Cognitive-based Prosthetics to Improve Grasp and Reaching After SCI

NCT04577573 | Completed Results FDA Device

• 1 other identifier: B3582-P
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Hand Weakness

Outcome Measures

Primary Outcomes (3)

• Percent Change in Time to Achieve Secure Grasp (Cognition Glove Only)

  Percent change in time (seconds) to achieve secure grasp. Lower time is better.

  Baseline and Following the 6 hour lab session, assessed while performing the task

• Percent Change in Time to Complete Pick-up and Placement of Object-Cognition Glove

  Percent change in time (seconds) to pick up and re-place object. Lower time is better.

  Baseline and Following the 6 hour lab session, assessed while performing the task

• Percent Change in Time to Complete Trial-Sensory Brace

  Percent change in time (seconds) to complete target reaching trials in VR environment. Lower time is better.

  Baseline and Following the 6 hour lab session, assessed while performing the task

Secondary Outcomes (3)

• Percent Change in Motion Pathlength in Moving Object-Cognition Glove

  Baseline and Following the 6 hour lab session, assessed while performing the task

• Percent Change in Motion Pathlength Toward Virtual Targets-Sensory Brace

  Baseline and Following the 6 hour lab session, assessed while performing the task

• Error in Placing Object Onto Target (Cognition Glove Only)

  Baseline and Following the 6 hour lab session, assessed while performing the task

Study Arms (3)

No cognitive feedback

ACTIVE COMPARATOR

Perform task without cognitive feedback.

Device: Cognition glove; Device: Sensory brace

Intermediate feedback.

ACTIVE COMPARATOR

Perform task with intermediate feedback.

Device: Cognition glove; Device: Sensory brace

Enhanced feedback

EXPERIMENTAL

Perform task with virtual reality and/or haptic feedback.

Device: Cognition glove; Device: Sensory brace

Interventions

Cognition glove DEVICE

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).

Enhanced feedback; Intermediate feedback.; No cognitive feedback

Sensory brace DEVICE

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

Enhanced feedback; Intermediate feedback.; No cognitive feedback

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Stevens Institute of Technology: collaborator

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468-3904, United States

Location

Related Publications (1)

• Liu M, Wilder S, Sanford S, Saleh S, Harel NY, Nataraj R. Training with Agency-Inspired Feedback from an Instrumented Glove to Improve Functional Grasp Performance. Sensors (Basel). 2021 Feb 7;21(4):1173. doi: 10.3390/s21041173.

  PMID: 33562342 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

Small number of participants in this pilot study.

Results Point of Contact

• Title: Noam Y. Harel, MD, PhD
• Organization: James J. Peters VA Medical Center

noam.harel@va.gov

718-584-9000

Study Officials

• Noam Y. Harel, MD PhD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: October 8, 2020
• Study Start: May 17, 2021
• Primary Completion: October 17, 2023
• Study Completion: November 30, 2023
• Last Updated: April 25, 2025
• Results First Posted: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon publication.
• 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.

Locations

US (1)