Finger Movement Training for Stroke
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: North Carolina State University
Disqualifiers: Rigid contractures, Hemispatial neglect, Excessive pain
No Placebo Group
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.
12345Is 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.
23678How 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.
59101112Eligibility 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.
+1 more
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.
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Functional electrical stimulation (FES) + AVK groupExperimental Treatment1 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 GroupActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Hand Rehabilitation LabRaleigh, NC
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Who Is Running the Clinical Trial?
North Carolina State UniversityLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
Use of a novel robotic interface to study finger motor control. [2016]Stroke is the leading cause of permanent adult disability in the U.S., frequently resulting in chronic motor impairments. Rehabilitation of the upper limb, particularly the hand, is especially important as arm and hand deficits post-stroke limit the performance of activities of daily living and, subsequently, functional independence. Hand rehabilitation is challenging due to the complexity of motor control of the hand. New instrumentation is needed to facilitate examination of the hand. Thus, a novel actuated exoskeleton for the index finger, the FingerBot, was developed to permit the study of finger kinetics and kinematics under a variety of conditions. Two such novel environments, one applying a spring-like extension torque proportional to angular displacement at each finger joint and another applying a constant extension torque at each joint, were compared in 10 stroke survivors with the FingerBot. Subjects attempted to reach targets located throughout the finger workspace. The constant extension torque assistance resulted in a greater workspace area (p
Pilot test of dosage effects in HEXORR II for robotic hand movement therapy in individuals with chronic stroke. [2022]Impaired use of the hand in functional tasks remains difficult to overcome in many individuals after a stroke. This often leads to compensation strategies using the less-affected limb, which allows for independence in some aspects of daily activities. However, recovery of hand function remains an important therapeutic goal of many individuals, and is often resistant to conventional therapies. In prior work, we developed HEXORR I, a robotic device that allows practice of finger and thumb movements with robotic assistance. In this study, we describe modifications to the device, now called HEXORR II, and a clinical trial in individuals with chronic stroke. Fifteen individuals with a diagnosis of chronic stroke were randomized to 12 or 24 sessions of robotic therapy. The sessions involved playing several video games using thumb and finger movement. The robot applied assistance to extension movement that was adapted based on task performance. Clinical and motion capture evaluations were performed before and after training and again at a 6-month followup. Fourteen individuals completed the protocol. Fugl-Meyer scores improved significantly at the 6 month time point compared to baseline, indicating reductions in upper extremity impairment. Flexor hypertonia (Modified Ashworth Scale) also decreased significantly due to the intervention. Motion capture found increased finger range of motion and extension ability after the intervention that continued to improve during the followup period. However, there was no change in a functional measure (Action Research Arm Test). At the followup, the high dose group had significant gains in hand displacement during a forward reach task. There were no other significant differences between groups. Future work with HEXORR II should focus on integrating it with functional task practice and incorporating grip and squeezing tasks.
Home-Based Therapy After Stroke Using the Hand Spring Operated Movement Enhancer (HandSOME II). [2023]We have developed a passive and lightweight wearable hand exoskeleton (HandSOME II) that improves range of motion and functional task practice in laboratory testing. For this longitudinal study, we recruited 15 individuals with chronic stroke and asked them to use the device at home for 1.5 h per weekday for 8 weeks. Subjects visited the clinic once per week to report progress and troubleshoot problems. Subjects were then given the HandSOME II for the next 3 months, and asked to continue to use it, but without any scheduled contact with the project team. Clinical evaluations and biomechanical testing was performed before and after the 8 week intervention and at the 3 month followup. EEG measures were taken before and after the 8 weeks of training to examine any recovery associated brain reorganization. Ten subjects completed the study. After 8 weeks of training, functional ability (Action Research Arm Test), flexor tone (Modified Ashworth Test), and real world use of the impaired limb (Motor Activity Log) improved significantly (p < 0.05). Gains in real world use were retained at the 3-month followup (p = 0.005). At both post-training and followup time points, biomechanical testing found significant gains in finger ROM and hand displacement in a reaching task (p < 0.05). Baseline functional connectivity correlated with gains in motor function, while changes in EEG functional connectivity paralleled changes in motor recovery. HandSOME II is a low-cost, home-based intervention that elicits brain plasticity and can improve functional motor outcomes in the chronic stroke population.
Walking faster and farther with a soft robotic exosuit: Implications for post-stroke gait assistance and rehabilitation. [2022]Soft robotic exosuits can improve the mechanics and energetics of walking after stroke. Building on this prior work, we evaluated the effects of the first prototype of a portable soft robotic exosuit.
Soft Robotic Bilateral Hand Rehabilitation System for Fine Motor Learning. [2020]This paper presents the development of a pneumatically actuated soft robotic based bilateral therapy system for hand rehabilitation in post-stroke patients. The goal is to use a healthy hand to guide the motion of the paretic hand using a sensorized glove and a robotic exoskeleton, respectively. The sensorized glove tracks the motion of the healthy hand and provides inputs for the soft robotic hand exoskeleton to apply mimicking motion to the paretic hand. Two control algorithms, PD flow-based and adaptive PD pressure-based position controls, were developed and tested. Initial tests confirmed the ability of the systems to apply bilateral therapy. Furthermore, the adaptive pressure-based controller showed better performance with overall error reduced by 25.8% with respect to the flow-based controller. Future studies will include feasibility and performance of the system for applying therapy to post-stroke patients.
Novel knit fabric rehabilitation equipment for finger impairment. [2022][Purpose] Intensive training can at least partially improve finger movement dysfunction observed after stroke or any neurodegenerative disease. Wearable equipment can significantly improve patients' quality of life. However, long-term use of conventional training gloves containing metal can injure joints. In this study, we investigated the safety and efficacy of a novel, metal-free, wearable strength-building device. [Participants and Methods] We enrolled 20 healthy participants in whom we measured grip and pinch strength before and while the equipment was worn. Additionally, we investigated the adverse effects and discomfort experienced while participants wore the equipment. [Results] The grip strength was reduced by approximately 20% while participants wore the equipment. We did not observe any serious adverse events. [Conclusion] The knitting equipment described in this study resists movements associated with gripping the hand and acts on all fingers, and may be useful for rehabilitation to improve finger function during routine activities.
Initial Testing of Robotic Exoskeleton Hand Device for Stroke Rehabilitation. [2023]The preliminary test results of a novel robotic hand rehabilitation device aimed at treatment for the loss of motor abilities in the fingers and thumb due to stroke are presented. This device has been developed in collaboration with physiotherapists who regularly treat individuals who have suffered from a stroke. The device was tested on healthy adults to ensure comfort, user accessibility, and repeatability for various hand sizes in preparation for obtaining permission from regulatory bodies and implementing the design in a full clinical trial. Trials were conducted with 52 healthy individuals ranging in age from 19 to 93 with an average age of 58. A comfort survey and force data ANOVA were performed to measure hand motions and ensure the repeatability and accessibility of the system. Readings from the force sensor (p < 0.05) showed no significant difference between repetitions for each participant. All subjects considered the device comfortable. The device scored a mean comfort value of 8.5/10 on all comfort surveys and received the approval of all physiotherapists involved. The device has satisfied all design specifications, and the positive results of the participants suggest that it can be considered safe and reliable. It can therefore be moved forward for clinical trials with post-stroke users.
Hand rehabilitation based on the RobHand exoskeleton in stroke patients: A case series study. [2023]Introduction: The RobHand (Robot for Hand Rehabilitation) is a robotic neuromotor rehabilitation exoskeleton that assists in performing flexion and extension movements of the fingers. The present case study assesses changes in manual function and hand muscle strength of four selected stroke patients after completion of an established training program. In addition, safety and user satisfaction are also evaluated. Methods: The training program consisted of 16 sessions; two 60-minute training sessions per week for eight consecutive weeks. During each session, patients moved through six consecutive rehabilitation stages using the RobHand. Manual function assessments were applied before and after the training program and safety tests were carried out after each session. A user evaluation questionnaire was filled out after each patient completed the program. Results: The safety test showed the absence of significant adverse events, such as skin lesions or fatigue. An average score of 4 out of 5 was obtained on the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 Scale. Users were very satisfied with the weight, comfort, and quality of professional services. A Kruskal-Wallis test revealed that there were not statistically significant changes in the manual function tests between the beginning and the end of the training program. Discussion: It can be concluded that the RobHand is a safe rehabilitation technology and users were satisfied with the system. No statistically significant differences in manual function were found. This could be due to the high influence of the stroke stage on motor recovery since the study was performed with chronic patients. Hence, future studies should evaluate the rehabilitation effectiveness of the repetitive use of the RobHand exoskeleton on subacute patients. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT05598892?id=NCT05598892&draw=2&rank=1, identifier NCT05598892.
A pneumatic glove and immersive virtual reality environment for hand rehabilitative training after stroke. [2017]While a number of devices have recently been developed to facilitate hand rehabilitation after stroke, most place some restrictions on movement of the digits or arm. Thus, a novel glove was developed which can provide independent extension assistance to each digit while still allowing full arm movement. This pneumatic glove, the PneuGlove, can be used for training grasp-and-release movements either with real objects or with virtual objects in a virtual reality environment. Two groups of stroke survivors, with seven subjects in each group, completed a six-week rehabilitation training protocol, consisting of three 1-h sessions held each week. One group wore the PneuGlove during training, performed both within a novel virtual reality environment and outside of it with physical objects, while the other group completed the same training without the device. Across subjects, significant improvements were observed in the Fugl-Meyer Assessment for the upper extremity (p
A soft neuroprosthetic hand providing simultaneous myoelectric control and tactile feedback. [2023]Neuroprosthetic hands are typically heavy (over 400 g) and expensive (more than US$10,000), and lack the compliance and tactile feedback of human hands. Here, we report the design, fabrication and performance of a soft, low-cost and lightweight (292 g) neuroprosthetic hand that provides simultaneous myoelectric control and tactile feedback. The neuroprosthesis has six active degrees of freedom under pneumatic actuation, can be controlled through the input from four electromyography sensors that measure surface signals from residual forearm muscles, and integrates five elastomeric capacitive sensors on the fingertips to measure touch pressure so as to enable tactile feedback by eliciting electrical stimulation on the skin of the residual limb. In a set of standardized tests performed by two individuals with transradial amputations, we show that the soft neuroprosthetic hand outperforms a conventional rigid neuroprosthetic hand in speed and dexterity. We also show that one individual with a transradial amputation wearing the soft neuroprosthetic hand can regain primitive touch sensation and real-time closed-loop control.
A Preliminary Study to Design and Evaluate Pneumatically Controlled Soft Robotic Actuators for a Repetitive Hand Rehabilitation Task. [2022]A stroke is an infarction in the cortical region of the brain that often leads to isolated hand paresis. This common side effect renders individuals compromised in their ability to actively flex or extend the fingers of the affected hand. While there are currently published soft robotic glove designs, this article proposed a unique design that allows users to self-actuate their therapy due to the ability to re-extend the hand using a layer of resistive flexible steel. The results showed a consistently achieved average peak of 75° or greater for each finger while the subjects' hands were at rest during multiple trials of pneumatic assisted flexion. During passive assisted testing, human subject testing on 10 participants showed that these participants were able to accomplish 80.75% of their normal active finger flexion range with the steel-layer-lined pneumatic glove and 87.07% with the unlined pneumatic glove on average when neglecting outliers. An addition of the steel layer lowered the blocked tip force by an average of 18.13% for all five fingers. These data show strong evidence that this glove would be appropriate to advance to human subject testing on those who do have post stroke hand impairments.
High Compliance Pneumatic Actuators to Promote Finger Extension in Stroke Survivors. [2021]Compliant pneumatic systems are well suited for wearable robotic applications. The actuators are lightweight, conformable to irregular shapes, and tolerant of uncontrolled degrees of freedom. These attributes are especially desirable for hand exoskeletons given their space and mass constraints. Creating active digit extension with these exoskeletons is especially critical for clinical populations such as stroke survivors who often have great difficulty opening their paretic hand. To achieve active digit extension with a soft actuator, we have created pneumatic chambers that lie along the palmar surface of the digits. These chambers can directly extend the digits when pressurized. We present a characterization of the extension force and passive flexion resistance generated by these pneumatic chambers across a range of joint angles as a function of cross-sectional shape, dimension, and wall thickness. The chambers were fabricated out of DragonSkin 20 using custom molds and were tested on a custom jig. Extension forces created at the end of the chamber (where fingertip contact would occur) exceeded 3.00 N at relatively low pressure (48.3 kPa). A rectangular cross-section generated higher extension force than a semi-obround cross-sectional shape. Extension force was significantly higher (p