Upper Arm Training With Armeo Spring for Stroke

NCT ID: NCT01485354

Last Updated: 2017-07-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2017-03-31

Brief Summary

The purpose of this study is to assess the clinical outcomes of upper extremity training using the Armeo Spring system in a chronic post-stroke population with impaired upper extremity function.

Detailed Description

The Armeo Spring system is an adjustable arm orthosis that has received FDA 510K clearance. It passively counterbalances the weight of the arm, thereby reducing the effort required to overcome gravity during the performance of upper-limb movements. The device provides subjects with augmented feedback via a virtual environment (i.e. computer games). The tasks to be performed in the virtual environment are designed to achieve functional movements, such as arm reaching movements.

The goal of the study is to assess the clinical outcomes of upper extremity training using the Armeo Spring system in a chronic post-stroke population with impaired upper extremity function. The Armeo Spring system is equipped with a grip sensor that subjects squeeze with their hand to interact with virtual objects during the games. In a first phase of the study, we attempted to replace the grip sensor that is part of the system with a sensorized glove, to facilitate a more natural movement of hand opening/closing. However, we experienced technical difficulties with the sensorized glove and decided to abandon this aim for the purpose of gathering data about the clinical outcomes of upper extremity training using the Armeo Spring system.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Armeo Spring training

Subjects will participate in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention will consist of 18 training sessions (60 minute sessions, 3 times a week).

Group Type: EXPERIMENTAL

Armeo Spring training

Intervention Type: DEVICE

Upper-limb training using the Armeo system for a period of 6 weeks

Interventions

Armeo Spring training

Upper-limb training using the Armeo system for a period of 6 weeks

Intervention Type: DEVICE

Other Intervention Names

Armeo Spring (Hocoma AG, Switzerland)

Eligibility 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 the Armeo system (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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Paolo Bonato

Director, Motion Analysis Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paolo Bonato, PhD

Role: PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital

Locations

Spaulding Rehabilitation Hospital Boston

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2008-P-001255

Identifier Type: -

Identifier Source: org_study_id