Synergy-based functional electrical stimulation and robotic-assisted for retraining reach-to-grasp in stroke: a study protocol for a randomized controlled trial.

BACKGROUND: Stroke survivors have long-term upper limb impairment, which impacts the quality of life (QOL) and social reintegration, but there is lack of effective therapeutic strategies and novel technologies. Customized multi-muscle functional electrical stimulation (FES) based on the muscle synergy of healthy adults and robotic-assisted therapy (RAT) have been proved efficacy respectively. Synergy-based FES combined with RAT can be a novel and more effective therapy for upper limb recovery of stroke survivors from the perspective of synergistic enhancement. However, few studies have examined the effectiveness of combined synergy-based FES and RAT, especially for motor control evaluated by reach-to-grasp (RTG) movements. The main objective of the following research protocol is to evaluate the effectiveness and efficacy, as well as adoptability, of FES-RAT and FES or RAT rehabilitation program for upper limb function improvement after stroke. METHODS: This will be an assessor-blinded randomized controlled trial involving a 12-week intervention and a 6-month follow-up. Stratified randomization will be used to equally and randomly assign 162 stroke patients into the FES + conventional rehabilitation program (CRP) group, RAT + CRP group and FES-RAT + CRP group. Interventions will be provided in 5 sessions per week, with a total of 60 sessions. The primary outcome measurements will include the Fugl-Meyer Assessment and Biomechanical Assessment of RTG movements. The secondary outcome measurements will include quality of life and brain neuroplasticity assessments by MRI. Evaluations will be performed at five time points, including at baseline, 6 weeks and 12 weeks from the start of treatment, and 3 months and 6 months following the end of treatment. A two-way analysis of variance with repeated measures will be applied to examine the main effects of the group, the time factor and group-time interaction effects. DISCUSSION: The results of the study protocol will provide high quality evidence for integrated synergy-based FES and RAT, and synergy-based FES alone and guide the design of more effective treatment methods for stroke rehabilitation. TRIAL REGISTRATION: ChiCTR2300071588.

Is Leg-Driven Treadmill-Based Exoskeleton Robot Training Beneficial to Poststroke Patients: A Systematic Review and Meta-analysis.

OBJECTIVE: The aim of the study is to systematically review the effects of leg-driven treadmill-based exoskeleton robot training on balance and walking ability in poststroke patients. DESIGN: The PubMed, Cochrane Library, Embase, Web of Science, Medline, CNKI, VIP, and Wanfang databases were searched from inception to August 2021. The literature quality was evaluated using Cochrane Handbook. Primary outcomes include the Functional Ambulation Category Scale and Berg Balance Scale, and secondary outcomes include the 10 meter walk test, 6 minute walk test, and gait assessment cadence were analyzed. RESULTS: Seventeen randomized controlled trials were included in the systematic review, 15 studies in meta-analysis. Primary outcomes showed no significant difference in the Functional Ambulation Category Scale score; subgroup with the exoskeleton robot + conventional therapy of the Berg Balance Scale score was significantly increased; secondary outcomes showed no significance in 6 minute walk test or 10 meter walk test. The cadence score increased for the subgroup with an onset of more than 6 mos in the treatment group. The control group performed better than the subgroup with an onset of less than 6 mos. CONCLUSIONS: Leg-driven treadmill-based exoskeleton robot training can improve balance function in poststroke patients and is beneficial for patients with an onset of greater than 6 mos. However, there is no evidence to support the efficacy of walking ability.