Upper Arm Training With Armeo Spring for Stroke

Spaulding Rehabilitation Hospital17 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke

Interventions

Armeo Spring trainingDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Spaulding Rehabilitation Hospital Boston

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Change in Upper-extremity Fugl-Meyer Score (Measure of Motor Impairment) (i.e. Difference Between Fugl-Meyer Score at Baseline and at Completion of the 3-week Intervention)

The upper-extremity Fugl-Meyer scale allow one to assess the severity of motor impairments in stroke survivors using a scale from 0 (severe impairment) to 66 (no impairment). It is based on visual observations gathered by asking subjects to perform upper-limb movements using the stroke-affected limb. Therapists rate the performance of the motor tasks using an ordinal scale ranging from 0 (cannot perform) to 2 (can perform fully) that captures the motor ability of the individual. The investigators computed the difference between the Fugl-Meyer score at completion of the 3-week intervention and the Fugl-Meyer score at baseline.

Time frame: Data collected at baseline and at completion of the 3-week intervention

Secondary Outcomes

Change in Wolf Motor Function Test Score (a Functional Test) (i.e. Difference Between Wolf Motor Function Test Score at Baseline and at Completion of the 3-week Intervention)

The Wolf Motor Function test is designed to assess the severity of functional limitations in stroke survivors. The scale is administered by asking subjects to perform a series of functional movements (e.g. reach for and pick up a paperclip). The outcome of the assessment is the average time needed to perform the motor tasks that are part of the assessment. The score ranges from 0 to 120 s (i.e. if the subject is unable to perform the task, the score for that task is set to 120 s). The investigators computed the difference between the Wolf Motor Function Test score at completion of the 3-week intervention and the Wolf Motor Function Test score at baseline.

Time frame: Data collected at baseline and at completion of the 3-week intervention

Change in Functional Ability Scale Score (Scale to Rate Quality of Movement) (i.e. Difference Between Functional Ability Scale Score at Baseline and at Completion of the 3-week Intervention)

The Functional Ability Scale is designed to assess the quality of movement during the performance of a battery of functional tasks. Therapists observe the subject while performing the motor tasks and use an ordinal scale to rate the quality of movement. The scale used to rate each motor task ranges from 0 to 5. The Functional Ability Scale is derived by adding up the scores for each motor task performed by the subject. Subjects perform 15 motor tasks. Hence the Functional Ability Scale score varies from 0 (very poor quality of movement) to 75 (physiological movement). The investigators computed the difference between the Functional Ability Scale score at completion of the 3-week intervention and the Functional Ability Scale score at baseline.

Data from ClinicalTrials.gov

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