Finger Movement Training for Stroke

Overseen By Mohammad Ghassemi, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: North Carolina State University

Disqualifiers: Rigid contractures, Hemispatial neglect, Excessive pain

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

Compensation: Varies

Number of Visits: 18

Duration: 5 weeks

36 Participants Needed

Trial Summary

What is the purpose of this trial?

Human development as a species has been strongly associated with the ability to dexterously manipulate objects and tools. Unfortunately, current therapy efforts typically fail to restore fine manual control after stroke. The goal of this study is to evaluate a new intervention that would combine targeted electrical stimulation of selected nerves with use a soft, pneumatically actuated hand exoskeleton to enhance repetitive practice of independent movements of the fingers and thumb in order to improve rehabilitation of hand function after stroke. The investigators will recruit stroke survivors in the subacute phase of recovery (2-18 months post-stroke). These participants will be involved in a 5-week intervention involving 15 training sessions. During these sessions, participants will train independent movement of the digits of the paretic hand. Evaluation of motor control of the paretic hand will occur prior to initiation of training, at the midpoint of the training period, after completion of training, and one month later.

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 treatment Actuated Hand Exoskeleton, Soft, Pneumatically Actuated Hand Exoskeleton, Occupational Therapy, OT, Occupational Rehabilitation, Ergotherapy for stroke patients?

Research shows that robotic hand movement therapy, like HEXORR II, can improve hand function and reduce muscle tightness in stroke patients. Additionally, home-based therapy with devices like HandSOME II has been shown to improve hand movement and real-world use of the impaired limb, with benefits lasting for months. ^{1 2 3 4 5}

Is finger movement training using hand exoskeletons safe for humans?

Research on various hand exoskeleton devices, including HandSOME II, HEXORR II, and RobHand, shows they are generally safe for use in humans, with no significant adverse events reported. Studies on healthy individuals and stroke patients found these devices comfortable and reliable, with no serious side effects. ^{2 3 6 7 8}

How is the Actuated Hand Exoskeleton treatment different from other treatments for stroke rehabilitation?

The Actuated Hand Exoskeleton is unique because it uses soft, pneumatically controlled actuators to help stroke survivors extend their fingers, allowing for more natural hand movements. Unlike other devices, it is lightweight and conforms to the hand's shape, providing independent assistance to each finger while allowing full arm movement, which is crucial for effective rehabilitation. ^{5 9 10 11 12}

Eligibility Criteria

This trial is for stroke survivors who are 2-6 months post-stroke, can consent, see shapes on a screen, and have moderate to mild hand impairment without severe pain or joint issues that would prevent movement.

Inclusion Criteria

Moderate to mild hand impairment, as determined by a rating of Stage 4-6 on the Stage of Hand section of the Chedoke-McMaster Stroke Assessment

I understand the details of the trial and can agree to participate.

I had a stroke once, between 2-9 months ago.

Exclusion Criteria

I have been diagnosed with hemispatial neglect.

I have stiff joints in my arms that limit their movement.

My shoulder pain in my weaker arm is not severe.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 5-week intervention involving 15 training sessions to improve hand function using targeted electrical stimulation and a hand exoskeleton

5 weeks

15 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations occurring at the midpoint, after completion, and one month later

4 weeks

3 visits (in-person)

Treatment Details

Interventions

• Actuated Hand Exoskeleton
• Occupational Therapy

Trial Overview The study tests a new therapy combining electrical nerve stimulation with a soft hand exoskeleton (AVK system) to improve finger movement. Participants will undergo 15 training sessions over 5 weeks with evaluations before, during, after training, and one month later.

Participant Groups

Group I: Functional electrical stimulation (FES) + AVK group Experimental Treatment 1 Intervention

This group will use the AVK system in combination with targeted FES to provide training of independent movement of each digit of the paretic hand. This training has two modes: Key Combination and Song. In the Key Combination mode, the subject will attempt to play the discrete key or key combinations specified on the computer screen to practice difficult movements and combinations. In the Song mode, sequential, rhythmic movements will be practiced as the participant is guided to play a series of keys, specified as falling keys, constituting five-note songs. Key Combination will be employed at the beginning and end of each training session to practice discrete movements that proved troubling during the current or previous session. Most of the session will be spent in the Song mode to emphasize the transitions from one movement to the next. In both modes the AVK system will trigger FES for the finger matching the desired key and signal the PneuGlove to resist movement of other digits.

Group II: OT Group Active Control 1 Intervention

An occupational therapist will provide therapy of matching duration to the OT subject group. This will consist of 10 minutes of stretching of the finger muscles, particularly of the extrinsic finger flexors. This stretching will be followed by two 20-minute sessions of therapy focused on active task practice, object manipulation, and individuated movement of the digits. The Canadian Occupational Performance Measure (COPM) will be administered to identify goals that incorporate dexterous use of the paretic hand. Part of each training session will be used to practice these tasks, while the remainder will be used to practice component skills. Active practice will be followed by a final 10 minutes of stretching of muscles of the digits.

Who Is Running the Clinical Trial?

North Carolina State University

Lead Sponsor

Trials

38

Recruited

50,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

The FingerBot, a novel actuated exoskeleton for the index finger, was tested on 10 stroke survivors and showed that constant extension torque assistance significantly increased the workspace area and active range of motion compared to spring-like assistance.

Using the FingerBot, participants demonstrated improved accuracy in reaching targets with constant extension torque assistance, highlighting its potential as a valuable tool for hand rehabilitation after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a novel robotic interface to study finger motor control. Cruz, EG., Kamper, DG.[2016]

In a clinical trial involving 15 individuals with chronic stroke, the modified robotic device HEXORR II significantly improved hand function, as evidenced by increased Fugl-Meyer scores and reduced flexor hypertonia after 12 or 24 therapy sessions.

While the robotic therapy enhanced finger movement and range of motion, it did not lead to improvements in overall functional tasks, suggesting that future studies should integrate the device with more practical hand activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot test of dosage effects in HEXORR II for robotic hand movement therapy in individuals with chronic stroke. Chen, J., Black, I., Nichols, D., et al.[2022]

The HandSOME II wearable hand exoskeleton significantly improved functional ability and real-world use of the impaired limb in 10 chronic stroke patients after 8 weeks of home use, with benefits retained at a 3-month follow-up.

The device not only enhanced physical performance, as shown by improved range of motion and hand displacement during tasks, but also appeared to promote brain reorganization, indicating its potential to support motor recovery through neuroplasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Therapy After Stroke Using the Hand Spring Operated Movement Enhancer (HandSOME II). Casas, R., Sandison, M., Nichols, D., et al.[2023]

The portable soft robotic exosuit, when powered on, significantly improved walking speed by a median of 0.14 m/s and increased walking distance by 32 meters in individuals post-stroke, demonstrating its efficacy in enhancing mobility.

The exosuit provides targeted assistance to the plantarflexors and dorsiflexors during walking, which helps reduce drop-foot and supports better walking mechanics for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Walking faster and farther with a soft robotic exosuit: Implications for post-stroke gait assistance and rehabilitation. Awad, LN., Kudzia, P., Revi, DA., et al.[2022]

A new soft robotic system has been developed to assist in hand rehabilitation for post-stroke patients by using a healthy hand to guide the movement of the affected hand, utilizing a sensorized glove and robotic exoskeleton.

Initial tests demonstrated that the adaptive pressure-based control algorithm outperformed the flow-based control, reducing overall error by 25.8%, indicating a promising approach for effective bilateral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soft Robotic Bilateral Hand Rehabilitation System for Fine Motor Learning. Haghshenas-Jaryani, M., Pande, C., Muthu Wijesundara, BJ.[2020]

The novel, metal-free wearable strength-building device was found to be safe for use, with no serious adverse events reported among the 20 healthy participants during the study.

While wearing the device, participants experienced a reduction in grip strength by about 20%, indicating that it effectively resists gripping movements, which may aid in rehabilitation for improving finger function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel knit fabric rehabilitation equipment for finger impairment. Mano, T., Fujimura, S., Amari, S., 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 PneuGlove, a novel pneumatic glove designed for stroke rehabilitation, allows independent extension of each finger while enabling full arm movement, facilitating training for grasp-and-release tasks in both real and virtual environments.

In a study with 14 stroke survivors over six weeks, significant improvements were noted in upper extremity function and strength for those using the PneuGlove, with greater mean improvements compared to the control group, although the differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pneumatic glove and immersive virtual reality environment for hand rehabilitative training after stroke. Connelly, L., Jia, Y., Toro, ML., et al.[2017]

The new soft neuroprosthetic hand is lightweight (292 g) and low-cost, providing myoelectric control and tactile feedback, which is a significant improvement over traditional heavy and expensive prosthetics.

In tests with individuals who have transradial amputations, this neuroprosthetic hand demonstrated better speed and dexterity compared to conventional rigid designs, allowing one user to regain a sense of touch and control in real-time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A soft neuroprosthetic hand providing simultaneous myoelectric control and tactile feedback. Gu, G., Zhang, N., Xu, H., et al.[2023]

A new soft robotic glove design allows stroke patients to self-actuate their therapy, achieving an average peak finger flexion of 75° or greater during pneumatic assisted flexion, which is crucial for rehabilitation.

In tests with 10 participants, the glove enabled users to achieve 80.75% of their normal finger flexion range, demonstrating its potential effectiveness for improving hand function in individuals with post-stroke impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Preliminary Study to Design and Evaluate Pneumatically Controlled Soft Robotic Actuators for a Repetitive Hand Rehabilitation Task. Rieger, C., Desai, J.[2022]

Pneumatic actuators designed for hand exoskeletons can effectively assist in finger extension, generating over 3.00 N of force at low pressure (48.3 kPa), which is crucial for helping stroke survivors open their hands.

The design of these actuators significantly impacts their performance; for instance, rectangular cross-sections and thicker walls produce greater extension forces, while passive flexion resistance remains consistent across different shapes and can be reduced with vacuum application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Compliance Pneumatic Actuators to Promote Finger Extension in Stroke Survivors. McCall, JV., Kamper, DG.[2021]

References

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

Use of a novel robotic interface to study finger motor control. [2016]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Pilot test of dosage effects in HEXORR II for robotic hand movement therapy in individuals with chronic stroke. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Home-Based Therapy After Stroke Using the Hand Spring Operated Movement Enhancer (HandSOME II). [2023]

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

Walking faster and farther with a soft robotic exosuit: Implications for post-stroke gait assistance and rehabilitation. [2022]

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

Soft Robotic Bilateral Hand Rehabilitation System for Fine Motor Learning. [2020]

6. Japan pubmed.ncbi.nlm.nih.gov

Novel knit fabric rehabilitation equipment for finger impairment. [2022]

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

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

A pneumatic glove and immersive virtual reality environment for hand rehabilitative training after stroke. [2017]

10. England pubmed.ncbi.nlm.nih.gov

A soft neuroprosthetic hand providing simultaneous myoelectric control and tactile feedback. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

A Preliminary Study to Design and Evaluate Pneumatically Controlled Soft Robotic Actuators for a Repetitive Hand Rehabilitation Task. [2022]

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

High Compliance Pneumatic Actuators to Promote Finger Extension in Stroke Survivors. [2021]