Upper Arm Training With Armeo Spring for Stroke (Armeo Stroke)
The purpose of this study is:
- 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.
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||The Effect of Repetitive Upper Arm Training in a Virtual Environment on Upper Extremity Motor Recovery in Chronic-stroke Survivors|
- Change in Grip Strength from Baseline [ Time Frame: Baseline, 10 weeks ] [ Designated as safety issue: No ]
- Change in Box and Block Test score from Baseline [ Time Frame: Baseline, 10 weeks ] [ Designated as safety issue: No ]
- Change in Graded Wolf Motor Function Test score from Baseline [ Time Frame: Baseline, 10 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: Sensing Glove||
Device: Sensing glove
Comparing the use of Armeo with grip sensor to use of Armeo with sensing glove
|Placebo Comparator: Grip Sensor||
Device: Grip Sensor
Typical use of Armeo Spring without the use of Sensing Glove.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485354
|United States, Massachusetts|
|Spaulding Rehabilitation Hospital Boston|
|Boston, Massachusetts, United States, 02129|
|Principal Investigator:||Paolo Bonato, PhD||Spaulding Rehabilitation Hospital|