Posts Tagged Arm
[Abstract] Implementation and Evaluation of the Graded Repetitive Arm Supplementary Program (GRASP) for People With Stroke in a Real World Community Setting: Case Report
Objective: Exercise programs to improve upper extremity function following stroke in the community setting are needed as the length of hospital stay continues to decrease. However, little has been done to increase understanding of how to translate an evidence-based rehabilitation intervention to real-world programs. The purpose of this case report was to describe a process evaluation of the implementation of an evidence-based upper extremity rehabilitation intervention for stroke, the Graded Repetitive Arm Supplementary Program, in a community setting.
Methods (case description): A partnership between a nonprofit support organization and a local community center was established to deliver the program in the community. The Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework with mixed methods was used to evaluate the implementation.
Results: Reach: Twenty people were screened, 14 people met eligibility requirements, and 13 consented to participate. The program reached approximately 1.25% of the potential target population. Effectiveness: Participants with stroke demonstrated significant improvement in upper extremity function and quality of life as measured by the Fugl-Meyer Assessment for upper extremity, Action Research Arm Test, Rating of Everyday Arm-use in the Community and Home Scale, and Stroke Impact Scale. Adoption: Factors that facilitated program uptake were the well-planned implementation and the workplace coaching based on the audit results. Factors contributing to ongoing participation were the social support within the group environment and the instructor’s capability of engaging the group. Implementation: A partnership between a nonprofit organization and a local community center was successfully established. The program was implemented as intended as verified by a fidelity checklist. Participant adherence was high as confirmed by the average attendance and practice time. Maintenance: Both the partner organization and community center continued to offer the program.
Conclusion: The Graded Repetitive Arm Supplementary Program had good fidelity of the critical principles and core components and was effective in improving upper extremity function and quality of life.
Impact: This partnership model may serve as the first step for future larger-scale implementation and could be used to move other stroke rehabilitation interventions into community settings.
[Book Chapter] Rehabilitation Progress of Arm VR Game Based on Hand Trajectory – Abstract/References
Long-term disability can reduce someone’s performance in activities or jobs. Although stroke is not the leading cause of disability, 75% of stroke survivors have decreased activity caused by disability. Serious long-term disability can be treated by using active movements, repetitive tasks, and task-oriented or movement sequences. Evaluation and monitoring the rehabilitation after stroke is the most crucial element to prevent the injury and determine the next step rehabilitation. This study will discuss monitoring arm movement for virtual reality (VR) game rehabilitation based on the trajectory movements. Five participants have contributed to data collection during three sessions and five repetition. Their movement recorded by using Kinect Xbox One sensor with data sampling 10 Hz. The mean absolute trajectory error (ATE) and hand speed movement methods are used to analyze the arm movement during the VR game. Although this study uses healthy subjects, 80% of them have an improvement in the movements, and this condition is proven by the reduced ATE value in each session. Trajectory data provides useful information about arm movements during the rehabilitation of VR games, including movement errors, hand position errors and hand speed to reach targets. Moreover, the mean ATE and hand speed movement able to provide clear information about the development of hand movements in completing the game.
- 1.Johnson W, Onuma O, Owolabi M, Sachdev S (2016) Stroke: a global response is needed. Bull World Health Organ 94(9):633–708CrossRefGoogle Scholar
- 2.Clinic M (2017) Stroke rehabilitation: What to expect as you recover. https://www.mayoclinic.org/stroke-rehabilitation/art-20045172
- 3.Vicky G, Charles RL, Garland SJ (2012) Factors that influence muscle weakness following stroke and their clinical implications: a critical review. Physiother Can 64(4):415–426CrossRefGoogle Scholar
- 4.Trombetta M, Henrique PPB, Brum MR, Colussi EL, Marchi ACBD, Rieder R (2017) Motion Rehab AVE 3D: A VR-based exergame for post-stroke rehabilitation. Computer Methods and Programs in Biomedicine, pp. 15–20Google Scholar
- 5.Kultu M, Freeman CT, Hallewell E, Hughes A-M, Laila DS (2016) Upper-limb stroke rehabilitation using electrode-array based functional electrical stimulation with sensing and control innovationsGoogle Scholar
- 6.Krabben T, Molier BI, Houwink A, Rietman JS, Buurke JH, Prange GB (2011) Circle drawing as evaluative movement task in stroke rehabilitation: an explorative study. Neuroeng Rehabil 8(15):1–11Google Scholar
- 7.Caby B, Stamatakis J, Laloux P, Macq B, Vandermeeren Y (2011) Multi modal movement reconstruction for stroke rehabilitation and performance assessment. Multimod User Interface 4(3):119–127CrossRefGoogle Scholar
- 8.Zhang Z, Fang Q, Gu X (2015) Objective assessment of upper limb mobility for post-stroke rehabilitation. IEEE Trans Biomed Eng 63(4):859–868Google Scholar
- 9.Yeh SC, Lee SH, Wang JC, Chen S, Chen YT, Yang YY, Chen HR, Hung YP (2012) Virtual reality for post-stroke shoulder-arm motor rehabilitation: training system & assessment method. In: 14th International Conference on e-Health Networking, Applications and Services (Healthcom), pp 190–195 (2012)Google Scholar
- 10.Cahyadi BN, Khairunizam W, Ibrahim Z, Razlan ZM, Bakar SA, Mustafa WA, Majid SH (2018) Analysis of EMG based arm movement sequence using mean and median frequency. In: International Conference in Electronics, Electrical, Computer, Science and Informatics, Malang – IndonesiaGoogle Scholar
- 11.Cahyadi BN, Khairunizam W, Majid SH, Ibrahim Z, Bakar SA, Razlan ZM (2018) Investigation of Upper Limb Movement for VR based Post Stroke Rehabilitation Device. International Colloquium on Signal Processing & its Applications, Penang – MalaysiaGoogle Scholar
- 12.B. N. Cahyadi, W. Khairunizam, D. S. Sanny, Z. Ibrahim, L. H. Ling, S. A. Bakar, Z. M. Razlan and W. A. Mustafa: Arm Games for Virtual Reality Based Post-stroke Rehabilitation. Lecture Note in Mechanical Engineering, pp. 91–101 (2020).Google Scholar
- 13.Rasidah SN (2017) Design of Arm Movement Sequence for Virtual Reality-Based Upper Limb Management After-Stroke. University Malaysia Perlis, PerlisGoogle Scholar
- 14.Pedraza-Hueso M, Martín-Calzón S, Díaz-Pernas FJ, Martínez-Zarzuela M (2015) Rehabilitation using kinect-based game and virtual reality. Procedia Comput Sci 75:161–168CrossRefGoogle Scholar
- 15.Shahrbanian S, Ma X, Aghaei N, Korner-Bitensky N, Moshiri K, Simmonds MJ (2012) Use of virtual reality ( immersive vs non-immersive) for pain management in children and adults: a systematic review of evidence from randomized controlled trial. Exp Biol 2(5):408–1422Google Scholar
- 16.Sturm J, Engelhard N, Endres F, Burgard W, Cremers D (2012) A benchmark for the evaluation of RGB-D SLAM system. In: Intelligent Robots and Systems, VilamouraGoogle Scholar
- 17.Zhang C, Liu Y, Wang F, Xia Y, Zhang W (2018) VINS-MKF: a tightly-coupled multi-keyframe visual-inertial odometry for accurate and robust state estimation. Sensors 18(11):1–29CrossRefGoogle Scholar
- 18.Jhon, D (2011) Introduction to Coordinate Geometry. https://www.mathopenref.com/coorddist.html. Accessed 26 June 2019
Every year, more than 795,000 people in the United States have a stroke. Of these, approximately 80% lose arm function and as many as 50-60% of this population still experience problems six months later.
Traditionally, stroke patients try to regain motor function through physical rehabilitation, where patients re-learn pre-stroke skills, such as eating motions and grasping. However, most patients eventually plateau and stop improving over time.
Now, results of a clinical trial published in The Lancet gives patients new hope in their recovery.
Patients who received a novel treatment that combines vagus nerve stimulation (VNS) and rehabilitation showed improvement in upper body motor impairment compared to those who received sham (inactive form of) stimulation and rehabilitation. Considered a natural antenna to the brain, the vagus nerve runs from the chest and abdomen to the brainstem and regulates many of the body’s functions.
This is incredibly exciting news for everyone involved in stroke rehabilitation and functional restoration and represents a unique intersection between neurosurgery and neurorehabilitation. These study results are the first of their kind, and open up new possibilities for stroke patients, allowing them to reclaim more arm function even years after having a stroke.”
Charles Liu, MD, PhD, Study Lead Neurosurgeon and Director of Neurorestoration Center of Keck Medicine of University of South California
In this international, multi-center clinical trial, 53 participants with moderate to severe arm weakness nine months to 10 years post-stroke, received rehabilitation paired with VNS. Fifty-five patients within the same parameters received a sham stimulation. The trial was randomized and triple blind.
Those receiving the nerve stimulation had a wire inserted into their neck that wrapped around the vagus nerve. The wire was then connected to a pulse generator device implanted in the chest. Those receiving the sham received placebo implants.
After the surgical procedure, all patients received six weeks of in-clinic therapy, which included tasks such as reaching and grasping, simulated eating and opening and closing containers. After the in-clinic period, patients continued treatment with a course of daily home therapy.
When the two patient groups were compared, those receiving the nerve stimulation scored higher on several standardized measures of upper arm functionality.
“Not only were the results clinically meaningful, the fact that these patients were at least nine months post-stroke and in some instances years out, points to the possibility that meaningful improvements can be achieved even years after a stroke,” said Liu, who also serves as chief of innovation and research and chair of neurosurgery and orthopedics at Rancho Los Amigos National Rehabilitation Center.
The device is thought to work by triggering the release of brain neuromodulators – which regulate the body’s responses – to strengthen motor circuits in the brain associated with movement, enabling the brain to effectively relearn tasks. VNS is already used widely for the treatment of epilepsy and plays an increasing role in the treatment of severe depression.
“For too long, stroke patients have faced limited options for recovery,” said Liu. “This new treatment signifies a breakthrough that could be life-changing for many stroke patients and also represents an approach that will certainly be explored for many other functional restoration applications in the future.”
Journal reference: Dawson, J., et al. (2021) Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. The Lancet. doi.org/10.1016/S0140-6736(21)00475-X.
[Abstract + References] A Low-Cost Reaction Time Estimator-Based Hand and Foot Exercises for Stroke Rehabilitation – Conference paper
Stroke influences the fine motor skills and impair the person physically, mentally and economically. The physical and mental impairment may vary from slight to sever. In general, stroke influences the functionality of arm and feet and also the cognitive impairment. Stroke influences all the population equally across the globe, but it affects more to the developing nation like India. Very expensive stroke treatment and post-rehabilitation are the primary reason for more deaths in developing countries. Arduino-based low-cost reaction time estimator as an exercise tool is proposed in this study to calculate the time span for stroke rehabilitation. Proposed system is portable, and most importantly, it is low-cost device from which both hands and legs can be exercised based on the doctor’s instruction. This system would be very helpful in gaining the muscular strength of the people over time period.
- 1.Rosengren, A., Giang, K.W., Lappas, G., Jern, C., Torén, K., Björck, L.: Twenty-four-year trends in the incidence of ischemic stroke in Sweden from 1987 to 2010. Stroke 44(9), 2388–2393 (2013)CrossRefGoogle Scholar
- 2.Bonita, R., Beaglehole, R.: Stroke prevention in poor countries. Time for Action. Stroke 38, 2871–2872 (2007)Google Scholar
- 3.Pandian, J.D., Srikanth, V., Read, S.J., Thrift, A.G.: Poverty and stroke in India: a time to act. Stroke 38(11), 3063–3069 (2007)CrossRefGoogle Scholar
- 4.Mendis, S.: Stroke disability and rehabilitation of stroke: World Health Organization perspective. Int. J. Stroke 8(1), 3–4 (2013)CrossRefGoogle Scholar
- 5.Johnston, S.C., Mendis, S., Mathers, C.D.: Global variation in stroke burden and mortality: estimates from monitoring, surveillance, and modelling. Lancet Neurol. 8(4), 345–354 (2009)CrossRefGoogle Scholar
- 6.Banerjee, T.K., Roy, M.K., Bhoi, K.K.: Is stroke increasing in India–preventive measures that need to be implemented. J. Indian Med. Assoc. 103(3), 162–164 (2005)Google Scholar
- 7.Prasad, K.: Epidemology of cerebrovascular disorders in India. Recent concepts in stroke by Bansal BC (ed) Indian college of Physicians, New Delhi, 4–19 (1999)Google Scholar
- 8.Mishra, N.K., Patel, H., Hastak, S.M.: Comprehensive stroke care: an overview. JAPI 54, 36–41 (2006)Google Scholar
- 9.Luengo-Fernandez, R., Gray, A. M., Bull, L., Welch, S., Cuthbertson, F., Rothwell, P.M.: Quality of life after TIA and stroke Ten-year results of the Oxford Vascular Study. Neurology 10–1212 (2013)Google Scholar
- 10.Party, I.S.W.: National Clinical Guideline for Stroke, 4th edn. Royal College of Physicians, London (2012)Google Scholar
- 11.Care Quality Commission: Special Review. Supporting life after stroke: A review of services for people who have had a stroke and their carers. (2011)Google Scholar
- 12.National Audit Office: Progress in improving stroke care, Report on the findings from our modelling of stroke care provision (February 2010). NAO Report (HC 291 2009–2010)Google Scholar
Patients who received a novel treatment that combines vagus nerve stimulation (VNS) and rehabilitation showed improvement in upper body motor impairment compared to those who received a sham (inactive) form of stimulation and rehabilitation, according to results from a study published recently in The Lancet.
“This is incredibly exciting news for everyone involved in stroke rehabilitation and functional restoration and represents a unique intersection between neurosurgery and neurorehabilitation. These study results open up new possibilities for stroke patients, allowing them to reclaim more arm function even years after having a stroke.”
— Charles Liu, MD, PhD, the lead neurosurgeon of the study and director of the USC Neurorestoration Center of Keck Medicine of USC
VNS Versus Sham Stimulation
In this international, multi-center clinical trial, 53 participants with moderate to severe arm weakness 9 months to 10 years post-stroke received rehabilitation paired with VNS via the Vivistim Paired Vagus Nerve Stimulation System from MicroTransponder Inc, who sponsored the study.
Fifty-five patients within the same parameters received a sham stimulation. The trial was randomized and triple blind.
Those receiving the nerve stimulation had a wire inserted into their neck that wrapped around the vagus nerve. The wire was then connected to a pulse generator device implanted in the chest. Those receiving the sham received placebo implants.
After the surgical procedure, all patients received 6 weeks of in-clinic intense physical therapy, which included tasks such as reaching and grasping, simulated eating and opening and closing containers. After the in-clinic period, patients continued treatment with a course of daily home therapy.
When the two patient groups were compared, those receiving the nerve stimulation scored higher on several standardized measures of upper arm functionality, a media release from Keck Medicine of USC explains.
VNS Trial Data
In a separate release, MicroTransponder Inc shares the following data from the clinical trial:
The multi-center, double-blinded, randomized controlled trial enrolled 108 subjects that were up to 10 years post-stroke with moderate to severe upper extremity impairment.
Subjects in the study were randomized to either the Paired VNS group (intense physical therapy paired with active VNS) or Control group (intense physical therapy paired with sham VNS) and did 6 weeks of in-clinic therapy followed by 3 months of home-based therapy.
After in-clinic therapy, subjects in the Paired VNS group showed a 5.0 point improvement in the Upper Extremity Fugl-Meyer Assessment compared to 2.4 points in controls (p=0.001). The Wolf Motor Function Test score also improved after Paired VNS compared to controls (0.46 vs 0.16, p<0.0001). After 3 months of home-based therapy, the number of participants achieving a clinically meaningful response in upper limb impairment after Paired VNS was approximately twice that of controls.
The study showed that participants who received Paired VNS had clinically meaningful improvements in both motor impairment and function compared to controls. Improvements with Paired VNS were also observed in quality-of-life measures. There were no unexpected adverse events or serious adverse events associated with the Vivistim System.
The VNS System
The Vivistim Paired VNS System is designed to stimulate the vagus nerve during task-specific rehabilitation. Stimulation of the vagus nerve triggers release of brain neuromodulators including acetylcholine and norepinephrine that strengthens motor circuits associated with movement, enabling the brain to effectively relearn the task, MicroTransponder Inc explains in its release.
“Not only were the results clinically meaningful, the fact that these patients were at least nine months post-stroke and in some instances years out, points to the possibility that meaningful improvements can be achieved even years after a stroke.
“For too long, stroke patients have faced limited options for recovery. This new treatment signifies a breakthrough that could be life-changing for many stroke patients and also represents an approach that will certainly be explored for many other functional restoration applications in the future.”
— Charles Liu, who also serves as chief of innovation and research and chair of neurosurgery and orthopedics at Rancho Los Amigos National Rehabilitation Center
[Source(s): MicroTransponder Inc, Keck Medicine of USC, PR Newswire, Newswise]
Posted by Debbie Overman
The U.S. Food and Drug Administration has authorized the marketing of the IpsiHand, a new device indicated for use in patients 18 and older undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or increasing range of motion.
The IpsiHand Upper Extremity Rehabilitation System (IpsiHand System), from Neurolutions Inc, is a Brain-Computer-Interface (BCI) device that assists in rehabilitation for stroke patients with upper extremity—or hand, wrist and arm—disability.
“Thousands of stroke survivors require rehabilitation each year. Today’s authorization offers certain chronic stroke patients undergoing stroke rehabilitation an additional treatment option to help them move their hands and arms again and fills an unmet need for patients who may not have access to home-based stroke rehabilitation technologies.”
— Christopher M. Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health
Designed for Post-Stroke Rehab
Although stroke is a brain disease, it can affect the entire body and sometimes causes long-term disability such as complete paralysis of one side of the body (hemiplegia) or one-sided weakness (hemiparesis) of the body. Stroke survivors may have problems with the simplest of daily activities, including speaking, walking, dressing, eating and using the bathroom.
Post-stroke rehabilitation helps individuals overcome disabilities that result from stroke damage. The IpsiHand System uses non-invasive electroencephalography (EEG) electrodes instead of an implanted electrode or other invasive feature to record brain activity. The EEG data is then wirelessly conveyed to a tablet for analysis of the intended muscle movement (intended motor function) and a signal is sent to a wireless electronic hand brace, which in turn moves the patient’s hand. The device aims to help stroke patients improve grasping. The device is prescription-only and may be used as part of rehabilitation therapy.
The FDA assessed the safety and effectiveness of the IpsiHand System device through clinical data submitted by the company, including an unblinded study of 40 patients over a 12-week trial. All participants demonstrated motor function improvement with the device over the trial. Adverse events reported included minor fatigue and discomfort and temporary skin redness.
The IpsiHand System device should not be used by patients with severe spasticity or rigid contractures in the wrist and/or fingers that would prevent the electronic hand brace from being properly fit or positioned for use or those with skull defects due to craniotomy or craniectomy.
The IpsiHand System device was granted Breakthrough Device designation, which is a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The FDA reviewed the IpsiHand System device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type.
This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.
The FDA granted marketing authorization of the Neurolutions IpsiHand Upper Extremity Rehabilitation System to Neurolutions Inc.
[Source(s): US Food and Drug Administration, PR Newswire]
[Abstract] Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial
Long-term loss of arm function after ischaemic stroke is common and might be improved by vagus nerve stimulation paired with rehabilitation. We aimed to determine whether this strategy is a safe and effective treatment for improving arm function after stroke.
In this pivotal, randomised, triple-blind, sham-controlled trial, done in 19 stroke rehabilitation services in the UK and the USA, participants with moderate-to-severe arm weakness, at least 9 months after ischaemic stroke, were randomly assigned (1:1) to either rehabilitation paired with active vagus nerve stimulation (VNS group) or rehabilitation paired with sham stimulation (control group). Randomisation was done by ResearchPoint Global (Austin, TX, USA) using SAS PROC PLAN (SAS Institute Software, Cary, NC, USA), with stratification by region (USA vs UK), age (≤30 years vs >30 years), and baseline Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score (20–35 vs 36–50). Participants, outcomes assessors, and treating therapists were masked to group assignment. All participants were implanted with a vagus nerve stimulation device. The VNS group received 0·8 mA, 100 μs, 30 Hz stimulation pulses, lasting 0·5 s. The control group received 0 mA pulses. Participants received 6 weeks of in-clinic therapy (three times per week; total of 18 sessions) followed by a home exercise programme. The primary outcome was the change in impairment measured by the FMA-UE score on the first day after completion of in-clinic therapy. FMA-UE response rates were also assessed at 90 days after in-clinic therapy (secondary endpoint). All analyses were by intention to treat. This trial is registered at ClinicalTrials.gov, NCT03131960.
Between Oct 2, 2017, and Sept 12, 2019, 108 participants were randomly assigned to treatment (53 to the VNS group and 55 to the control group). 106 completed the study (one patient for each group did not complete the study). On the first day after completion of in-clinic therapy, the mean FMA-UE score increased by 5·0 points (SD 4·4) in the VNS group and by 2·4 points (3·8) in the control group (between group difference 2·6, 95% CI 1·0–4·2, p=0·0014). 90 days after in-clinic therapy, a clinically meaningful response on the FMA-UE score was achieved in 23 (47%) of 53 patients in the VNS group versus 13 (24%) of 55 patients in the control group (between group difference 24%, 6–41; p=0·0098). There was one serious adverse event related to surgery (vocal cord paresis) in the control group.
Vagus nerve stimulation paired with rehabilitation is a novel potential treatment option for people with long-term moderate-to-severe arm impairment after ischaemic stroke.
A stroke rehabilitation system, developed by MicroTransponder Inc and studied by a team at the University of Glasgow, has been shown to significantly improve arm impairment and function in people with long-term arm weakness after ischaemic stroke.
Long-term loss of arm function after ischaemic stroke is common, and the results of the study – published today in The Lancet – showed two to three times greater improvement with Vagus Nerve Stimulation (VNS) when it was combined with intense physical therapy, compared to intense physical therapy alone.
Approximately 80% of people with acute stroke have arm weakness, and as many as 50%-60% still have persistent problems six months later. There are currently few effective treatments to enhance arm recovery after stroke, and intense physical therapy is currently the best treatment option.
In the study – which looked at 108 people in the United States and the United Kingdom with moderate to severe arm problems – trial participants were randomised to intense physical therapy paired with active VNS or intense physical therapy paired with sham VNS (Control group).
VNS involves implant surgery, a bit like a cardiac pacemaker. Once implanted, the device stimulates the vagus nerve on the left side of the neck during intensive task-specific rehabilitation. The vagus nerve connects with areas of the brain that cause release of important neuromodulators or chemicals which, when combined with physical therapy, helps the brain ’re-learn’ movements.
After 6 weeks of out-patient therapy and a further ninety days of home based therapy, 47% of the people in the VNS group showed a clinically meaningful response versus 24% in the control group. People who received VNS also showed improvement over the control group in quality of life and activity measures.
Jesse Dawson, Professor of Stroke Medicine, at the University of Glasgow and principal investigator of the trial, said: “This is the first study to find clinically- and statistically-significant effects of a neuromodulation therapy for people with arm and hand weakness after chronic stroke.
“We saw improvement for the VNS group in both impairment and functional measures compared to Controls. In particular, the clinically meaningful response rate doubled with VNS for both impairment and functional outcomes. Importantly, the VNS doesn’t work alone – it adds to the effect of intensive rehabilitation”
Dr. Teresa Kimberley, PhD, PT, Professor and Director of the Brain Recovery Lab at MGH Institute of Health Professions, a senior investigator on the project through both the pilot and pivotal studies, added: “The results of this clinical study suggest that the addition of VNS enhances the effect of best practice stroke rehabilitation
“We are looking forward to potentially establishing the therapy as part a new standard of care for stroke rehabilitation. “
Many post stroke patients end up with an upper extremity that doesn’t cooperate, requiring the brain to relearn how to use it. This can be a difficult process often requiring a lot of mental stamina, so there’s a lot of efforts underway to help improve the speed and quality of recovery. At Washington University in St. Louis researchers have developed and tested a stroke rehabilitation system that reads brainwaves and in turn controls a robotic device attached to the affected arm.
The patient wears an electroencephalography (EEG) cap, which is connected to a computer capable of identifying when the patient is trying to move the arm. These signals are translated and sent to a robotic brace worn over the forearm, wrist, and fingers. As an intention is translated, the brace immediately moves to follow along with the patient’s wishes.
This process is repeated over and over, and in a study of chronic stroke patients who have essentially stopped improving, the system was able to help restore some arm movement.
The system is actually partially based on a recent realization that a small area on the same side of the brain is actually involved in moving an arm. This area is actually activated before the larger area on the opposite side of the brain that for long was thought as completely responsible for movement. Since the opposite side of the brain from the affected arm is what was damaged by a stroke, the above mentioned region on the same side of the brain is not affected and can be used as a trigger to identify when the person wants to move the disabled arm.
IpsiHand System designed for individuals with upper-extremity disability
by Nicole Lou, Staff Writer, MedPage Today April 23, 2021
FDA has authorized the Neurolutions IpsiHand Upper Extremity Rehabilitation System (IpsiHand System) for stroke survivors trying to regain hand, wrist, or arm function.
The IpsiHand System may be prescribed to stroke patients wishing to improve grasping as part of their rehabilitation therapy. The brain-computer-interface device uses non-invasive electroencephalography electrodes to record a person’s brain activity, and then moves an electronic hand brace according to the intended muscle movement.
“Thousands of stroke survivors require rehabilitation each year,” said Christopher Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices at the FDA, in a statement. “Today’s authorization offers certain chronic stroke patients undergoing stroke rehabilitation an additional treatment option to help them move their hands and arms again and fills an unmet need for patients who may not have access to home-based stroke rehabilitation technologies.”
Approval was based on a 40-person unblinded study in which all participants showed motor function improvement with the device over 12 weeks. Adverse events reported in the study included minor fatigue, discomfort, and temporary skin redness.
The IpsiHand System had been granted breakthrough device designation by the FDA and was authorized for marketing through the de novo premarket review pathway.
The device should not be used by patients who cannot be properly fitted for the electronic hand brace, nor those with skull defects due to craniotomy or craniectomy, the FDA cautioned.
- Nicole Lou is a reporter for MedPage Today, where she covers cardiology news and other developments in medicine. Follow