Hand Orthosis for Spinal Cord Injury

Overseen By Lauren Winterbottom, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Contractures, Severe spasticity, Open wounds, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called MyHand-SCI, designed to assist individuals with hand function after a spinal cord injury at levels C6-C7. The goal is to evaluate the effectiveness of the device's hardware and software in improving grip and release activities. Individuals who have experienced a spinal cord injury in this area for more than six months and have difficulty with hand and finger movement might find this trial suitable. Participants will use the device in multiple sessions to assess its impact on hand use. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance hand function for many.

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 prior data suggests that the MyHand-SCI device is safe for individuals with C6-C7 spinal cord injury?

Research has shown that the MyHand-SCI device has been tested with individuals who have C6 spinal cord injuries and has shown promise in improving hand function. An initial study demonstrated that the device helped users increase hand strength and the ability to hold objects without losing control, suggesting good user tolerance. While specific safety details are not provided, the testing phase indicates that the device is still under assessment for safety and effectiveness. Early results are positive, but ongoing testing remains crucial to fully understand any potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The MyHand-SCI device is unique because it offers a hands-on approach for people with spinal cord injuries to regain hand function. Unlike traditional therapies that might focus on physical therapy exercises or electrical stimulation, the MyHand-SCI device allows users to actively engage in grasp and release activities with a customized orthotic device. This device stands out because it lets users trial various controls and components, potentially offering more adaptability and precision in restoring hand movement. Researchers are excited about this treatment because it could lead to improved independence and quality of life for individuals living with spinal cord injuries.

What evidence suggests that the MyHand-SCI device is effective for improving hand function in C6-C7 spinal cord injury?

Research has shown that the MyHand-SCI device, which participants in this trial will test, can help people with C6-C7 spinal cord injuries use their hands more effectively. This device provides physical support and uses software to assist with hand movements like grabbing and releasing objects. Early results suggest that users might find it easier to perform everyday tasks. While more data is being gathered, the device aims to help people with these spinal cord injuries become more independent. ^{1 3 4 5 6}

Who Is on the Research Team?

Joel Stein, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• MyHand-SCI Device

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.

How Is the Trial Designed?

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+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

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 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 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]

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]

In a study of 202 spinal cord injury patients, 67.6% continued to use their prescribed orthoses long-term, indicating a significant level of adherence to these assistive devices.

However, 32.4% of participants stopped using their orthoses, primarily due to difficulties in putting them on and taking them off, improvements in their condition, and mechanical issues with the devices, highlighting the need for regular patient evaluations and adjustments to the orthoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with Long-Term Use of Orthoses Following Spinal Cord Injury. Yemisci, OU., Ozen, S., Saracgil Cosar, SN., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05553457

MyHand-SCI: an Active Hand Orthosis for Spinal Cord Injury The purpose of this study is to develop and test the hardware and software components of the MyHand-SCI device to assist with hand function for individuals ...

2. withpower.com withpower.com/trial/phase-wounds-and-injuries-8-2022-775c7

Hand Orthosis for Spinal Cord Injury 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 ...

3. trial.medpath.com trial.medpath.com/clinical-trial/d2b9764fab6af577/wearable-robotic-hand-orthosis-c6-c7-spinal-cord-injury

MyHand-SCI: an Active Hand Orthosis for Spinal Cord Injury The purpose of this study is to develop and test the hardware and software components of the MyHand-SCI device to assist with hand function ...

4. clinicaltrial.be clinicaltrial.be/en/details/22880?per_page=100&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

MyHand-SCI: an Active Hand Orthosis for Spinal Cord Injur... The purpose of this study is to develop and test the hardware and software components of the MyHand-SCI device to assist with hand function ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10693050/

Mixed methods usability evaluation of an assistive ... We evaluated the short-term usability of the RELab tenoexo, a RHO for hand function assistance, in 15 users with tetraplegia after a spinal cord injury.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40041101/

Grasp Force Assistance via Throttle-based Wrist Angle Control ... A pilot case study with a person with C6 spinal cord injury shows an improvement in functional grasping and grasping force, as well as a preserved ability to ...