Upper Arm Training With Armeo Spring for Stroke "Armeo Stroke"

Active, not recruiting

Phase 0 Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • Sensing glove (Interdepartmental Centre "E.Piaggio", University of Pisa, Italy) Device
    Intervention Desc: Comparing the use of Armeo with grip sensor to use of Armeo with sensing glove
    ARM 1: Kind: Experimental
    Label: Sensing Glove
  • Grip Sensor (Hocoma Armeo Spring) Device
    Intervention Desc: Typical use of Armeo Spring without the use of Sensing Glove.
    ARM 1: Kind: Experimental
    Label: Grip Sensor
  • Sensing glove Device
    Other Names: Device: Sensing Glove; Produced by: Interdepartmental Centre "E.Piaggio", University of Pisa, Italy and Smartex SRL
    Intervention Desc: Comparing the use of Armeo with grip sensor to use of Armeo with sensing glove
    ARM 1: Kind: Experimental
    Label: Sensing Glove
  • Grip Sensor Device
    Other Names: Device: Armeo Spring; Produced by: Hocoma
    Intervention Desc: Typical use of Armeo Spring without the use of Sensing Glove.
    ARM 1: Kind: Experimental
    Label: Grip Sensor

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Grip Strength 10 weeks No
Primary Box and Block Test 10 weeks No
Primary Graded Wolf Motor Function Test 10 weeks No
Primary Change in Grip Strength from Baseline Baseline, 10 weeks No
Primary Change in Box and Block Test score from Baseline Baseline, 10 weeks No
Primary Change in Graded Wolf Motor Function Test score from Baseline Baseline, 10 weeks No

Sponsors