Stroke Clinical Trial
Official title:
Wearable Interactive Lower-limb Exoskeleton Robotic Device for Gait Training of Post-stroke Patients on Different Walking Conditions
A new lower-limb training system is introduced to enhance the clinical service for post-stroke lower limb rehabilitation and to assist the establishment of public clinical trial in different settings and share experiences on the robot-assisted functional training.
Stroke is caused by intracranial haemorrhage or thrombosis, which cuts off arterial supply to
brain tissue and usually damages the motor pathway of the central nervous system affecting
one side of the body. Reduced descending neural drive to the affected side could lead to
hemiplegia, which significantly influences the activity of daily living (ADL) of stroke
survivors (Singam, Ytterberg, Tham & von Koch, 2015). While the upper-limb motor impairment
could be compensated using the contralateral side for picking up or manipulating objects, the
loss of motor functionality on the lower limb would substantially limit the mobility and body
balance. Many stroke survivors are dependent on walking aids or manual support from
caregivers for standing and walking, otherwise they would have great risk of falling with
serious consequences (Tasseel-Ponche, Yelnik & Bonan, 2015).
Recent studies suggest stroke patients could relearn walking ability by developing
alternative neural circuitries through long-term adaptation process, known as
neuroplasticity. High-intensity, repetitive, and task-specific gait training is the key to
enhance gait recovery of hemiplegic stroke patients (Kreisei, Hennerici & Bäzner, 2007; Kleim
& Jones, 2008). The development of robot-assisted lower-limb exoskeleton devices has great
clinical potential in stroke rehabilitation. Many lower-limb exoskeleton robots are
clinically-available for non-ambulatory stroke patients to practice walking with passive
assistance on body-weight-supported treadmill training (BWSTT) (Morone, et al., 2017).
Existing robot-assisted gait training (RAGT) such as Lokomat and electromechanical Gait
Trainer provide automatic, rhythmic, and repetitive powered assistance to major lower-limb
joints at hips and knees bilaterally (Poli, Morone, Rosati & Masiero, 2013). Large-scale
randomized controlled trials (RCT) of these RAGT in combination with conventional therapies
show significantly more chronic stroke patients improved functional gait independency and ADL
than receiving conventional therapies alone (Pohl, et al., 2007; Schwartz, et al., 2009;
Hidler, et al., 2009; Mehrholz, et al., 2013). However, Hesse, Schmidt, Werner & Bardeleben
(2003) suggest the integration of robots into gait rehabilitation could merely be an
auxiliary tool for therapists to enhance training intensity and safety without increasing
their workload. Most clinically-available RAGT are bounded to treadmill with passive
assistance (van Peppen, et al., 2004; Morone, et al., 2017), but researches show
task-variations and active participation in gait training could improve retention of
newly-learnt skills and could promote generalization of training effects (Salbach, et al.,
2004; Kwon, Woo, Lee & Kim, 2015). Portable RAGT that allows active over-ground gait training
would be more promising especially for ambulatory stroke patients.
Robot-assisted ankle foot orthosis (AFO) and knee brace are good candidates of portable
exoskeleton devices for RAGT of hemiplegic stroke patients (Duerinck, et al., 2012; Zhang,
Davies & Xie, 2013; Mehrholz, et al., 2017). Conventional AFO is mainly designed for treating
foot drop gait abnormality with passive support in ankle dorsiflexion for foot clearance in
swing phase and shock absorption in loading response. Conventional knee brace is mainly
designed for body support in stance phase. The integration of robot assistance in the
affected ankle and/or knee joint could provide active power assistance that synchronises to
patients' voluntary residual ankle and/or knee movement. Long-term active power assistance
might stimulate experience-driven gait recovery or develop compensatory gait pattern to
facilitate gait (Kleim & Jones, 2008).
In order to translate robotic rehabilitation research into clinical application,
evidence-based clinical research should be carried out to test the safety and effectiveness
of the new devices or interventions on stroke patients (Backus, Winchester & Tefertiller,
2010). Many designs of robot-assisted AFO and knee braces have been proposed by different
research groups, but most of them reported only the results of feasibility tests, mainly on
healthy subjects with small sample sizes (Dollar & Herr, 2008; Shorter, et al., 2013; Alam,
Choudhury & Bin Mamat, 2014). Majority of previous studies concerned about the immediate
effects of wearing the robot-assisted AFOs and knee braces during walking, but few studies
investigated the long-term therapeutic effects of wearing the devices for RAGT of stroke
patients (Lo, 2012). In particular, systematic review by Mehrholz, et al. (2017) shows only
one RCT has evaluated the efficacy of ankle training using robot-assisted AFO but in seated
position, no RCT evaluated gait training using robot-assisted AFO on both over-ground walking
and stair ambulation.
In this study, the Exoskeleton Ankle Robot and Knee Robot have been proposed and evaluated as
a robot-assisted AFO and knee brace for gait training of stroke patients with foot drop gait
abnormality. Clinical application of robot-assisted AFO and knee brace on stroke patients has
to overcome some important challenges, such as to reduce weight loading on the leg, and to
achieve portability and adaptability to various walking environments. The Exoskeleton Ankle
Robot and Knee Brace aims: (1) to provide synchronised active ankle and/or knee power
assistance to facilitate walking, (2) to develop accurate and reliable method to classify
user walking intention in over-ground walking and stair ambulation, (3) to deliver training
protocol for RAGT of stroke patients with foot drop gait abnormality. The feasibility tests
and RCT of the Exoskeleton Ankle Robot and Knee Brace could validate the clinical value of
this new rehabilitation robot, and could potentially establish a new intervention of gait
rehabilitation for stroke patients.
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