MyHand Device for Stroke-Related Hand Impairment

(MyHand 2 Trial)

Recruiting at 1 trial location

Overseen By Joel Stein, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Other neurological, orthopedic conditions, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 year

25 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is designed to further develop and test the hardware and software components of the MyHand device based on user feedback and results from our pilot study. The goal is to refine the device so that is more effective and easier for stroke patients to use to increase their hand function.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the MyHand Device treatment for stroke-related hand impairment?

Research shows that similar devices, like a 3D-printed hand device, improved hand strength and function in stroke patients. Another study found that using an active orthosis helped stroke survivors improve their ability to perform tasks like lifting a can. These findings suggest that the MyHand Device could be effective in aiding hand rehabilitation after a stroke. ^{1 2 3 4 5}

Is the MyHand Device safe for human use?

Research on similar devices, like the RobHand and a robotic exoskeleton hand device, shows they are generally safe, with no significant adverse events reported. Participants found these devices comfortable and user-friendly, suggesting that the MyHand Device may also be safe for human use. ^{4 5 6 7 8}

How does the MyHand Device treatment differ from other treatments for stroke-related hand impairment?

The MyHand Device is unique because it is a multifunctional, 3D-printed hand orthosis designed for home rehabilitation, allowing for a variety of grasping motions and improving hand strength and function. Unlike other devices that may only support a single motion or use abnormal postures, this device offers a more natural and comprehensive approach to hand rehabilitation. ^{3 5 9 10 11}

Research Team

Joel Stein

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for adults over 18 who had a stroke at least six months ago and now have weakness in one hand, making daily tasks hard. They must be able to move their fingers fully, follow directions well, and control the upper part of the affected arm. People with other brain or nerve conditions or other issues with that arm can't join.

Inclusion Criteria

I am over 18 years old.

I can understand and follow instructions.

My last stroke was more than six months ago.

Exclusion Criteria

I have a neurological condition other than stroke.

I have other bone or joint issues in my arm.

I have severe muscle stiffness in my arm that affects how devices fit.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will use the MyHand device during repetitive grasp and release tasks

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• MyHand Device

Trial Overview The MyHand device is being tested to see if it helps improve hand function in stroke patients. The study involves refining this assistive technology based on feedback from earlier tests to make it more effective and user-friendly.

Participant Groups

Group I: MyHand Treatment Experimental Treatment 1 Intervention

Participants will use the MyHand device during repetitive grasp and release tasks.

MyHand Device is already approved in United States for the following indications:

Approved in United States as MyHand Device for:

• Stroke rehabilitation
• Upper limb impairment

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+

Findings from Research

In a study involving eight sub-acute stroke patients, the use of a functional hand orthosis combined with electrical stimulation led to significant improvements in hand function, with a median increase of 19.2 points on the Action Research Arm Test after six weeks of therapy.

Patients reported high levels of intrinsic motivation and self-regulation while using the orthosis, indicating that this combination therapy not only enhances physical capabilities but also positively affects the patients' engagement in their rehabilitation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a functional hand orthosis combined with electrical stimulation adjunct to arm-hand rehabilitation in subacute stroke patients with a severely to moderately affected hand function. Franck, JA., Smeets, RJEM., Seelen, HAM.[2020]

A pilot study involving five stroke survivors demonstrated the feasibility of using electromyographic signals to control an active orthosis, the J-Glove, for hand therapy, with participants completing 18 training sessions over 6 weeks.

All subjects showed improvement in lifting a can as part of the Wolf Motor Function Test, and three subjects improved on the Action Research Arm Test, indicating potential benefits of the J-Glove in enhancing hand function post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of an electromyographically driven hand orthosis for training after stroke. Ochoa, JM., Listenberger, M., Kamper, DG., et al.[2016]

The ArmAssist-2.0 hand module has been redesigned with adjustable linkages and new joint locations to better mimic the biomechanics of the human hand, enhancing its functionality for stroke rehabilitation.

The device features a torque profile that is more aligned with patient needs, providing consistent assistance for hand opening, which is crucial for effective recovery from motor impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design parameters and torque profile modification of a spring-assisted hand-opening exoskeleton module. Butler, NR., Goodwin, SA., Perry, JC.[2018]

The study involved 10 chronic stroke patients, with 5 using a 3D-printed dynamic hand device (3D-DHD) alongside task-oriented training, showing significant improvements in manual dexterity and strength compared to a control group that only received task-oriented training.

The 3D-DHD effectively helped position stroke-affected hands for better functional opposition, enhancing the ability to perform advanced hand movements, which is crucial for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical Evaluation of Three-Dimensional Printed Dynamic Hand Device for Patients With Chronic Stroke. Huang, TY., Pan, LH., Yang, WW., et al.[2020]

The study developed a 3D-printed multifunctional hand device (3DP-MFHD) that addresses limitations of existing hand rehabilitation devices, allowing for multiple grasping motions and more natural hand postures.

In a 4-week home rehabilitation program with 6 participants, the 3DP-MFHD significantly improved hand grip force by 36.1%, lateral pinch force by 17.6%, and overall arm function by 54.1%, demonstrating its efficacy in enhancing hand rehabilitation for chronic stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Assessment of 3D-Printed Multifunction Assistive Hand Device for Chronic Stroke Patients. Chen, ZH., Yang, YL., Lin, KW., et al.[2022]

A novel robotic hand rehabilitation device designed for stroke patients was tested on 52 healthy adults, showing high comfort levels (mean score of 8.5/10) and consistent performance across different hand sizes.

The device demonstrated safety and reliability, with no significant differences in force measurements during repeated use, allowing it to progress to clinical trials for individuals recovering from stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Testing of Robotic Exoskeleton Hand Device for Stroke Rehabilitation. Alhamad, R., Seth, N., Abdullah, HA.[2023]

The RobHand robotic exoskeleton is a safe rehabilitation tool for stroke patients, with no significant adverse events reported during the training sessions, and users expressed high satisfaction with its comfort and professional support.

Despite the positive safety and satisfaction outcomes, the study found no statistically significant improvements in manual function after 16 training sessions, likely due to the chronic stage of the stroke in the participants, suggesting that future research should focus on earlier intervention in subacute patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hand rehabilitation based on the RobHand exoskeleton in stroke patients: A case series study. Barria, P., Riquelme, M., Reppich, H., et al.[2023]

The pediatric robotic hand orthosis (RHO) PEXO was successfully tailored to meet the specific needs of a 13-year-old child with hand impairment after a traumatic brain injury, leading to improved hand ability and increased acceptance of the device.

The child used the PEXO at home for an average of 76 minutes over three days, showing that with proper training and customization, a robotic orthosis can be feasibly integrated into daily activities without any reported safety issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Tailorable Robotic Hand Orthosis to Support Children with Neurological Hand Impairments: a Case Study in a Child's Home. Dittli, J., Goikoetxea-Sotelo, G., Lieber, J., et al.[2023]

The HandSOME II exoskeleton, designed for home use, enables movement across 15 degrees of freedom in the hand, which could significantly aid in rehabilitation for individuals with stroke.

An innovative activity tracking device using machine learning to monitor finger movements may enhance compliance and effectiveness of home-based therapy programs for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A tracking device for a wearable high-DOF passive hand exoskeleton. Casas, R., Martin, K., Sandison, M., et al.[2022]

The proposed assistive device for stroke survivors uses a single actuator for each finger, providing tailored flexion and extension assistance to help overcome hand weakness and incoordination caused by stroke-related impairments.

By decoding user intent from Electromyographic (EMG) signals, the device allows for customized control based on each individual's muscle activation capabilities, potentially improving their independence and engagement in daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Hand Exoskeleton for Stroke Survivors' Activities of Daily Life. Ghassemi, M., Kamper, DG.[2022]

The HandSOME II device, designed for stroke patients, significantly improved finger extension and range of motion in the index finger during initial testing with seven participants, indicating its potential effectiveness in enhancing hand function (P<0.05).

This lightweight, passive device enables users to perform various grip patterns necessary for daily activities, making it a valuable tool for home-based therapy programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hand rehabilitation after stroke using a wearable, high DOF, spring powered exoskeleton. Tianyao Chen, ., Lum, PS.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of a functional hand orthosis combined with electrical stimulation adjunct to arm-hand rehabilitation in subacute stroke patients with a severely to moderately affected hand function. [2020]

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

Use of an electromyographically driven hand orthosis for training after stroke. [2016]

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

Design parameters and torque profile modification of a spring-assisted hand-opening exoskeleton module. [2018]

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

Biomechanical Evaluation of Three-Dimensional Printed Dynamic Hand Device for Patients With Chronic Stroke. [2020]

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

Functional Assessment of 3D-Printed Multifunction Assistive Hand Device for Chronic Stroke Patients. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Initial Testing of Robotic Exoskeleton Hand Device for Stroke Rehabilitation. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Hand rehabilitation based on the RobHand exoskeleton in stroke patients: A case series study. [2023]

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

A Tailorable Robotic Hand Orthosis to Support Children with Neurological Hand Impairments: a Case Study in a Child's Home. [2023]

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

A tracking device for a wearable high-DOF passive hand exoskeleton. [2022]

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

A Hand Exoskeleton for Stroke Survivors' Activities of Daily Life. [2022]

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

Hand rehabilitation after stroke using a wearable, high DOF, spring powered exoskeleton. [2020]