Spinal Cord InjuriesNCT04577573
Cognitive-based Prosthetics to Improve Grasp and Reaching After SCI
A study testing Cognition glove and Sensory brace in people with Spinal Cord Injuries and Hand Weakness, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Hand Weakness
- What is being tested?
- Cognition glove and Sensory brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2021to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468-3904
About this study
Official title: Cognitive-based Rehabilitation Platform of Hand Grasp After Spinal Cord Injury Using Virtual Reality and Instrumented Wearables
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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Hand Weakness
- Being tested
- Cognition glove, Sensory brace
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognition gloveDevice
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 braceDevice
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
| Study group | Role | What they receive |
|---|---|---|
| No cognitive feedback | Active comparator | Perform task without cognitive feedback. Receives: Device: Cognition glove; Device: Sensory brace |
| Intermediate feedback. | Active comparator | Perform task with intermediate feedback. Receives: Device: Cognition glove; Device: Sensory brace |
| Enhanced feedback | Experimental | Perform task with virtual reality and/or haptic feedback. Receives: Device: Cognition glove; Device: Sensory brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Time to Achieve Secure Grasp (Cognition Glove Only)
Percent change in time (seconds) to achieve secure grasp. Lower time is better.
Measured: 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.
Measured: 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.
Measured: 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
Percent change in pathlength during reaching/grasping/moving. Shorter is better.
Measured: Baseline and Following the 6 hour lab session, assessed while performing the task
Percent Change in Motion Pathlength Toward Virtual Targets-Sensory Brace
Percent change in pathlength during reaching virtual targets. Shorter is better.
Measured: Baseline and Following the 6 hour lab session, assessed while performing the task
Error in Placing Object Onto Target (Cognition Glove Only)
Error in completing placement of object onto target.
Measured: Baseline and Following the 6 hour lab session, assessed while performing the task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start17 May 2021
- Primary completion17 Oct 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Stevens Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Noam Y. Harel, MD PhD, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577573
- Sponsor's protocol ID
- B3582-P
- Status last verified
- Apr 2025
- First submitted
- 14 Sep 2020
- Last updated
- 25 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 33562342
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-based Rehabilitation Platform of Hand Grasp After Spinal Cord Injury Using Virtual Reality and Instrumented Wearables
- ClinicalTrials.gov ID
- NCT04577573
- Acronym / sponsor ID
- B3582-P
- Conditions
- Spinal Cord Injuries, Hand Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Stevens Institute of Technology
- Study start
- 17 May 2021 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Posted 25 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| No cognitive feedback | Active comparator | Device: Cognition glove, Device: Sensory bracePerform task without cognitive feedback. |
| Intermediate feedback. | Active comparator | Device: Cognition glove, Device: Sensory bracePerform task with intermediate feedback. |
| Enhanced feedback | Experimental | Device: Cognition glove, Device: Sensory bracePerform task with virtual reality and/or haptic feedback. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognition gloveThe 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). | Device | Enhanced feedback, Intermediate feedback., No cognitive feedback |
| Sensory braceA 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 | Device | Enhanced feedback, Intermediate feedback., No cognitive feedback |
Primary outcome
Percent Change in Time to Achieve Secure Grasp (Cognition Glove Only)
Time frame: Baseline and Following the 6 hour lab session, assessed while performing the task
Percent 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 Glove
Time frame: Baseline and Following the 6 hour lab session, assessed while performing the task
Percent change in time (seconds) to pick up and re-place object. Lower time is better.
Percent Change in Time to Complete Trial-Sensory Brace
Time frame: Baseline and Following the 6 hour lab session, assessed while performing the task
Percent change in time (seconds) to complete target reaching trials in VR environment. Lower time is better.
3 secondary outcomes
Percent Change in Motion Pathlength in Moving Object-Cognition Glove
Time frame: Baseline and Following the 6 hour lab session, assessed while performing the task
Percent Change in Motion Pathlength Toward Virtual Targets-Sensory Brace
Time frame: Baseline and Following the 6 hour lab session, assessed while performing the task
Error in Placing Object Onto Target (Cognition Glove Only)
Time frame: Baseline and Following the 6 hour lab session, assessed while performing the task
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33562342Liu 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noam Y. Harel, MD PhD principal investigator
James J. Peters Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognition glove and Sensory brace in people with Spinal Cord Injuries and Hand Weakness, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Time to Achieve Secure Grasp (Cognition Glove Only) (time frame: Baseline and Following the 6 hour lab session, assessed while performing the task). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04577573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.