Cognitive-based Prosthetics to Improve Grasp and Reaching After SCI
Primary Purpose
Spinal Cord Injuries, Hand Weakness
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognition glove
Sensory brace
Sponsored by
About this trial
This is an interventional device feasibility trial for Spinal Cord Injuries
Eligibility Criteria
Inclusion Criteria:
- SCI occurred greater than 12 months ago
- SCI occurred between levels C1-T1
- Hand weakness: score of 2, 3, or 4 out of 5 on manual muscle testing of finger extension, finger flexion, or finger abduction in either hand
Exclusion Criteria:
- History of other serious brain or spinal cord injuries
- History of seizures
- Ventilator dependence; open tracheostomy
- Use of medications that significantly lower seizure threshold
- History of significant cognitive deficits
- Open skin lesions over the face, neck, shoulders, arms, or hands
- Pregnancy
Sites / Locations
- James J. Peters VA Medical Center, Bronx, NYRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
No cognitive feedback
Intermediate feedback.
Enhanced feedback
Arm Description
Perform task without cognitive feedback.
Perform task with intermediate feedback.
Perform task with virtual reality and/or haptic feedback.
Outcomes
Primary Outcome Measures
Time to achieve secure grasp upon initial contact
Time to achieve secure grasp. Lower time is better.
Time to complete pick-up and placement of object
Time to pick up and re-place object. Lower time is better.
Secondary Outcome Measures
Motion pathlength in moving object
Pathlength during reaching/grasping/moving. Shorter is better.
Error in placing object onto target
Errors during reaching/grasping/moving. Fewer is better.
Full Information
NCT ID
NCT04577573
First Posted
September 14, 2020
Last Updated
November 16, 2022
Sponsor
VA Office of Research and Development
Collaborators
Stevens Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT04577573
Brief Title
Cognitive-based Prosthetics to Improve Grasp and Reaching After SCI
Official Title
Cognitive-based Rehabilitation Platform of Hand Grasp After Spinal Cord Injury Using Virtual Reality and Instrumented Wearables
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
October 28, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Stevens Institute of Technology
4. Oversight
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
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Rehabilitation of functional movements after spinal cord injury (SCI) requires commitment and engagement to the processes of physical therapy. Outcomes may be improved by techniques that strengthen cognitive connections between users and physical therapy exercises.
The investigators will investigate combinations of virtual reality and innovative wearable technology to accelerate rehabilitation of hand grasp and reach. These devices use multi-sensory feedback to enhance the sense of agency, or feelings of control, and better train movements during physical rehabilitation exercises. The investigators will measure the effect of these devices on improving the speed, efficiency, and accuracy of performed movements in Veterans with SCI.
Detailed Description
Spinal cord injury (SCI) at the cervical level impairs hand function severely compromises performance of activities of daily living. The physical rehabilitation process requires commitment by the participant to achieve meaningful gains in function. Rehabilitation approaches that are cognitively engaging can facilitate greater commitment to practice and improved movement learning.
The investigators propose to develop innovative platforms that utilize virtual reality (VR) and instrumented wearables that enhance cognitive factors during motor learning of hand grasp and reach after SCI. These factors include greater sense of agency, or perception of control, and multi-sensory feedback. Sense of agency is implicated with greater movement control, and various sensory feedback modalities (visual, audio, and haptic) are proven effective in movement training. However, these factors are not well considered in traditional physical therapy approaches.
The investigators have developed two novel cognitive-based platforms for rehabilitating grasp and reach function and propose to test each platform in Veterans with chronic SCI at the cervical level.
Aim 1 will investigate how the "cognition" glove may improve functional grasp. This glove includes force and flex sensors that provide inputs to a machine learning algorithm trained to predict when secure grasp is achieved. The glove alerts the user of secure grasp through onboard sensory modules providing visual (LED), audio (beeper), and tactile (vibrator) feedback. During training, feedback is provided at gradually shorter time-intervals to progressively induce agency based on the neuroscience principle of 'intentional binding'. This principle suggests that with greater agency, one perceives their action (i.e., secure grasp) is more coupled in time to a sensory consequence (i.e., glove feedback). The glove is user-ready, and now has compatibility with customized VR applications to provide enhanced sensory feedback through engaging and customized visual and sound alerts. The investigators hypothesize that enhanced feedback in VR will produce even greater improvements in grasp performance than onboard feedback alone.
Aim 2 will investigate how Veterans with SCI may learn greater arm muscle control during virtual reaching while using a "sensory" brace that provides isometric resistance to one arm to elicit electromyography (EMG) patterns that can drive a virtual arm. The person receives visual feedback from VR and muscle tendon haptic feedback from the brace during training. Tendon stimulation can elicit movement sensations that modulate muscle activation patterns. The VR feedback will provide conscious movement training cues while vibration feedback will subconsciously elicit more distinct EMG patterns based on cluster analysis. The investigators hypothesize that the promotion of distinct EMG patterns, achieved by maximizing inter-cluster distances, will improve performance of a reach-to-touch task.
Importantly, the concept of strengthening cognitive agency and learning of movement using wearable technology, multi-sensory feedback, and virtual reality during physical training will be applicable to all forms of neuromuscular impairment, including stroke and traumatic brain injury in addition to SCI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Hand Weakness
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
At each visit, prototype cognitive prosthetic devices will be tested under 3 conditions:
No feedback, simple feedback, and enhanced feedback. Outcomes will include time taken for successful movements; and accuracy of movements.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No cognitive feedback
Arm Type
Active Comparator
Arm Description
Perform task without cognitive feedback.
Arm Title
Intermediate feedback.
Arm Type
Active Comparator
Arm Description
Perform task with intermediate feedback.
Arm Title
Enhanced feedback
Arm Type
Experimental
Arm Description
Perform task with virtual reality and/or haptic feedback.
Intervention Type
Device
Intervention Name(s)
Cognition glove
Intervention Description
The investigators have developed and tested a functional prototype of an instrumented glove to alert the user about secure grasp of objects. Onboard force and flex sensors provide inputs to a machine learning algorithm (artificial neural network, ANN) to estimate secure grasp based on previously collected training data. The glove enhances agency by alerting the user to secure grasp through sensory feedback modules (visual - LED, audio - beeper, tactile - vibrator).
Intervention Type
Device
Intervention Name(s)
Sensory brace
Intervention Description
A a size- and position-adjustable arm brace with weight-support capability and housing for vibration motors and EMG sensors. Position adjustment allows for physical therapists to find and recommend arm postures that are clinically relevant to
each person. The participant can then isometrically push/resist against the brace to strengthen target muscles while performing VR reach-to-touch. The person will receive visual feedback from the virtual environment to train movement performance and vibrotactile feedback at tendons to subconsciously adjust their muscle activation patterns
Primary Outcome Measure Information:
Title
Time to achieve secure grasp upon initial contact
Description
Time to achieve secure grasp. Lower time is better.
Time Frame
Iimmediately after the procuedure
Title
Time to complete pick-up and placement of object
Description
Time to pick up and re-place object. Lower time is better.
Time Frame
Iimmediately after the procuedure
Secondary Outcome Measure Information:
Title
Motion pathlength in moving object
Description
Pathlength during reaching/grasping/moving. Shorter is better.
Time Frame
Iimmediately after the procuedure
Title
Error in placing object onto target
Description
Errors during reaching/grasping/moving. Fewer is better.
Time Frame
Iimmediately after the procuedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
SCI occurred greater than 12 months ago
SCI occurred between levels C1-T1
Hand weakness: score of 2, 3, or 4 out of 5 on manual muscle testing of finger extension, finger flexion, or finger abduction in either hand
Exclusion Criteria:
History of other serious brain or spinal cord injuries
History of seizures
Ventilator dependence; open tracheostomy
Use of medications that significantly lower seizure threshold
History of significant cognitive deficits
Open skin lesions over the face, neck, shoulders, arms, or hands
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noam Y Harel, MD PhD
Phone
(718) 584-9000
Ext
1742
Email
Noam.Harel@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noam Y. Harel, MD PhD
Organizational Affiliation
James J. Peters Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
James J. Peters VA Medical Center, Bronx, NY
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raviraj Nataraj, PhD
Phone
201-216-3555
Email
rnataraj@stevens.edu
First Name & Middle Initial & Last Name & Degree
Noam Y. Harel, MD PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
A Limited Dataset (LDS) will be shared in electronic format pursuant to a VA-approved Data Use Agreement.
This will include all outcomes data and deidentified demographics.
Individually Identifiable Data will be shared pursuant to valid HIPAA Authorization, Informed Consent, and an appropriate written agreement limiting use of the data to the conditions as described in the authorization and consent, and a written assurance from the recipient that the information will be maintained in accordance with the security requirements of 38 CFR Part 1.466.
IPD Sharing Time Frame
Upon publication.
IPD Sharing Access Criteria
Individually Identifiable Data will be shared pursuant to valid HIPAA Authorization, Informed Consent, and an appropriate written agreement limiting use of the data to the conditions as described in the authorization and consent, and a written assurance from the recipient that the information will be maintained in accordance with the security requirements of 38 CFR Part 1.466.
Learn more about this trial
Cognitive-based Prosthetics to Improve Grasp and Reaching After SCI
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