Device-Assisted ADL Practice for Stroke Recovery
Palo Alto (17 mi)Overseen byJun Yao, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Northwestern University
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial investigates the use of a special device called ReIn-Hand to help stroke survivors practice everyday tasks. The device assists with arm and hand movements, making it easier for participants to perform these tasks. The goal is to improve the functional use of their affected arm and hand.
What data supports the idea that Device-Assisted ADL Practice for Stroke Recovery is an effective treatment?The available research shows that using robotic devices for upper limb rehabilitation after a stroke can improve arm movement ability. One study found that robot-assisted movement training helps improve arm movement in both early and later stages of stroke recovery. Another study suggests that robot-assisted therapy can increase the amount of practice stroke survivors get, which is important for recovery. Although some findings are not conclusive due to small sample sizes, there is optimism that robotic forces, when combined with movement practice, can offer additional benefits. Overall, these studies indicate that Device-Assisted ADL Practice can be an effective treatment for stroke recovery.367811
Do I need to stop my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you have had botulinum toxin or similar injections in the last 6 months, you may not be eligible.
Is ReIn-Hand, Robot a promising treatment for stroke recovery?Yes, ReIn-Hand, Robot is a promising treatment for stroke recovery. It helps improve arm and hand movement by using robotic devices to assist with exercises. These devices can enhance motor abilities and reduce disability by providing targeted and interactive training, which is shown to be effective in improving outcomes for stroke patients.12359
What safety data exists for device-assisted ADL practice in stroke recovery?The RobHand exoskeleton study reported no significant adverse events, such as skin lesions or fatigue, indicating it is a safe rehabilitation technology. Users were satisfied with the device, scoring an average of 4 out of 5 on the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 Scale. Other studies on similar devices, like the HEXORR and HandSOME, focus on feasibility and potential benefits but do not provide specific safety data. Overall, existing data suggests these devices are safe for use in stroke rehabilitation.3461012
Eligibility Criteria
This trial is for individuals aged 21-80 who have had a moderate to severe stroke, resulting in significant arm weakness but with some ability to move. They must be able to sit for an hour, have a certain level of cognitive function (MoCA score >=23), and not be receiving other physical rehabilitation. Exclusions include recent seizures, severe sensory impairment in the arm, prior injections affecting muscle control, other neurological disorders or serious medical conditions.Inclusion Criteria
My skin is healthy on the arm affected by my stroke.
I have completed all my physical rehabilitation.
I can open my hand at least 4 cm wide with help from a device and therapist.
I understand and can agree to the study's procedures and risks.
I have weakness on one side of my body, affecting my arm but can still move it a little.
My cognitive function score is 23 or higher.
I am between 21 and 80 years old.
I can lift my arm and straighten my elbow somewhat against gravity.
Exclusion Criteria
I have a tumor in my brainstem or cerebellum.
I experience significant pain in my arms or back, rating it 5 or more out of 10.
I have severe stiffness in my elbow, wrist, and fingers.
I cannot lift my arm sideways or upwards to a right angle.
I can attend sessions 3 times a week for 8 weeks and all evaluations.
I have a history of a neurological disorder, but not stroke.
I had arm or hand movement problems before my stroke.
I have weakness or numbness in the limb not affected by my condition.
I do not have severe health issues like heart problems or uncontrolled high blood pressure.
I have had an amputation above the wrist.
I have had a seizure in the past 6 months.
Treatment Details
The study tests whether using a device called ReIn-Hand alongside robot assistance can help improve the use of arms/hands during daily activities after suffering from a stroke. It measures changes in motor skills and brain adaptability post-intervention.
2Treatment groups
Experimental Treatment
Active Control
Group I: ReIn-hand and robotExperimental Treatment2 Interventions
The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn-hand to open their paretic hand and of robot to reduce the shoulder load.
Group II: ReIn-HandActive Control1 Intervention
The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn-hand to open their paretic hand.
Find a clinic near you
Research locations nearbySelect from list below to view details:
645 N Michigan Ave, Suite 1100Chicago, IL
Northwestern University, Dept. of PTHMSChicago, IL
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
Robotics and other devices in the treatment of patients recovering from stroke. [2022]Stroke is the leading cause of permanent disability in the United States despite advances in prevention and novel interventional treatments. Randomized controlled studies have demonstrated the effectiveness of specialized post-stroke rehabilitation units, but administrative orders have severely limited the length of stay, so novel approaches to the treatment of recovery need to be tested in outpatients. Although the mechanisms of stroke recovery depend on multiple factors, a number of techniques that concentrate on enhanced exercise of the paralyzed limb have demonstrated effectiveness in reducing the motor impairment. For example, interactive robotic devices are new tools for therapists to deliver enhanced sensorimotor training for the paralyzed upper limb, which can potentially improve patient outcome and increase their productivity. New data support the idea that for some post-stroke patients and for some aspects of training-induced recovery, timing of the training may be less important than the quality and intensity of the training. The positive outcome that resulted in the interactive robotic trials contrasts with the failure to find a beneficial result in trials that used a noninteractive device that delivered continuous passive motion only. New pilot data from novel devices to move the wrist demonstrate benefit and suggest that successive improvement of the function of the arm progressing to the distal muscles may eventually lead to significant disability reduction. These data from robotic trials continue to contribute to the emerging scientific basis of neuro-rehabilitation.
Robotics and other devices in the treatment of patients recovering from stroke. [2019]Stroke is the leading cause of permanent disability in the United States despite advances in prevention and novel interventional treatments. Randomized controlled studies have demonstrated the effectiveness of specialized post-stroke rehabilitation units, but administrative orders have severely limited the length of stay, so novel approaches to the treatment of recovery need to be tested in outpatients. Although the mechanisms of stroke recovery depend on multiple factors, a number of techniques that concentrate on enhanced exercise of the paralyzed limb have demonstrated effectiveness in reducing the motor impairment. For example, interactive robotic devices are new tools for therapists to deliver enhanced sensorimotor training for the paralyzed upper limb, which can potentially improve patient outcome and increase patient productivity. New data support the idea that for some post-stroke patients and for some aspects of training-induced recovery, timing of the training may be less important than the quality and intensity of the training. The positive outcome that resulted in the interactive robotic trials contrasts with the failure to find a beneficial result in trials that used a noninteractive device that delivered continuous passive motion only. New pilot data from novel devices to move the wrist demonstrate benefit and suggest that successive improvement of the function of the arm progressing to the distal muscles may eventually lead to significant disability reduction. These data from robotic trials continue to contribute to the emerging scientific basis of neuro-rehabilitation.
Robot-assisted movement training for the stroke-impaired arm: Does it matter what the robot does? [2022]Robot-assisted movement training improves arm movement ability following acute and chronic stroke. Such training involves two interacting processes: the patient trying to move and the robot applying forces to the patient's arm. A fundamental principle of motor learning is that movement practice improves motor function; the role of applied robotic forces in improving motor function is still unclear. This article reviews our work addressing this question. Our pilot study using the Assisted Rehabilitation and Measurement (ARM) Guide, a linear robotic trainer, found that mechanically assisted reaching improved motor recovery similar to unassisted reaching practice. This finding is inconclusive because of the small sample size (n = 19), but suggest that future studies should carefully control the amount of voluntary movement practice delivered to justify the use of robotic forces. We are optimistic that robotic forces will ultimately show additional therapeutic benefits when coupled with movement practice. We justify this optimism here by comparing results from the ARM Guide and the Mirror Image Movement Enabler robotic trainer. This comparison suggests that requiring a patient to generate specific patterns of force before allowing movement is more effective than mechanically completing movements for the patient. We describe the engineering implementation of this "guided-force training" algorithm.
Hand spring operated movement enhancer (HandSOME) device for hand rehabilitation after stroke. [2020]Hand rehabilitation after stroke is essential for restoring functional independent lifestyles. After stroke, patients often have flexor hypertonia, making it difficult to open their hand for functional grasp. The development and initial testing of a passive hand rehabilitation device is discussed. The device, Hand Spring Operated Movement Enhancer (HandSOME), assists with opening the patient's hand using a series of bungee cords that apply extension torques to the finger joints that compensate for the flexor hypertonia. This results in significant increase in range of motion and functional use when wearing HandSOME, even in severely impaired subjects. Device design, calibration, and range of motion are described as well as functional and usability testing with stroke subjects.
Robot-assisted exercise for hand weakness after stroke: a pilot study. [2016]Upper-limb paresis is a major source of disability in stroke survivors, and robotic device-aided exercise therapy is a promising approach to enhance motor abilities. Few robotic devices have been available to provide therapy to the fingers and hand. This study was designed to test a new robotic device for hand rehabilitation in stroke survivors.
Clinical effects of using HEXORR (Hand Exoskeleton Rehabilitation Robot) for movement therapy in stroke rehabilitation. [2016]The goals of this pilot study were to quantify the clinical benefits of using the Hand Exoskeleton Rehabilitation Robot for hand rehabilitation after stroke and to determine the population best served by this intervention.
Accelerometry measuring the outcome of robot-supported upper limb training in chronic stroke: a randomized controlled trial. [2021]This study aims to assess the extent to which accelerometers can be used to determine the effect of robot-supported task-oriented arm-hand training, relative to task-oriented arm-hand training alone, on the actual amount of arm-hand use of chronic stroke patients in their home situation.
Repetitions, duration and intensity of upper limb practice following the implementation of robot assisted therapy with sub-acute stroke survivors: an observational study. [2022]Robot assisted upper limb (UL) therapy has been identified as an intervention with the potential to help improve the amount of practice performed by stroke survivors.
Robot-Assisted Training for Upper Limb in Stroke (ROBOTAS): An Observational, Multicenter Study to Identify Determinants of Efficacy. [2021]The loss of arm function is a common and disabling outcome after stroke. Robot-assisted upper limb (UL) training may improve outcomes. The aim of this study was to explore the effect of robot-assisted training using end-effector and exoskeleton robots on UL function following a stroke in real-life clinical practice.
Feasibility and Potential Effects of Robot-Assisted Passive Range of Motion Training in Combination with Conventional Rehabilitation on Hand Function in Patients with Chronic Stroke. [2022]To assess the effects of exoskeleton robot-assisted passive range of motion for induction training in combination with conventional hand rehabilitation in patients with chronic stroke.
Experiences of patients who had a stroke and rehabilitation professionals with upper limb rehabilitation robots: a qualitative systematic review protocol. [2022]Emerging evidence suggests that robotic devices for upper limb rehabilitation after a stroke may improve upper limb function. For robotic upper limb rehabilitation in stroke to be successful, patients' experiences and those of the rehabilitation professionals must be considered. Therefore, this review aims to synthesise the available evidence on experiences of patients after a stroke with rehabilitation robots for upper limb rehabilitation and the experiences of rehabilitation professionals with rehabilitation robots for upper limb stroke rehabilitation.
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.