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Upper Arm Training With Armeo Spring for Stroke

This study has been terminated.
(Lack of funding)
Sponsor:
Information provided by (Responsible Party):
Paolo Bonato, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01485354
First received: June 28, 2011
Last updated: June 12, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention
Stroke Device: Armeo Spring training

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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 Paolo Bonato, Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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) [ Time Frame: Data collected 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.

  • 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) [ Time Frame: Data collected 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.

  • 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) [ Time Frame: Data collected at baseline and at completion of the 3-week intervention ]
    The Box and Block test is designed to assess manual dexterity in subjects with motor impairments. Subjects are asked to move small wooden blocks from one box to another, moving their stroke-affected arm over a divider between the two boxes. The output of the test is the number of blocks that the subject moves from one box to the other within a set amount of time (i.e. 1 min). Older adults who are otherwise healthy would typically move 60 to 70 blocks in 1 min. Hence, the range of the scale for older adults is 0 to 70. The investigators computed the difference between the Box and Block Test score at completion of the 3-week intervention and the Box and Block Test score at baseline.

  • Change in Grip Strength (Strength Test) (i.e. Difference Between Grip Strength at Baseline and at Completion of the 3-week Intervention) [ Time Frame: Data collected at baseline and at completion of the 3-week intervention ]
    This test is carried out by using a hand dynamometer that measures the grip strength of the individual in kilograms (used as a measure of force). Subjects are instructed to position the thumb on one handle of the dynamometer and the other fingers on the other handle of the dynamometer. The device measures the force generated by the subject using a power grip. The investigators computed the difference between the Grip Strength value at completion of the 3-week intervention and the Grip Strength value at baseline.


Enrollment: 17
Actual Study Start Date: December 2008
Study Completion Date: March 2017
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
Device: Armeo Spring training
Upper-limb training using the Armeo system for a period of 6 weeks
Other Name: Armeo Spring (Hocoma AG, Switzerland)

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

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
  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

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
Results First Received: April 5, 2017
Last Updated: June 12, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Paolo Bonato, Spaulding Rehabilitation Hospital:
Stroke
Rehabilitation

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

ClinicalTrials.gov processed this record on July 27, 2017