Dataset Information

Exoskeleton-assisted gait training to improve gait in individuals with spinal cord injury: a pilot randomized study.

ABSTRACT: Background:Robotic wearable exoskeletons have been utilized as a gait training device in persons with spinal cord injury. This pilot study investigated the feasibility of offering exoskeleton-assisted gait training (EGT) on gait in individuals with incomplete spinal cord injury (iSCI) in preparation for a phase III RCT. The objective was to assess treatment reliability and potential efficacy of EGT and conventional physical therapy (CPT). Methods:Forty-four individuals were screened, and 13 were eligible to participate in the study. Nine participants consented and were randomly assigned to receive either EGT or CPT with focus on gait. Subjects received EGT or CPT, five sessions a week (1 h/session daily) for 3 weeks. American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS), 10-Meter Walk Test (10MWT), 6-Minute Walk Test (6MWT), Timed Up and Go (TUG) test, and gait characteristics including stride and step length, cadence and stance, and swing phase durations were assessed at the pre- and immediate post- training. Mean difference estimates with 95% confidence intervals were used to analyze the differences. Results:After training, improvement was observed in the 6MWT for the EGT group. The CPT group showed significant improvement in the TUG test. Both the EGT and the CPT groups showed significant increase in the right step length. EGT group also showed improvement in the stride length. Conclusion:EGT could be applied to individuals with iSCI to facilitate gait recovery. The subjects were able to tolerate the treatment; however, exoskeleton size range may be a limiting factor in recruiting larger cohort of patients. Future studies with larger sample size are needed to investigate the effectiveness and efficacy of exoskeleton-assisted gait training as single gait training and combined with other gait training strategies. Trial registration:Clinicaltrials.org, NCT03011099, retrospectively registered on January 3, 2017.

SUBMITTER: Chang SH

PROVIDER: S-EPMC5839068 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Exoskeleton-assisted gait training to improve gait in individuals with spinal cord injury: a pilot randomized study.

Chang Shuo-Hsiu SH Afzal Taimoor T Berliner Jeffrey J Francisco Gerard E GE

Pilot and feasibility studies 20180305

<h4>Background</h4>Robotic wearable exoskeletons have been utilized as a gait training device in persons with spinal cord injury. This pilot study investigated the feasibility of offering exoskeleton-assisted gait training (EGT) on gait in individuals with incomplete spinal cord injury (iSCI) in preparation for a phase III RCT. The objective was to assess treatment reliability and potential efficacy of EGT and conventional physical therapy (CPT).<h4>Methods</h4>Forty-four individuals were screen ...[more]

PMID: 29556414

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Project description:BACKGROUND:Powered exoskeleton can improve the mobility for people with movement deficits by providing mechanical support and facilitate the gait training. This pilot study evaluated the effect of gait training using a newly developed powered lower limb exoskeleton robot for individuals with complete spinal cord injury (SCI). METHODS:Two participants with a complete SCI were recruited for this clinical study. The powered exoskeleton gait training was 8 weeks, 1 h per session, and 2 sessions per week. The evaluation was performed before and after the training for (1) the time taken by the user to don and doff the powered exoskeleton independently, (2) the level of exertion perceived by participants while using the powered exoskeleton, and (3) the mobility performance included the timed up-and-go test, 10-m walk test, and 6-min walk test with the powered exoskeleton. The safety of the powered exoskeleton was evaluated on the basis of injury reports and the incidence of falls or imbalance while using the device. RESULTS:The results indicated that the participants were donning and doffing the powered lower limb exoskeleton robot independently with a lower level of exertion and walked faster and farther without any injury or fall incidence when using the powered exoskeleton than when using a knee-ankle-foot orthosis. Bone mineral densities was also increased after the gait training. No adverse effects, such as skin abrasions, or discomfort were reported while using the powered exoskeleton. CONCLUSIONS:The findings demonstrated that individuals with complete SCI used the powered lower limb exoskeleton robot independently without any assistance after 8 weeks of powered exoskeleton gait training. TRIAL REGISTRATION:Trial registration: National Taiwan University Hospital. TRIAL REGISTRATION NUMBER:201210051RIB . Name of registry: Hui-Fen Mao. URL of registry: Not available. Date of registration: December 12th, 2012. Date of enrolment of the first participant to the trial: January 3rd, 2013.

Project description:The closed-loop control of rehabilitative technologies by neural commands has shown a great potential to improve motor recovery in patients suffering from paralysis. Brain-machine interfaces (BMI) can be used as a natural control method for such technologies. BMI provides a continuous association between the brain activity and peripheral stimulation, with the potential to induce plastic changes in the nervous system. Paraplegic patients, and especially the ones with incomplete injuries, constitute a potential target population to be rehabilitated with brain-controlled robotic systems, as they may improve their gait function after the reinforcement of their spared intact neural pathways. This paper proposes a closed-loop BMI system to control an ambulatory exoskeleton-without any weight or balance support-for gait rehabilitation of incomplete spinal cord injury (SCI) patients. The integrated system was validated with three healthy subjects, and its viability in a clinical scenario was tested with four SCI patients. Using a cue-guided paradigm, the electroencephalographic signals of the subjects were used to decode their gait intention and to trigger the movements of the exoskeleton. We designed a protocol with a special emphasis on safety, as patients with poor balance were required to stand and walk. We continuously monitored their fatigue and exertion level, and conducted usability and user-satisfaction tests after the experiments. The results show that, for the three healthy subjects, 84.44 ± 14.56% of the trials were correctly decoded. Three out of four patients performed at least one successful BMI session, with an average performance of 77.6 1 ± 14.72%. The shared control strategy implemented (i.e., the exoskeleton could only move during specific periods of time) was effective in preventing unexpected movements during periods in which patients were asked to relax. On average, 55.22 ± 16.69% and 40.45 ± 16.98% of the trials (for healthy subjects and patients, respectively) would have suffered from unexpected activations (i.e., false positives) without the proposed control strategy. All the patients showed low exertion and fatigue levels during the performance of the experiments. This paper constitutes a proof-of-concept study to validate the feasibility of a BMI to control an ambulatory exoskeleton by patients with incomplete paraplegia (i.e., patients with good prognosis for gait rehabilitation).

Dataset Information

Exoskeleton-assisted gait training to improve gait in individuals with spinal cord injury: a pilot randomized study.

Publications

Exoskeleton-assisted gait training to improve gait in individuals with spinal cord injury: a pilot randomized study.

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