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Cognitive-based Prosthetics to Improve Grasp and Reaching After SCI

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04577573
Enrollment
13
Registered
2020-10-08
Start date
2021-05-17
Completion date
2023-11-30
Last updated
2025-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand Weakness, Spinal Cord Injuries

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.

Interventions

DEVICECognition 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).

DEVICESensory 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

Sponsors

Stevens Institute of Technology
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percent Change in Time to Achieve Secure Grasp (Cognition Glove Only)Baseline and Following the 6 hour lab session, assessed while performing the taskPercent change in time (seconds) to achieve secure grasp. Lower time is better.
Percent Change in Time to Complete Pick-up and Placement of Object-Cognition GloveBaseline and Following the 6 hour lab session, assessed while performing the taskPercent change in time (seconds) to pick up and re-place object. Lower time is better.
Percent Change in Time to Complete Trial-Sensory BraceBaseline and Following the 6 hour lab session, assessed while performing the taskPercent change in time (seconds) to complete target reaching trials in VR environment. Lower time is better.

Secondary

MeasureTime frameDescription
Percent Change in Motion Pathlength in Moving Object-Cognition GloveBaseline and Following the 6 hour lab session, assessed while performing the taskPercent change in pathlength during reaching/grasping/moving. Shorter is better.
Percent Change in Motion Pathlength Toward Virtual Targets-Sensory BraceBaseline and Following the 6 hour lab session, assessed while performing the taskPercent change in pathlength during reaching virtual targets. Shorter is better.
Error in Placing Object Onto Target (Cognition Glove Only)Baseline and Following the 6 hour lab session, assessed while performing the taskError in completing placement of object onto target.

Countries

United States

Participant flow

Participants by arm

ArmCount
Cognition Glove
Participants wear an instrumented glove on one hand while performing reaching and grasping tasks.
4
Sensory Brace
Participants wear an instrumented brace on one shoulder/upper arm while performing reaching and grasping tasks.
7
Participated in Both Cognition Glove and Sensory Brace
Participated in both Cognition Glove and Sensory Brace experiments
2
Total13

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyTechnical - invalid protocol020

Baseline characteristics

CharacteristicCognition GloveSensory BraceParticipated in Both Cognition Glove and Sensory BraceTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
4 Participants7 Participants2 Participants13 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants0 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3 Participants7 Participants2 Participants12 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
4 Participants5 Participants2 Participants11 Participants
Sex: Female, Male
Female
2 Participants1 Participants0 Participants3 Participants
Sex: Female, Male
Male
2 Participants6 Participants2 Participants10 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 60 / 7
other
Total, other adverse events
0 / 61 / 7
serious
Total, serious adverse events
0 / 60 / 7

Outcome results

Primary

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

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

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

Population: Data invalid for one participant in No cognitive feedback, 2 participants in Intermediate feedback, and 1 participant in Enhanced feedback

ArmMeasureValue (MEAN)Dispersion
No Cognitive FeedbackPercent Change in Time to Achieve Secure Grasp (Cognition Glove Only)39.9 % change in time to secure graspStandard Deviation 65.5
Intermediate Feedback.Percent Change in Time to Achieve Secure Grasp (Cognition Glove Only)-14.6 % change in time to secure graspStandard Deviation 11.9
Enhanced FeedbackPercent Change in Time to Achieve Secure Grasp (Cognition Glove Only)10.1 % change in time to secure graspStandard Deviation 54.9
Primary

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.

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

ArmMeasureValue (MEAN)Dispersion
No Cognitive FeedbackPercent Change in Time to Complete Pick-up and Placement of Object-Cognition Glove20.2 % change in time to pick-up/placementStandard Deviation 19.7
Intermediate Feedback.Percent Change in Time to Complete Pick-up and Placement of Object-Cognition Glove7.9 % change in time to pick-up/placementStandard Deviation 25.8
Enhanced FeedbackPercent Change in Time to Complete Pick-up and Placement of Object-Cognition Glove-24.4 % change in time to pick-up/placementStandard Deviation 24.3
Primary

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.

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

Population: Data invalid for two participants in each condition.

ArmMeasureValue (MEAN)Dispersion
No Cognitive FeedbackPercent Change in Time to Complete Trial-Sensory Brace18.6 % change in time to complete trialStandard Deviation 9.1
Intermediate Feedback.Percent Change in Time to Complete Trial-Sensory Brace3.3 % change in time to complete trialStandard Deviation 12.5
Secondary

Error in Placing Object Onto Target (Cognition Glove Only)

Error in completing placement of object onto target.

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

Population: After initiating the study, it was quickly determined that this outcome measure was irrelevant. All participants are able to complete the task. Outcome measures 1 and 2 capture the impact of difficulty grasping and moving the object without requiring a separate subjective measure of 'error'.

ArmMeasureValue (MEAN)Dispersion
No Cognitive FeedbackError in Placing Object Onto Target (Cognition Glove Only)0 Error in placing object onto target.Standard Deviation 0
Intermediate Feedback.Error in Placing Object Onto Target (Cognition Glove Only)0 Error in placing object onto target.Standard Deviation 0
Enhanced FeedbackError in Placing Object Onto Target (Cognition Glove Only)0 Error in placing object onto target.Standard Deviation 0
Secondary

Percent Change in Motion Pathlength in Moving Object-Cognition Glove

Percent change in pathlength during reaching/grasping/moving. Shorter is better.

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

ArmMeasureValue (MEAN)Dispersion
No Cognitive FeedbackPercent Change in Motion Pathlength in Moving Object-Cognition Glove39.1 % change in motion pathlengthStandard Deviation 13.1
Intermediate Feedback.Percent Change in Motion Pathlength in Moving Object-Cognition Glove21.9 % change in motion pathlengthStandard Deviation 31.2
Enhanced FeedbackPercent Change in Motion Pathlength in Moving Object-Cognition Glove-12.4 % change in motion pathlengthStandard Deviation 19.1
Secondary

Percent Change in Motion Pathlength Toward Virtual Targets-Sensory Brace

Percent change in pathlength during reaching virtual targets. Shorter is better.

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

Population: Data invalid for two participants in each condition.

ArmMeasureValue (MEAN)Dispersion
No Cognitive FeedbackPercent Change in Motion Pathlength Toward Virtual Targets-Sensory Brace17.7 % change in motion pathlengthStandard Deviation 10.6
Intermediate Feedback.Percent Change in Motion Pathlength Toward Virtual Targets-Sensory Brace1.4 % change in motion pathlengthStandard Deviation 6.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026