Hand Orthosis for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

Overseen by Joel Stein, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Columbia University

Disqualifiers: Contractures, Severe spasticity, Open wounds, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing the MyHand-SCI device, which helps people with C6-C7 spinal cord injuries use their hands better. The device combines physical support and smart technology to improve hand movements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the MyHand-SCI Device, MyHand-SCI Orthosis, and MyHand-SCI Robotic Hand Orthosis treatment?

Research on similar devices, like the OrthoJacket and the Bionic Glove, shows that combining mechanical support with functional electrical stimulation (FES) can help restore hand function in people with spinal cord injuries, improving their independence in daily activities. ^{1 2 3 4 5}

How is the MyHand-SCI Device treatment different from other treatments for spinal cord injury?

The MyHand-SCI Device is unique because it combines soft robotics and functional electrical stimulation (FES) to assist and restore hand function in people with spinal cord injury. This approach is different from traditional hand assist devices, which can be bulky and complex, as it offers a lightweight and compact solution that enhances independence in daily activities. ^{1 2 3 4 5}

Research Team

Joel Stein, MD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for individuals with C6-C7 spinal cord injury who are at least 6 months post-injury and have significantly reduced hand and finger function. They must be able to consent to the study. People with open wounds, severe upper limb pain, intense spasticity, or fixed contractures that limit arm use cannot participate.

Inclusion Criteria

My hand and finger control is greatly reduced due to my spinal cord injury.

Able to provide informed consent

I have a spinal cord injury at C6-C7 and my arms don't work well, 6 months after the injury.

Exclusion Criteria

I cannot use my hand or arm well because they are stiff and cannot move.

I have open wounds or my skin tears easily.

I have constant severe pain in my arm.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Device Testing

Subjects will attend 1-20 sessions to trial a variety of the MyHand-SCI device controls and/or components. Participants will practice various grasp and release activities with the device.

Up to 20 sessions

1-20 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after device testing

Up to 2 years

Treatment Details

Interventions

• MyHand-SCI Device (Active Hand Orthosis)

Trial Overview The MyHand-SCI trial is testing a device designed to help people with specific spinal cord injuries regain hand functions. Participants will use the MyHand-SCI orthosis, which aims to improve their ability to perform daily tasks by enhancing motor control and strength in their hands.

Participant Groups

Group I: MyHand-SCI Device Testing Experimental Treatment 1 Intervention

Subjects will attend 1-20 sessions (of approximately 90 mins) to trial a variety of the MyHand-SCI device controls and/or components. Participants will practice various grasp and release activities with the device

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Dr. Katrina Armstrong

Columbia University

Chief Executive Officer

MD from Johns Hopkins University, MS in Epidemiology from Harvard School of Public Health

Dr. Katrina Armstrong

Columbia University

Chief Medical Officer

MD from Harvard Medical School

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Jordan Gladman

National Institute of Neurological Disorders and Stroke (NINDS)

Chief Medical Officer

MD from Harvard Medical School

Walter J. Koroshetz

National Institute of Neurological Disorders and Stroke (NINDS)

Chief Executive Officer since 2007

MD from the University of Chicago

Findings from Research

The OrthoJacket is a novel non-invasive neuro-orthosis designed to restore hand and arm functions in high tetraplegic spinal cord injury patients, aiming to improve their independence in daily activities.

This system combines mechanical stabilization with functional electrical stimulation and flexible fluidic actuators, allowing for both functional restoration and training, while adapting to individual anatomical and neurological needs through advanced sensor systems and user interfaces.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OrthoJacket: an active FES-hybrid orthosis for the paralysed upper extremity. Schill, O., Wiegand, R., Schmitz, B., et al.[2011]

The Bionic Glove, a functional electrical stimulation device, significantly enhances hand function in individuals with C6-C7 spinal cord injuries, as demonstrated by a mean peak force increase from 2.6N to 11.3N during grasping tasks.

In a study involving nine participants over a year, the glove improved the ability to complete manual tasks and reduced perceived difficulty, indicating its efficacy for daily use in enhancing hand functionality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The bionic glove: an electrical stimulator garment that provides controlled grasp and hand opening in quadriplegia. Prochazka, A., Gauthier, M., Wieler, M., et al.[2022]

Wearable devices using soft robotics (SR) and functional electrical stimulation (FES) show promise in aiding hand function recovery for individuals with spinal cord injury (SCI), based on a review of 37 studies that reported functional outcomes.

Key limitations identified include the need for improvements in user intent detection, portability, and calibration of these devices, which hinder their transition from research prototypes to practical clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soft robotics and functional electrical stimulation advances for restoring hand function in people with SCI: a narrative review, clinical guidelines and future directions. Cardoso, LRL., Bochkezanian, V., Forner-Cordero, A., et al.[2022]

The GRIPIT hand assist device is a lightweight and compact solution designed to help individuals with spinal cord injuries perform a tripod grasp, improving their ability to write and manipulate small objects.

In a study with four participants, GRIPIT demonstrated better writing performance in terms of sensation, legibility, and accuracy compared to conventional penholders, primarily due to its ability to provide sufficient grasp force without requiring complex finger movements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and assessment of a hand assist device: GRIPIT. Kim, B., In, H., Lee, DY., et al.[2018]

References

1. Germany pubmed.ncbi.nlm.nih.gov

OrthoJacket: an active FES-hybrid orthosis for the paralysed upper extremity. [2011]

2. United States pubmed.ncbi.nlm.nih.gov

The bionic glove: an electrical stimulator garment that provides controlled grasp and hand opening in quadriplegia. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Soft robotics and functional electrical stimulation advances for restoring hand function in people with SCI: a narrative review, clinical guidelines and future directions. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Development and assessment of a hand assist device: GRIPIT. [2018]

5. India pubmed.ncbi.nlm.nih.gov

Compliance with Long-Term Use of Orthoses Following Spinal Cord Injury. [2022]