NCT01485354

Upper Arm Training With Armeo Spring for Stroke

The Effect of Repetitive Upper Arm Training in a Virtual Environment on Upper Extremity Motor Recovery in Chronic-stroke Survivors

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Spaulding Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Armeo Spring training	Upper-limb training using the Armeo system for a period of 6 weeks

Timeline

• Start date: 2008-12-01
• Primary completion: 2015-10-01
• Completion: 2017-03-01
• First posted: 2011-12-05
• Last updated: 2017-07-12
• Results posted: 2017-07-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study