Background

Direct brain control of overground walking in those with paraplegia due to spinal cord injury (SCI) has not been achieved. Invasive brain-computer interfaces (BCIs) may provide a permanent solution to this problem by directly linking the brain to lower extremity prostheses. To justify the pursuit of such invasive systems, the feasibility of BCI controlled overground walking should first be established in a noninvasive manner. To accomplish this goal, we developed an electroencephalogram (EEG)-based BCI to control a functional electrical stimulation (FES) system for overground walking and assessed its performance in an individual with paraplegia due to SCI.

Methods

An individual with SCI (T6 AIS B) was recruited for the study and was trained to operate an EEG-based BCI system using an attempted walking/idling control strategy. He also underwent muscle reconditioning to facilitate standing and overground walking with a commercial FES system. Subsequently, the BCI and FES systems were integrated and the participant engaged in several real-time walking tests using the BCI-FES system. This was done in both a suspended, off-the-ground condition, and an overground walking condition. BCI states, gyroscope, laser distance meter, and video recording data were used to assess the BCI performance.

Results

During the course of 19 weeks, the participant performed 30 real-time, BCI-FES controlled overground walking tests, and demonstrated the ability to purposefully operate the BCI-FES system by following verbal cues. Based on the comparison between the ground truth and decoded BCI states, he achieved information transfer rates >3 bit/s and correlations >0.9. No adverse events directly related to the study were observed.

Conclusion

This proof-of-concept study demonstrates for the first time that restoring brain-controlled overground walking after paraplegia due to SCI is feasible. Further studies are warranted to establish the generalizability of these results in a population of individuals with paraplegia due to SCI. If this noninvasive system is successfully tested in population studies, the pursuit of permanent, invasive BCI walking prostheses may be justified. In addition, a simplified version of the current system may be explored as a noninvasive neurorehabilitative therapy in those with incomplete motor SCI.

Objective

Robot-assisted movement training can help individuals with stroke reduce arm and hand impairment, but robot therapy is typically only about as effective as conventional therapy. Refining the way that robots assist during training may make them more effective than conventional therapy. Here we measured the therapeutic effect of a robot that required individuals with a stroke to achieve virtual tasks in three dimensions against gravity.

Design

The robot continuously estimated how much assistance patients needed to perform the tasks and provided slightly less assistance than needed in order to reduce patient slacking. Individuals with a chronic stroke (n = 26, baseline upper extremity Fugl-Meyer score = 23 ± 8) were randomized into two groups and underwent 24 one hour training sessions over 2 months. One group received the assist-as-needed robot training and the other received conventional table top therapy with the supervision of a physical therapist.

Results

Training helped both groups significantly reduce their motor impairment, as measured by the primary outcome measure, the Fugl-Meyer score, but the improvement was small (3.0 ± 4.9 points for robot therapy, versus 0.9 ± 1.7 for conventional therapy). There was a trend for greater reduction for the robot trained group (p = 0.07). The robot group largely sustained this gain at the three-month follow-up. The robot-trained group also experienced significant improvements in Box and Blocks score and hand grip strength, while the control group did not, but these improvements were not sustained at follow-up. In addition, the robot-trained group showed a trend toward greater improvement in sensory function, as measured by the Nottingham Sensory Test (p = 0.06).

Conclusions

These results suggest that, in patients with chronic stroke and moderate-severe deficits, assisting in three dimensional virtual tasks with an assist-as-needed controller may make robotic training more effective than conventional table top training.

Background

Standardizing scoring reduces variability and increases accuracy. A detailed scoring and training method for the Fugl-Meyer motor assessment (FMA) is described and assessed, and implications for clinical trials considered.

Methods

A standardized FMA scoring approach and training materials were assembled, including a manual, scoring sheets, and instructional video plus patient videos. Performance of this approach was evaluated for the upper extremity portion.

Results

Inter- and intrarater reliability in 31 patients were excellent (intraclass correlation coefficient = 0.98-0.99), validity was excellent (r = 0.74-0.93, P < .0001), and minimal detectable change was low (3.2 points). Training required 1.5 hours and significantly reduced error and variance among 50 students, with arm FMA scores deviating from the answer key by 3.8 ± 6.2 points pretraining versus 0.9 ± 4.9 points posttraining. The current approach was implemented without incident into training for a phase II trial. Among 66 patients treated with robotic therapy, change in FMA was smaller (P ≤ .01) at the high and low ends of baseline FMA scores.

Conclusions

Training with the current method improved accuracy, and reduced variance, of FMA scoring; the 20% FMA variance reduction with training would decrease sample size requirements from 137 to 88 in a theoretical trial aiming to detect a 7-point FMA difference. Minimal detectable change was much smaller than FMA minimal clinically important difference. The variation in FMA gains in relation to baseline FMA suggests that future trials consider a sliding outcome approach when FMA is an outcome measure. The current training approach may be useful for assessing motor outcomes in restorative stroke trials.

The current treatment for ambulation after spinal cord injury (SCI) is to substitute the lost behavior with a wheelchair; however, this can result in many co-morbidities. Thus, novel solutions for the restoration of walking, such as brain-computer interfaces (BCI) and functional electrical stimulation (FES) devices, have been sought. This study reports on the first electroencephalogram (EEG) based BCI-FES system for overground walking, and its performance assessment in an individual with paraplegia due to SCI. The results revealed that the participant was able to purposefully operate the system continuously in real time. If tested in a larger population of SCI individuals, this system may pave the way for the restoration of overground walking after SCI.

Abstract Background To date, the limited degrees of freedom (DOF) of most robotic training devices hinders them from providing functional training following stroke. We developed a 6-DOF exoskeleton (“BONES”) that allows movement of the upper limb to assist in rehabilitation. The objectives of this pilot study were to evaluate the impact of training with BONES on function of the affected upper limb, and to assess whether multijoint functional robotic training would translate into greater gains in arm function than single joint robotic training also conducted with BONES. Methods Twenty subjects with mild to moderate chronic stroke participated in this crossover study. Each subject experienced multijoint functional training and single joint training three sessions per week, for four weeks, with the order of presentation randomized. The primary outcome measure was the change in Box and Block Test (BBT). The secondary outcome measures were the changes in Fugl-Meyer Arm Motor Scale (FMA), Wolf Motor Function Test (WMFT), Motor Activity Log (MAL), and quantitative measures of strength and speed of reaching. These measures were assessed at baseline, after each training period, and at a 3-month follow-up evaluation session. Results Training with the robotic exoskeleton resulted in significant improvements in the BBT, FMA, WMFT, MAL, shoulder and elbow strength, and reaching speed (p < 0.05); these improvements were sustained at the 3 month follow-up. When comparing the effect of type of training on the gains obtained, no significant difference was noted between multijoint functional and single joint robotic training programs. However, for the BBT, WMFT and MAL, inequality of carryover effects were noted; subsequent analysis on the change in score between the baseline and first period of training again revealed no difference in the gains obtained between the types of training. Conclusions Training with the 6 DOF arm exoskeleton improved motor function after chronic stroke, challenging the idea that robotic therapy is only useful for impairment reduction. The pilot results presented here also suggest that multijoint functional robotic training is not decisively superior to single joint robotic training. This challenges the idea that functionally-oriented games during training is a key element for improving behavioral outcomes. Trial registration NCT01050231.

Objective

Many patients with subacute stroke rely on the nonparetic arm and leg to propel manual wheelchairs. We designed a bimanual, lever-driven wheelchair (LARA) to promote overground mobility and hemiparetic arm exercise. This study measured the feasibility of using LARA to increase arm movement, achieve mobility, and improve arm motor recovery (clinicaltrials.gov/ct2/show/NCT02830893).

Design

Randomized, assessor-blind, controlled trial.

Setting

Two inpatient rehabilitation facilities.

Subjects

Nineteen patients with subacute stroke (1 week to 2 months post-stroke) received 30 minutes extra arm movement practice daily, while admitted to inpatient rehabilitation (n = 10) or before enrollment in outpatient therapy (n = 9).

Interventions

Patients were randomized to train with the LARA wheelchair (n = 11) or conventional exercises with a rehabilitation therapist (n = 8).

Main measures

Number of arm movements per training session; overground speed; Upper Extremity Fugl-Meyer score at three-month follow-up.

Results

Participants who trained with LARA completed 254 (median) arm movements with the paretic arm each session. For three participants, LARA enabled wheelchair mobility at practical indoor speeds (0.15-0.30 m/s). Fugl-Meyer score increased 19 ± 13 points for patients who trained with LARA compared to 14 ± 7 points with conventional exercises (P = 0.32). Secondary measures including shoulder pain and increased tone did not differ between groups. Mixed model analysis found significant interaction between LARA training and treatment duration (P = 0.037), informing power analysis for future investigation.

Conclusions

Practising arm movement with a lever-driven wheelchair is a feasible method for increasing arm movement early after stroke. It enabled wheelchair mobility for a subset of patients and shows potential for improving arm motor recovery.

BACKGROUND: In the United States, there are over seven million stroke survivors, with many facing gait impairments due to foot drop. This restricts their community ambulation and hinders functional independence, leading to several long-term health complications. Despite the best available physical therapy, gait function is incompletely recovered, and this occurs mainly during the acute phase post-stroke. Therapeutic options are limited currently. Novel therapies based on neurobiological principles have the potential to lead to long-term functional improvements. The Brain-Computer Interface (BCI) controlled Functional Electrical Stimulation (FES) system is one such strategy. It is based on Hebbian principles and has shown promise in early feasibility studies. The current study describes the BCI-FES clinical trial, which examines the safety and efficacy of this system, compared to conventional physical therapy (PT), to improve gait velocity for those with chronic gait impairment post-stroke. The trial also aims to find other secondary factors that may impact or accompany these improvements and establish the potential of Hebbian-based rehabilitation therapies. METHODS: This Phase II clinical trial is a two-arm, randomized, controlled, longitudinal study with 66 stroke participants in the chronic (> 6 months) stage of gait impairment. The participants undergo either BCI-FES paired with PT or dose-matched PT sessions (three times weekly for four weeks). The primary outcome is gait velocity (10-meter walk test), and secondary outcomes include gait endurance, range of motion, strength, sensation, quality of life, and neurophysiological biomarkers. These measures are acquired longitudinally. DISCUSSION: BCI-FES holds promise for gait velocity improvements in stroke patients. This clinical trial will evaluate the safety and efficacy of BCI-FES therapy when compared to dose-matched conventional therapy. The success of this trial will inform the potential utility of a Phase III efficacy trial. TRIAL REGISTRATION: The trial was registered as BCI-FES Therapy for Stroke Rehabilitation on February 19, 2020, at clinicaltrials.gov with the identifier NCT04279067.