively counterbalances the weight of the arm, thereby reducing the effort required to overcome gravity during the performance of upper-limb movements. The device provides subjects with augmented feedback via a virtual environment (i.e. computer games). The tasks to be performed in the virtual environment are designed to achieve functional movements, such as arm reaching movements.

The goal of the study is to assess the clinical outcomes of upper extremity training using the Armeo Spring system in a chronic post-stroke population with impaired upper extremity function. The Armeo Spring system is equipped with a grip sensor that subjects squeeze with their hand to interact with virtual objects during the games. In a first phase of the study, we attempted to replace the grip sensor that is part of the system with a sensorized glove, to facilitate a more natural movement of hand opening/closing. However, we experienced technical difficulties with the sensorized glove and decided to abandon this aim for the purpose of gathering data about the clinical outcomes of upper extremity training using the Armeo Spring system.

Enrollment: 17 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female, community dwelling, age 18-70
• First-time non-traumatic ischemic or hemorrhagic stroke at least 3 months prior to study enrollment
• Score of 15-55 out of 66 on arm motor Fugl-Meyer scale
• The ability to extend >=10 degrees at metacarpophalangeal and interphalangeal joint of all digits

Exclusion criteria

• Cognitive impairment that may interfere with understanding instructions for motor tasks and assessment tools
• Inability to operate the Armeo system (subjects must have sufficient range of movement to enable calibration of the virtual workspace)
• Participation in other forms of therapy/intervention for upper extremity motor recovery

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Armeo Spring training

Experimental group

Description:

Subjects will participate in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention will consist of 18 training sessions (60 minute sessions, 3 times a week).

Treatment:

Device: Armeo Spring training