Cognitive-based Prosthetics to Improve Grasp and Reaching After SCI

Spinal Cord Injuries Clinical Trial

Official title:

Cognitive-based Rehabilitation Platform of Hand Grasp After Spinal Cord Injury Using Virtual Reality and Instrumented Wearables

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04577573
• Other study ID #: B3582-P
• Status: Completed
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: December 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 30, 2023
• Est. primary completion date: October 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hand Weakness
• Spinal Cord Injuries

Intervention

Device:
• Cognition glove
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).
• Sensory brace
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

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center, Bronx, NY	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Stevens Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to achieve secure grasp upon initial contact	Time to achieve secure grasp. Lower time is better.	Iimmediately after the procuedure
Primary	Time to complete pick-up and placement of object	Time to pick up and re-place object. Lower time is better.	Iimmediately after the procuedure
Secondary	Motion pathlength in moving object	Pathlength during reaching/grasping/moving. Shorter is better.	Iimmediately after the procuedure
Secondary	Error in placing object onto target	Errors during reaching/grasping/moving. Fewer is better.	Iimmediately after the procuedure