Robotic Rehabilitation for Stroke
(Aim2&3 Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Maryland, Baltimore
Disqualifiers: Apraxia, Severe pain, Severe contracture, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Sensorimotor impairments following stroke often involve complex pathological changes across multiple joints and multiple degrees of freedom of the arm and hand, thereby rendering them difficult to diagnose and treat. The objective of this study is to evaluate multi-joint neuromechanical impairments in the arm and hand, then conduct impairment-specific treatment, and determine the effects of arm versus hand training and the effects of passive stretching before active movement training.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Hand robot therapy for stroke rehabilitation?
Research shows that robot-assisted hand therapy can help improve movement and function in the arms and hands of stroke patients. It is often as effective, or even more effective, than traditional therapy, especially when used early in the rehabilitation process.
12345Is robotic rehabilitation for stroke generally safe for humans?
Research on robotic rehabilitation devices, like the RobHand exoskeleton, shows they are generally safe for humans, with no significant adverse events reported, such as skin lesions or fatigue. Safety assessments of rehabilitation robots focus on preventing excessive forces on the body, and current studies suggest these devices are safe when used correctly.
678910How is the IntelliArm treatment different from other stroke rehabilitation treatments?
The IntelliArm treatment is unique because it uses a robotic device to assist with hand movements, allowing for more repetitions of specific tasks, which can lead to better motor and functional improvements in the upper limb compared to traditional therapies. This robot-assisted therapy can be personalized and used at home, making it a flexible option for stroke rehabilitation.
123411Eligibility Criteria
This trial is for individuals who had their first stroke 1-12 months ago, can sit for 3 hours, and have an arm and hand recovery stage rated between 2-4. It's not suitable for those with severe pain or contracture in the upper extremity, apraxia, low mental status scores, recent Botox in the arm, or involvement in other gait/limb studies.Inclusion Criteria
I have had one stroke, either from a clot or bleed.
My arm and hand recovery after stroke is rated between stages 2 to 4.
I had a stroke between 1 and 12 months ago.
Exclusion Criteria
I rate my shoulder pain as 7 or more out of 10.
I have severe stiffness in my arm that limits movement.
I have not had a Botox injection in my arm in the last 4 months.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo robot-aided rehabilitation with either the IntelliArm or hand robot, involving passive stretching or movement followed by active therapy
8 weeks
Multiple sessions per week
Follow-up
Participants are monitored for changes in motor function and other outcomes post-treatment
2 months
Assessments at 2 weeks and 2 months post-treatment
Participant Groups
The study aims to assess and treat complex motor impairments of the arm and hand post-stroke. It will compare effects of different treatments: passive movement using a Hand robot or IntelliArm device versus passive stretching exercises on limb function recovery.
4Treatment groups
Experimental Treatment
Group I: The hand robot with passive stretchingExperimental Treatment2 Interventions
Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will complete up to 30 minutes of strong passive stretching, then followed by 45-60 minutes of active movement training with the hand robot.
Group II: The hand robot with passive movementExperimental Treatment2 Interventions
Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the hand robot for up to 30 minutes with gentle passive movement or little stretching, then followed by 45-60 minutes of active movement training with the hand robot.
Group III: IntelliArm with passive stretchingExperimental Treatment2 Interventions
Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will complete up to 30 minutes of strong passive stretching, then followed by 45-60 minutes of active movement training with the IntelliArm.
Group IV: IntelliArm with passive movementExperimental Treatment2 Interventions
Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the IntelliArm for up to 30 minutes with gentle passive movement or little stretching, then followed by 45-60 minutes of active movement training with the IntelliArm.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Maryland, BaltimoreBaltimore, MD
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Who Is Running the Clinical Trial?
University of Maryland, BaltimoreLead Sponsor
North Carolina State UniversityCollaborator
National Institute on Disability, Independent Living, and Rehabilitation ResearchCollaborator
References
[Hand robotic devices in neurorehabilitation: A systematic review on the feasibility and effectiveness of stroke rehabilitation]. [2023]Robot-assisted therapy is a relatively new intervention, increasingly used in the rehabilitation treatment of stroke patients. It allows to increase the number of repetitions in the performance of specific tasks movements. For this review, a search was carried out between August and October 2021 in the PubMed, Web of Science, Scopus, Cochrane, PEDro and OTseeker databases, selecting a total of six randomized controlled trials where robot-assisted hand therapy was used in stroke rehabilitation. Studies agree that robot-assisted hand therapy has benefits in all phases of stroke rehabilitation that translate into motor and functional improvements of the upper limb and improvements in hemispatial neglect.
Effectiveness of upper-limb robotic-assisted therapy in the early rehabilitation phase after stroke: A single-blind, randomised, controlled trial. [2020]Upper-limb robotic-assisted therapy (RAT) is promising for stroke rehabilitation, particularly in the early phase. When RAT is provided as partial substitution of conventional therapy, it is expected to be at least as effective or might be more effective than conventional therapy. Assessments have usually been restricted to the first 2 domains of the International classification of functioning, disability and health (ICF).
Robotic devices and brain-machine interfaces for hand rehabilitation post-stroke. [2018]To review the state of the art of robotic-aided hand physiotherapy for post-stroke rehabilitation, including the use of brain-machine interfaces. Each patient has a unique clinical history and, in response to personalized treatment needs, research into individualized and at-home treatment options has expanded rapidly in recent years. This has resulted in the development of many devices and design strategies for use in stroke rehabilitation.
Efficacy of Short-Term Robot-Assisted Rehabilitation in Patients With Hand Paralysis After Stroke: A Randomized Clinical Trial. [2019]We evaluated the effectiveness of robot-assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT) on stroke patients with hand paralysis.
Individual finger synchronized robot-assisted hand rehabilitation in subacute to chronic stroke: a prospective randomized clinical trial of efficacy. [2016]To evaluate individual finger synchronized robot-assisted hand rehabilitation in stroke patients.
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.
Electronic training devices for hand rehabilitation. [2012]Several new electronic hand rehabilitation devices are shown. These devices, which can be assembled locally with minimal funds, are excellent information feedback devices that can be used effectively in hand rehabilitation. Electrogoniometers may be used for hand and wrist range-of-motion feedback. In addition, various pressure sensitive devices are illustrated and the way in which these devices may be used in hand rehabilitation are portrayed.
Safety Assessment of Rehabilitation Robots: A Review Identifying Safety Skills and Current Knowledge Gaps. [2021]The assessment of rehabilitation robot safety is a vital aspect of the development process, which is often experienced as difficult. There are gaps in best practices and knowledge to ensure safe usage of rehabilitation robots. Currently, safety is commonly assessed by monitoring adverse events occurrence. The aim of this article is to explore how safety of rehabilitation robots can be assessed early in the development phase, before they are used with patients. We are suggesting a uniform approach for safety validation of robots closely interacting with humans, based on safety skills and validation protocols. Safety skills are an abstract representation of the ability of a robot to reduce a specific risk or deal with a specific hazard. They can be implemented in various ways, depending on the application requirements, which enables the use of a single safety skill across a wide range of applications and domains. Safety validation protocols have been developed that correspond to these skills and consider domain-specific conditions. This gives robot users and developers concise testing procedures to prove the mechanical safety of their robotic system, even when the applications are in domains with a lack of standards and best practices such as the healthcare domain. Based on knowledge about adverse events occurring in rehabilitation robot use, we identified multi-directional excessive forces on the soft tissue level and musculoskeletal level as most relevant hazards for rehabilitation robots and related them to four safety skills, providing a concrete starting point for safety assessment of rehabilitation robots. We further identified a number of gaps which need to be addressed in the future to pave the way for more comprehensive guidelines for rehabilitation robot safety assessments. Predominantly, besides new developments of safety by design features, there is a strong need for reliable measurement methods as well as acceptable limit values for human-robot interaction forces both on skin and joint level.
Testing the Limit Range of Motion Safety Function of Upper Limb Rehabilitation Robots with an Anthropometrically Adjustable and Sensorized Dummy Limb. [2022]Arm type or exoskeleton type rehabilitation robots move the patient's upper limb through one or more, either free or restrained connection points. The rehabilitation robot is unsafe if it moves the patient's upper limb beyond the limits of the anatomical joint ranges. A validation toolkit was developed to assess the risks of "limit anatomical joint range of movement" and "limit anatomical joint overreaching" during the regular operation of a rehabilitation robot. The validation toolkit includes an anthropometrically adjustable and sensorised dummy limb attached to the RACA (rehabilitation, assessment, compensation, or alleviation) rehabilitation robot; and a software tool for off-line risk assessment and reporting.
A Novel Clinical-Driven Design for Robotic Hand Rehabilitation: Combining Sensory Training, Effortless Setup, and Large Range of Motion in a Palmar Device. [2023]Neurorehabilitation research suggests that not only high training intensity, but also somatosensory information plays a fundamental role in the recovery of stroke patients. Yet, there is currently a lack of easy-to-use robotic solutions for sensorimotor hand rehabilitation. We addressed this shortcoming by developing a novel clinical-driven robotic hand rehabilitation device, which is capable of fine haptic rendering, and that supports physiological full flexion/extension of the fingers while offering an effortless setup. Our palmar design, based on a parallelogram coupled to a principal revolute joint, introduces the following novelties: (1) While allowing for an effortless installation of the user's hand, it offers large range of motion of the fingers (full extension to 180° flexion). (2) The kinematic design ensures that all fingers are supported through the full range of motion and that the little finger does not lose contact with the finger support in extension. (3) We took into consideration that a handle is usually comfortably grasped such that its longitudinal axis runs obliquely from the metacarpophalangeal joint of the index finger to the base of the hypothenar eminence. (4) The fingertip path was optimized to guarantee physiologically correct finger movements for a large variety of hand sizes. Moreover, the device possesses a high mechanical transparency, which was achieved using a backdrivable cable transmission. The transparency was further improved with the implementation of friction and gravity compensation. In a test with six healthy participants, the root mean square of the human-robot interaction force was found to remain as low as 1.37 N in a dynamic task. With its clinical-driven design and easy-to-use setup, our robotic device for hand sensorimotor rehabilitation has the potential for high clinical acceptance, applicability and effectiveness.
Upper and lower extremity robotic devices for rehabilitation and for studying motor control. [2022]The successful motor rehabilitation of stroke, traumatic brain-injured and spinal cord-injured patients requires an intensive and task-specific therapy approach. Budget constraints limit a hand-to-hand therapy approach, so that intelligent machines may offer a solution to promote motor recovery and obtain a better understanding of motor control. This new field of automated or robot-assisted motor rehabilitation has emerged since the 1990s.