Upper Arm Training With Armeo Spring for Stroke (Armeo Stroke)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Paolo Bonato, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01485354
First received: June 28, 2011
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.

Condition Intervention Phase
Stroke
Device: Sensing glove
Device: Grip Sensor
Phase 0

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: December 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sensing Glove Device: Sensing glove
Comparing the use of Armeo with grip sensor to use of Armeo with sensing glove
Other Names:
  • Device: Sensing Glove
  • Produced by: Interdepartmental Centre "E.Piaggio", University of Pisa, Italy and Smartex SRL
Placebo Comparator: Grip Sensor Device: Grip Sensor
Typical use of Armeo Spring without the use of Sensing Glove.
Other Names:
  • Device: Armeo Spring
  • Produced by: Hocoma

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485354

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital Boston
Boston, Massachusetts, United States, 02129
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Paolo Bonato, PhD Spaulding Rehabilitation Hospital
  More Information

No publications provided

Responsible Party: Paolo Bonato, Director, Motion Analysis Laboratory, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01485354     History of Changes
Other Study ID Numbers: 2008-P-001255
Study First Received: June 28, 2011
Last Updated: March 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Spaulding Rehabilitation Hospital:
stroke
Armeo

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 26, 2014