Clinical trial NCT01485354: Upper Arm Training With Armeo Spring for Stroke
Official title: The Effect of Repetitive Upper Arm Training in a Virtual Environment on Upper Extremity Motor Recovery in Chronic-stroke Survivors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Rehabilitation
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2011-12-05
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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)
timeFrame: Data collected at baseline and at completion of the 3-week intervention
Secondary outcomes:
measure: 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)
timeFrame: Data collected at baseline and at completion of the 3-week intervention
measure: 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)
timeFrame: Data collected at baseline and at completion of the 3-week intervention
measure: 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)
timeFrame: Data collected at baseline and at completion of the 3-week intervention
measure: Change in Grip Strength (Strength Test) (i.e. Difference Between Grip Strength at Baseline and at Completion of the 3-week Intervention)
timeFrame: Data collected at baseline and at completion of the 3-week intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital Boston
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Paolo Bonato, PhD
role: PRINCIPAL_INVESTIGATOR
References: