The benefits of using robots (HAL®) to help stroke patients in this day and age
Below is my CAT (Critically Appraised Topic) which is a short summary of the best available evidence to answer a clinical question.
Critically Appraised Topic:
Hybrid Assistive Limb® (HAL®) gait training for patients post-stroke compared to conventional gait training (CGT) with a physical therapist
Clinical question/ PICO
My patient is a 65-year-old male 6 months post CVA (Right ACA). We utilized conventional gait training to increase motor function and gait and have found some success. Brooks Rehabilitation recently partnered up with Cyberdyne, INC to introduce the advanced robotic treatment device known as HAL® (Hybrid Assistive Limb).1Brooks has been using this Hybrid Assistive Limb® (HAL®) technology to treat patients with spinal cord injuries (SCI) successfully but I would like to know if using the Hybrid Assistive Limb® (HAL®) exoskeleton more effective than conventional gait training (CGT) with a physical therapist?
P = adults post-stroke (acute or chronic)
I = gait training with Hybrid Assistive Limb ® (HAL®)
C = traditions gait training with skilled and experienced physical therapist
O = safety and effectiveness to improve motor function and gait
The preferred study type: Randomized controlled study and nonrandomized pilot study with concurrent control
Search strategy
PubMed:
(("gait"[MeSH Terms] OR "gait"[All Fields]) AND ("stroke"[MeSH Terms] OR "stroke"[All Fields]) AND exoskeleton[All Fields]) AND (Clinical Trial[ptyp] AND "2013/08/07"[PDat] : "2018/08/05"[PDat])
PubMed result: 7 papers, of which 2 Pilot studies and 2 randomized trials (search date Aug 5, 2018)
Search outcome
From the 7 reviews, 5 were irrelevant or not adequate. Two remaining, a recent randomized controlled study and a recent nonrandomized pilot study with concurrent control were included for critical appraisal.
Introduction
In the United States stroke is the leading cause of serious, long-term disability. Every year, approximately 795,000 people suffer a stroke.2,3Approximately 20% of people who suffer from a stroke are wheelchair bound and another 70% will have difficulty walking and/or reduced velocity in the gait. 4The research has shown that if someone is able to walk after a stroke this decreased velocity suggests there is an increased probability of fall risk.5“Falls have a proven association with mortality, morbidity, reduced functionality, and premature nursing home admissions”6 as well as an economic financial cost that estimates falls totaling more than $50 billion in 2015.7It is in our vision statements as physical therapists to “Transform society by optimizing movement to improve the human experience.”8If we can thrive for the best evidence-based practice and reduce the risk of patients falling after a stroke we can help transform society by increasing patients quality of life after a stroke as well as decrease the financial burden that is associated with falls in our country. The purpose of this critical appraisal is to review the experimental research pertaining to the use of specifically the Hybrid Assistive Limb ® (HAL®) exoskeleton to improve walking independence compared to conventional gait training (CGT). This can help determine a patient’s plan of care and help improve what clinics can provide to improve patient’s outcomes.
What makes HAL® different than a normal exoskeleton?
Some normal exoskeletons are used to just support and hold the patient up by having leg joints that are similar to the patient’s joint to mimic normal gait patterns. These joints have actuators in the joints that control the motion to mimic normal gait. HAL® as well as having robotic joints has two separate modes. The two modes are cybernic voluntary control (CVC) and cybernic autonomous control (CAC).
CVC- This mode uses motors driven by the patient's own neuro-muscular activity. The patient has skin sensors that read the electrical signals that are attached to the corresponding muscles of walking. 14
CAC- This mode is used when there is no electric signal to the patient's limbs and the motors are controlled to mimic normal gait according to foot-floor contact and pressure sensors in the shoe. 14
Here is how Brooks Rehabilitation is using HAL® for spinal cord injuries (SCI).
Results
Key results of the Pubmed systematic review are summarized in the evidence table below
Stroke and conventional gait training using HAL ®
All the studies integrated the use of HAL ® single leg gait training compared to CGT and found beneficial use of the new wearable technology of HAL®. Watanabe et al 20139,10 concentrated on sub-acute or stroke patients in the recovery phase with more recent stroke patients being within the last 6 months. This study also did not specify the criteria of the HAL® training group if it was using a speed-dependent treadmill or steady speed flat surface training. There has been research that has concluded that speed-depending gait training is beneficial for sub-acute stroke patients compared to CGT.12 The study did have a more consistent training schedule of providing 3 times a week but participants only participated for 4 weeks (12 sessions in one months time). The authors did find a significant improvement in the FAC for short-term and medium-term effects of using HAL® but did not see any differences in the other outcome measures. This study was designed to be exploratory in nature and acknowledges the need for further randomized controlled studies to conclude long-term effects of HAL® compared to CGT with a physical therapist in stroke patients in the recovery phase.
Stroke and Speed-dependent treadmill training using HAL ®
Yoshimoto et al 201511 concentrated more on the chronic stroke population since the majority of the motor deficits in the stroke population are completed within the first 6 months. This study looked at the use of HAL® on the chronic stroke population and found significant improvement in all outcome measures used. This study did describe the use of speed-dependent treadmill gait training with the HAL® group which brings into consideration the use of HAL® with speed-dependent treadmill training or HAL ® with steady-speed conventional floor training. While the study was well designed it is unclear if there was more benefit from the use of HAL® or if the improvements in the outcomes measures were more due to the use of the combination of HAL® and speed-dependent treadmill training. There must be more research to determine if the improvements are just HAL® or the speed training aspect. The authors did disclose that further research needs to be done, such as a randomized controlled trial including follow-up periods after training to provide more conclusive evidence on the efficacy of HAL® compared to CGT.
Clinical bottom line
According to the research, there is evidence to support the use of HAL® (Hybrid Assistive Limb) to improve motor function and independent gait in patient post stroke rather than solely traditional conventional gait training with a physical therapist. There are differences in the studies, which focused on different subgroups of patients being in the recovery-phase while the other study concentrated on chronic stroke patients. Both studies consisted of a limited number of participants so generalization to the entire stroke population is difficult to confirm but it does give us insight into the mater. According to Watanabe et al 20139,10 if patients are in the recovery phase of stroke the research shows there is a significant improvement in short to medium-term gait training with HAL® to improve patients independence and walking. And according to Yoshimoto et al 201511 patients in the chronic phase of gait CGT can help maintain a their ability to ambulate instead of letting it deteriorate and HAL® (Hybrid Assistive Limb) training will significantly improve the gait speed with less treatment sessions which in turn can reduce the risk of falls as well as decrease the amount of therapy needed to help recovery. More research is needed to compare stroke patients in the recovery phase of stroke using the HAL® with speed-dependent treadmill training and also to see if there is a combination of HAL® and CGT that could be most beneficial. There have been studies on the use of Electromechanical-assisted gait training in combination with physical therapy improving the independence of walking in stroke patients but this included the use of robot-driven exoskeleton orthosis or an electromechanical solution.13The use of HAL® (Hybrid Assistive Limb) for both chronic and recovery phase stroke patients needs to be researched more but the research is promising to use this new technology to get significant improvements in our patients in a shorter amount of time. Using HAL® on CVC mode will allow patients to use their voluntary control to improve their gait vs just re-learning how to use robotic joints to control their movements. Clinicians should not discount the use of CGT or HAL® as both can be beneficial to their patients but this just fuels the fire the do more research. Clinicians should always be using evidence-based practice and trying to do the best for their patients so with this promising research we can begin performing practice-based evidence and promote the use of new technologies as well as research this new and upcoming practice. We should be advocating for our patients to get the best outcomes for them and if there is access to HAL® we should be pushing the use of this for our patients as well as continuing the research to improve the reliability of validity of this new technology.
References:
Revolutionary Robotic Treatment For Patients With Spinal Cord Injuries Now Available In United States. https://www.brooksrehab.org/news/revolutionary-robotic-treatment-for-patients-with-spinal-cord-injuries-now-available-in-united-states/. Published March 2, 2018. Accessed August 7, 2018.
Centers for Disease Control and Prevention. https://www.cdc.gov/stroke/. Published May 3, 2018. Accessed August 9, 2018.
Ovbiagele B, Nguyen-Huynh MN. Stroke Epidemiology: Advancing Our Understanding of Disease Mechanism and Therapy. Neurotherapeutics. 2011;8(3):319-329. doi:10.1007/s13311-011-0053
Jørgensen HS, Nakayama H, Raaschou HO, Olsen TS. Recovery of walking function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil 1995;76:27-32.
Abu Samah Z, Mohd Nordin N, Shahar S, Singh D. Review Article: Can gait speed test be used as a falls risk screening tool in community-dwelling older adults? A review. Polish Annals Of Medicine [serial online]. February 1, 2016;23:61-67. Available from: ScienceDirect, Ipswich, MA. Accessed August 9, 2018.
Dionyssiotis Y. Analyzing the problem of falls among older people. International Journal of General Medicine. 2012;5:805-813. doi:10.2147/IJGM.S32651.
Florence CS, Bergen G, Atherly A, Burns ER, Stevens JA, Drake C. Medical Costs of Fatal and Nonfatal Falls in Older Adults. Journal of the American Geriatrics Society, 2018 March, DOI:10.1111/jgs.15304
Bellamy J. Vision Statement for the Physical Therapy Profession and Guiding Principles to Achieve the Vision. APTA. http://www.apta.org/Vision/. Accessed August 14, 2018.
Watanabe H, Goto R, Tanaka N, Matsumura A, Yanagi H. Effects of gait training using the Hybrid Assistive Limb® in recovery-phase stroke patients: A 2-month follow-up, randomized, controlled study. NeuroRehabilitation. 2017;40(3):363-367. doi:10.3233/nre-161424.
Watanabe H, Tanaka N, Inuta T, Saitou H, Yanagi H. Original article: Locomotion Improvement Using a Hybrid Assistive Limb in Recovery Phase Stroke Patients: A Randomized Controlled Pilot Study. Archives Of Physical Medicine And Rehabilitation [serial online]. November 1, 2014;95:2006-2012. Available from: ScienceDirect, Ipswich, MA. Accessed August 9, 2018.
Yoshimoto T, Shimizu I, Hiroi Y, Kawaki M, Sato D, Nagasawa M. Feasibility and efficacy of high-speed gait training with a voluntary driven exoskeleton robot for gait and balance dysfunction in patients with chronic stroke. International Journal of Rehabilitation Research. 2015;38(4):338-343. doi:10.1097/mrr.0000000000000132.
Mak, Mky, and Kwk Lau. “Speed-Dependent Treadmill Training Is Effective to Improve Gait and Balance Performance in Patients with Sub-Acute Stroke.” Journal of Rehabilitation Medicine, vol. 43, no. 8, 2011, pp. 709–713., doi:10.2340/16501977-0838.
Mehrholz, J., Elsner, B., Werner, C., Kugler, J.,&Pohl, M. (2013). Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev, 7, CD006185.
Grüneberg P, Kadone H, Kuramoto N, et al. Robot-assisted voluntary initiation reduces control-related difficulties of initiating joint movement: A phenomenal questionnaire study on shaping and compensation of forward gait. Plos One. 2018;13(3). doi:10.1371/journal.pone.0194214.