The Effect of Repetitive Upper Arm Training in a Virtual Environment on Upper Extremity Motor Recovery in Chronic-stroke Survivors
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Spaulding Rehabilitation Hospital
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- 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)
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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.
Investigators
Paolo Bonato
Director, Motion Analysis Laboratory
Spaulding Rehabilitation Hospital
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
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)
Time Frame: Data collected 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.
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)(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)(Data collected at baseline and at completion of the 3-week intervention)
- Change in Box and Block Test Score (Manual Dexterity Test) (i.e. Difference Between Box and Block Test Score at Baseline and at Completion of the 3-week Intervention)(Data collected at baseline and at completion of the 3-week intervention)
- Change in Grip Strength (Strength Test) (i.e. Difference Between Grip Strength at Baseline and at Completion of the 3-week Intervention)(Data collected at baseline and at completion of the 3-week intervention)