Upper Arm Training With Armeo Spring for Stroke

Stroke Clinical Trial

— Armeo Stroke  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01485354
• Other study ID #: 2008-P-001255
• Status: Active, not recruiting
• Phase: Phase 0
• First received: June 28, 2011
• Last updated: April 7, 2016
• Start date: December 2008
• Est. completion date: December 2016

Study information

• Verified date: April 2016
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17
• Est. completion date: December 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Sensing glove
Comparing the use of Armeo with grip sensor to use of Armeo with sensing glove
• Grip Sensor
Typical use of Armeo Spring without the use of Sensing Glove.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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