Motor Learning in a Customized Body-Machine Interface (BMI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Rehabilitation Institute of Chicago
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ferdinando Mussa-Ivaldi, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier:
NCT01608438
First received: April 16, 2012
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

People with tetraplegia often retain some level of mobility of the upper body. The proposed study will test the hypothesis that it is possible to develop personalized interfaces, which utilize the residual mobility to enable paralyzed persons to control computers, wheelchairs and other assistive devices. If successful the project will result into the establishment of a new family of human-machine interfaces based on wearable sensors that adapt their functions to their users' abilities.


Condition Intervention Phase
Spinal Cord Injury
Device: Customizing the Body-Machine Interface
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Motor Learning in a Customized Body-Machine Interface for Persons With Paralysis

Resource links provided by NLM:


Further study details as provided by Rehabilitation Institute of Chicago:

Primary Outcome Measures:
  • Change in Time to task completion from Baseline at 8 months [ Time Frame: Baseline and 8 months ] [ Designated as safety issue: No ]
    The subjects will perform computer games requiring different data entry tasks (characters, cursor control) and navigate either a virtual or a real obstacle course. This primary outcome measure is the time it takes subjects to complete each task.


Secondary Outcome Measures:
  • Change in Movement Smoothness from Baseline at 8 months [ Time Frame: Baseline and 8 months ] [ Designated as safety issue: No ]
    This outcome measure measures the change in movement smoothness when operating the virtual and real wheelchairs

  • Change in Strength [ Time Frame: Baseline and 8 months ] [ Designated as safety issue: No ]
    This outcome measure measures the changes in upper body strength after training

  • Change in Mental State [ Time Frame: Baseline and 8 months ] [ Designated as safety issue: No ]
    This outcome measures measures the change in mental state (as quantified by the State-Trait Anxiety Inventory) after training


Estimated Enrollment: 46
Study Start Date: February 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SCI Static
SCI group that practices with a static body-machine map
Device: Customizing the Body-Machine Interface
The intervention compares two ways of customizing the body-machine interface which will be used for subjects for 40 sessions (spread over 8 months). In one case (SCI static), the body-machine interface is static. In the other case (SCI Machine Learning), there is a machine learning algorithm that adapts to the movements made by the subject.
Experimental: SCI Machine Learning
Spinal Cord Injury patients who practice with a body-machine map that is adapted using machine learning
Device: Customizing the Body-Machine Interface
The intervention compares two ways of customizing the body-machine interface which will be used for subjects for 40 sessions (spread over 8 months). In one case (SCI static), the body-machine interface is static. In the other case (SCI Machine Learning), there is a machine learning algorithm that adapts to the movements made by the subject.

Detailed Description:

The goal of these studies is to enable persons paralyzed by spinal cord injury (SCI) to drive powered wheelchairs and interact with computers by acting through an interface that maximizes the effectiveness of their residual motor function. This is called a "body-machine interface" because it maps the motions of the upper-body (arms and shoulders) to the space of device control signals in an optimal way. In this way, paralyzed persons that cannot operate a joystick controller because of lack of hand mobility can effectively use their whole upper body as virtual joystick device. An important characteristic of the proposed approach is that it is based on the possibility to control a computer or a wheelchair by bodily movements through an interactive learning process, in which the interface adapts itself to the subject's mobility and the subject learns to act through the interface. This study aims at developing and testing the customization of this interface to a group of SCI participants with tetraplegia, resulting from high-level cervical injury. The proposed research is organized in three specific aims:

(Aim 1) To develop new functional capabilities in persons with spinal cord injury by customizing a body-machine interface to their individual upper body mobility. After fitting the interface to the residual movements of each subject, participants will practice computer games aimed at training two classes of control actions: operating a virtual joystick and operating a virtual keyboard. This study will test the ability of the subjects to perform skilled maneuvers with a simulated wheelchair.

(Aim 2.) To test the hypothesis that practicing the upper-body control of personalized interfaces results in significant physical and psychological benefits after spinal-cord injury. A study will evaluate and quantify the impact of the practicing functional upper-body motions on the mobility of the shoulder and arms by conventional clinical methods and by measuring the subjects' ability to generate coordinated upper body movements and to apply isometric forces. Other studies under this aim will evaluate the effects of operating the body-machine interface on musculoskeletal pain and on the mood and mental state of the participants.

(Aim 3) To train spinal-cord injury survivors to skillfully operate a powered wheelchair using their enhanced upper body motor skills and customized interface parameters. Finally, the last study will test the hypothesis that the skills learned through practice in the virtual environment are retained for the control of an actual powered wheelchair. After reaching stable performance in the simulated wheelchair, subjects will practice the control of the physical wheelchair in safe a testing environment.

If successful, this study will lead to effective operation of a highly customized interface that adapts to the residual motor capability of its users. Physical and psychological benefits are expected to derive from the sustained and coordinated activity associated with the use of this body-machine interface

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65
  • Injuries at C3-C6 level, complete (ASIA A) or incomplete (ASIA B and C)
  • Able to follow simple commands
  • Able to speak or respond to questions

Exclusion Criteria:

  • Presence of tremors, spasm and other significant involuntary movements
  • Cognitive impairment
  • Deficit of visuo-spatial orientation
  • Concurrent pressure sores or urinary tract infection
  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: NCT01608438

Contacts
Contact: Ferdinando A Mussa-Ivaldi, PhD 3122381230 sandro@northwestern.edu

Locations
United States, Illinois
Rehabilitation Institute of Chicago Recruiting
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Rehabilitation Institute of Chicago
Investigators
Principal Investigator: Ferdinando A Mussa-Ivaldi, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Ferdinando Mussa-Ivaldi, Senior Research Scientist, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier: NCT01608438     History of Changes
Other Study ID Numbers: STU00057856
Study First Received: April 16, 2012
Last Updated: December 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rehabilitation Institute of Chicago:
Body-machine interface
Customization
Upper-body motion
Motor learning
Assistive Devices
Wheelchair
Computer keyboard

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 24, 2014