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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve hand function in people recovering from a stroke. It tests a new treatment that combines electrical nerve stimulation with a soft, glove-like device (Actuated Hand Exoskeleton) to assist finger and thumb movement. The study compares this method with traditional therapy to determine which more effectively restores hand control. It suits stroke survivors with mild to moderate hand issues who can see shapes on a screen. Participants should be between 2 to 18 months into their stroke recovery. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could enhance recovery outcomes.

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 prior data suggests that this intervention is safe for stroke rehabilitation?

Research shows that both parts of the trial treatment—functional electrical stimulation (FES) and the hand exoskeleton—are generally safe. Studies have found that FES is often well-tolerated and can improve arm and hand function after a stroke. A review of several studies showed that FES aids in upper limb recovery with few side effects, indicating its general safety for stroke recovery.

For the hand exoskeleton, research has examined its design and use in hand rehabilitation. Studies on similar devices have found them reliable and helpful in assisting hand movements. These devices are designed to be gentle and supportive, reducing the risk of harm.

Overall, both FES and the hand exoskeleton have demonstrated promising safety in previous research. This combination aims to improve hand function with minimal risk. Participants in this trial can feel reassured by the existing evidence of safety for these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional stroke rehabilitation therapies that often focus on repetitive exercises and passive movements, the actuated hand exoskeleton in this trial takes a more interactive approach. This treatment combines functional electrical stimulation (FES) with an AVK system that challenges users through engaging activities like playing songs on a digital interface. By using targeted electrical impulses to stimulate finger movements and resist unwanted motion with the PneuGlove, this method aims to retrain the brain in a more dynamic and enjoyable way. Researchers are excited because this approach could lead to better engagement and potentially faster, more effective recovery of hand function in stroke patients.

What evidence suggests that this trial's treatments could be effective for stroke rehabilitation?

Research has shown that an air-powered hand exoskeleton, which participants in this trial may receive, can improve hand function after a stroke. Studies have found that this soft robotic device assists with hand movements and supports therapy exercises, such as bending and straightening the fingers. It helps stroke survivors practice essential hand movements, potentially leading to better recovery. One study found that this technology improved hand control in individuals with long-term stroke conditions. Overall, evidence suggests that these robotic aids enhance rehabilitation for those recovering hand function after a stroke. Meanwhile, another group in this trial will receive occupational therapy, focusing on active task practice and object manipulation to improve hand dexterity. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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]

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]

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 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5688261/

Hand Rehabilitation Robotics on Poststroke Motor Recovery The recovery of hand function is one of the most challenging topics in stroke rehabilitation. Although the robot-assisted therapy has got some good results ...

2. researchgate.net researchgate.net/publication/380507400_Pneumatically_Actuated_Soft_Robotic_Hand_and_Wrist_Exoskeleton_for_Motion_Assistance_in_Rehabilitation

(PDF) Pneumatically Actuated Soft Robotic Hand and Wrist ... The results showed the potential of the exoskeleton to provide flexion/extension rehabilitation exercises and task-oriented rehabilitation ...

3. mdpi.com mdpi.com/2076-0825/13/5/180

Pneumatically Actuated Soft Robotic Hand and Wrist ... This paper presents a pneumatically actuated soft robotic exoskeleton designed to provide coordinated assistive motion to the hand and wrist joints.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1052305721002159

Effects of a Soft Robotic Hand for Hand Rehabilitation in ... This research has shown the efficacy of soft robotic hand with flexion and extension assistive torque in chronic stroke rehabilitation.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1155/2024/5815358

Soft Robotic Hand Exoskeleton with Enhanced PneuNet ... This study demonstrates the potential of soft actuator technology in rehabilitation, presenting new possibilities for hand trauma recovery.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10610659/

Development and Testing of a Soft Exoskeleton Robotic Hand ... This work aimed to design, build, and verify a pneumatic hand training device for its eventual use in post-stroke rehabilitation.

7. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-024-01444-4

Soft pneumatic actuators for pushing fingers into extension The hand exoskeleton created with the rectangular chambers enabled rapid movement, with a cycle time of 1.1 s for voluntary flexion followed by ...