A single-center, assessor-blinded, randomized controlled clinical trial to test the safety and efficacy of a novel brain-computer interface controlled functional electrical stimulation (BCI-FES) intervention for gait rehabilitation in the chronic stroke population.

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.

A Home-Based Telerehabilitation Program for Patients With Stroke.

BACKGROUND: Although rehabilitation therapy is commonly provided after stroke, many patients do not derive maximal benefit because of access, cost, and compliance. A telerehabilitation-based program may overcome these barriers. We designed, then evaluated a home-based telerehabilitation system in patients with chronic hemiparetic stroke. METHODS: Patients were 3 to 24 months poststroke with stable arm motor deficits. Each received 28 days of telerehabilitation using a system delivered to their home. Each day consisted of 1 structured hour focused on individualized exercises and games, stroke education, and an hour of free play. RESULTS: Enrollees (n = 12) had baseline Fugl-Meyer (FM) scores of 39 ± 12 (mean ± SD). Compliance was excellent: participants engaged in therapy on 329/336 (97.9%) assigned days. Arm repetitions across the 28 days averaged 24,607 ± 9934 per participant. Arm motor status showed significant gains (FM change 4.8 ± 3.8 points, P = .0015), with half of the participants exceeding the minimal clinically important difference. Although scores on tests of computer literacy declined with age ( r = -0.92; P < .0001), neither the motor gains nor the amount of system use varied with computer literacy. Daily stroke education via the telerehabilitation system was associated with a 39% increase in stroke prevention knowledge ( P = .0007). Depression scores obtained in person correlated with scores obtained via the telerehabilitation system 16 days later ( r = 0.88; P = .0001). In-person blood pressure values closely matched those obtained via this system ( r = 0.99; P < .0001). CONCLUSIONS: This home-based system was effective in providing telerehabilitation, education, and secondary stroke prevention to participants. Use of a computer-based interface offers many opportunities to monitor and improve the health of patients after stroke.

Differences in physical characteristics and response to rehabilitation for patients with hand dystonia: musicians' cramp compared to writers' cramp.

STUDY DESIGN: Pre-Post, Mixed Factorial Trial. INTRODUCTION: Focal hand dystonia is a challenging movement disorder to rehabilitate in musicians and writers. PURPOSE OF THE STUDY: To compare the neuromusculoskeletal characteristics of those with writers' cramp (WC) and musicians' cramp (MC), and evaluate responsiveness to learning-based sensorimotor training. METHODS: Twenty-seven individuals (14 musicians, 13 writers) participated in 8 weeks of supervised therapy supplemented with a home program. Between-group differences on measures of musculoskeletal (physical), sensory, and motor performance were evaluated at baseline and post-intervention. RESULTS: Subjects with MC had a higher level of functional independence and better range of motion, but less strength in the affected upper limb than those of subjects with WC. Subjects with MC demonstrated greater accuracy on graphesthesia, kinesthesia, and localization at baseline. No between-group differences in motor performance were noted at baseline or post-intervention. Following individually adapted learning-based sensorimotor training, both groups improved in musculoskeletal (physical) parameters, sensory processing, and motor control; however, improvements on certain subtests differed by group. At follow-up, differences in posture, ROM, strength, graphesthesia, and kinesthesia persisted between the groups. CONCLUSIONS: Subjects with WC have different physical and performance risk factors compared with those of subjects with MC. Intervention paradigms are efficacious, but variable responses to rehabilitation occur.

Effect of sensory discrimination training on structure and function in patients with focal hand dystonia: a case series.

OBJECTIVE: To measure the effects of sensorimotor training based on the principles of neuroplasticity for patients with focal hand dystonia. DESIGN: Case series of 3 subjects with focal hand dystonia of the left hand, compared with age-matched normative controls. SETTING: Outpatient clinic. PARTICIPANTS: Three consecutive clinic patients-musicians with focal hand dystonia-who described a history of repetitive practice and performance (2 women; ages, 23 y and 35 y; 1 man; age, 24 y). INTERVENTION: Subjects were asked to stop performing the tasks that caused the abnormal movements, to participate in a wellness program (aerobics, postural exercises, stress free hand use), and to carry out supervised, attended, individualized, repetitive sensorimotor training activities at least once week for 12 weeks and reinforced daily at home. MAIN OUTCOME MEASURES: Standard tests documenting somatosensory hand representation, target-specific hand control, and clinical function. RESULTS: On the affected side, the 3 subjects improved an average of 86.8% on somatosensory hand representation, 117% on target-specific performance, 23.9% on fine motor skills, 22.7% on sensory discrimination, 31.9% on musculoskeletal skills, and 32.3% on independence. All 3 subjects improved 10% or more on 90% of the subtests with 20% improvement on 50% of the subtests. CONCLUSION: Individuals with focal hand dystonia who have a history of repetitive hand use can improve cortical somatosensory responses and clinical motor function after individualized sensorimotor training consistent with the principles of neural adaptation.