Upper Arm Training With Armeo Spring for Stroke



Status:Active, not recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:December 2008
End Date:December 2016

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

The purpose of this study is:

1. To demonstrate that upper extremity training with the Armeo system with a sensing glove
will result in greater functional improvement as measured by clinical functional
outcome measures, than Armeo training with grip sensor, in a chronic post-stroke
population with impaired upper extremity function.

2. To compare kinematic data following training with grip sensor vs. sensing glove, using
data provided by the Armeo system, clinical outcome measures and data derived from the
analysis of upper extremity movements using a camera-based motion analysis system.

By using the Armeo system, the investigators hope to achieve repetitive training of reach,
grasp, and release in an engaging environment that can be adapted to individual
capabilities, and to enable stroke survivors whose motor weakness may have excluded them
from performing repetitive therapy tasks, to participate in this study.The Armeo system is
an adjustable arm orthosis that has received FDA 510k exemption. It passively
counterbalances the weight of the arm, thereby reducing the effort required by the paretic
arm to overcome gravity. The device is able to augment feedback through a virtual
environment (i.e. computer games). The tasks presented in the virtual environment are
designed to achieve functional movements, i.e. the subject has to perform tasks such as
reaching for objects as part of the game.

The ability to reach and grasp is a necessary component of many daily-life functional tasks.
Impaired reach and grasp following strokes result in the recruitment of compensatory
measures such as increased use of the trunk to transport the hand.

As an end-effector, the grip sensor provides a point of attachment, compared to the glove,
in which the hand is free. The posture of the hand, range of movement, joint adaptations,
movement pattern and kinematics are likely to be affected by a free or fixed end-effector.
In this study, the investigators would like to compare the efficacy of training with both
end-effectors. The investigators will also compare efficacy of these 2 end-effectors in
high-functioning vs low-functioning hemiparetic subjects.

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 Armeo system (which will be assessed during the calibration
process. 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
We found this trial at
1
site
Boston, Massachusetts 02114
?
mi
from
Boston, MA
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