Therapeutic and Orthotic Effects of Soft Robotic Exosuits for Post-Stroke Gait Recovery: A Systematic Review

Description This systematic review evaluates the therapeutic and orthotic effects of soft robotic exosuits on post-stroke gait recovery, with the primary purpose of distinguishing between immediate biomechanical benefits during device use (orthotic effects) and retained functional improvements after training without the device (therapeutic effects). Background and Rationale: Approximately 50-60% of stroke survivors experience persistent gait impairments that severely limit functional independence and quality of life. Traditional rigid exoskeleton systems, while widely used, face inherent limitations including heavy weight, high inertia, fixed joint axes that restrict natural movement, and a tendency to induce passive reliance rather than active motor learning. Soft robotic exosuits—utilizing lightweight textile-based materials and cable-driven actuation—represent an emerging paradigm that overcomes these constraints by conforming to natural body contours, reducing mechanical impedance, and promoting active patient engagement during training. Research Gap: Despite rapid technological advances and recent high-quality randomized controlled trials, existing systematic reviews have not adequately incorporated the latest evidence or clearly distinguished between two fundamentally different types of benefits: (1) orthotic effects—immediate improvements in gait mechanics, energy efficiency, and compensatory movement reduction while wearing the device; and (2) therapeutic effects—retained motor learning and functional recovery that persist after training, measured without the device. This analytical ambiguity creates a critical knowledge gap preventing clinicians from making evidence-based decisions about whether to prescribe soft exosuits as assistive devices for daily use or as rehabilitation training tools for neuroplastic recovery. Study Objectives: This review systematically synthesizes evidence from 16 controlled studies (n=323 stroke patients) published between 2015 and 2026, following PRISMA 2020 guidelines. We exclusively focus on soft wearable robots (defined by flexible textile-based construction and cable/pneumatic actuation) while excluding traditional rigid frame-based exoskeletons. Included studies encompass randomized controlled trials, crossover trials, pilot studies, and case studies with within-subject controlled comparisons across acute, subacute, and chronic stroke populations. Primary Outcomes: Therapeutic effects: Post-training gait speed (10-Meter Walk Test), walking endurance (6-Minute Walk Test), and motor recovery (Fugl-Meyer Assessment) measured without the device after training periods ranging from 5 days to 12 weeks Orthotic effects: Immediate reductions in metabolic cost of walking (oxygen consumption), instantaneous gait speed improvements, paretic propulsion augmentation, and correction of pathological compensatory movements (hip hiking, circumduction, foot drop) measured with the device during same-day assessments Secondary Outcomes: Balance (Berg Balance Scale, Timed Up and Go), functional independence (FIM, Barthel Index), biomechanical parameters (EMG muscle activation, joint kinematics, spatiotemporal gait parameters), quality of life measures, and comprehensive safety profiles including adverse events, falls, skin integrity issues, and adherence rates. Methodological Approach: Risk of bias was assessed using Cochrane RoB 2.0 for randomized trials (n=3) and MINORS (Methodological Index for Non-Randomized Studies) for non-randomized studies (n=13). Due to substantial clinical, methodological, and statistical heterogeneity across device types (ankle-assistive, hip-assistive, multi-joint), intervention protocols (single-session acute studies vs. 2-12 week training programs), outcome measurement methods, and study populations, we conducted structured narrative synthesis organized by effect type and outcome domain rather than quantitative meta-analysis. Evidence was systematically categorized using comprehensive evidence tables distinguishing device specifications, training dose (session frequency, duration, total hours), control conditions, and effect magnitudes relative to minimal clinically important difference (MCID) thresholds. Expected Outcomes and Clinical Implications: We anticipate demonstrating that soft robotic exosuits provide dual benefits: (1) immediate orthotic advantages including 10-15% reductions in metabolic cost, biomechanical correction of pathological gait patterns, and increased walking speed/distance while wearing the device; and (2) meaningful therapeutic gains including clinically significant improvements in gait speed (≥0.10 m/s, exceeding MCID) and walking endurance that are retained after training without the device, indicating genuine motor re-learning rather than device dependency. We expect these effects to be moderated by intervention duration (longer training yields greater therapeutic effects), training intensity (high-intensity protocols enhance motor learning), device type (ankle vs. hip assistance target different biomechanical deficits), and stroke chronicity (chronic patients may show greater capacity for motor learning with intensive task-specific training). Safety profiles are expected to be excellent with minimal adverse events due to compliant textile-based design, supporting feasibility across diverse rehabilitation settings from acute inpatient care to chronic community-based training. Significance: This review addresses a critical evidence gap by providing the first comprehensive synthesis that systematically separates orthotic from therapeutic effects, incorporates the most recent high-quality evidence through February 2026, and focuses exclusively on soft exosuits rather than conflating them with rigid systems. Findings will inform evidence-based clinical decision-making regarding optimal patient selection, device prescription strategies (assistive device vs. training tool), intervention protocols (dose, duration, intensity), and integration into stroke rehabilitation pathways. By clarifying both immediate functional benefits and long-term neuroplastic recovery potential, this review establishes soft robotic exosuits as a safe, effective, and feasible paradigm shift in post-stroke gait rehabilitation that bridges the gap between traditional assistive devices and intensive task-specific neurorehabilitation. Limitations and Future Directions: Acknowledged limitations include the predominance of small pilot studies (only 3 RCTs), short-term follow-up in most studies limiting assessment of long-term retention, and lack of neurophysiological outcome measures (EEG, fMRI) linking functional recovery to neural reorganization. Future research priorities include large-scale multicenter RCTs with adequate statistical power, long-term follow-up studies (6-12 months post-intervention), dose-response investigations, neuroimaging studies exploring neural correlates of recovery, and comparative effectiveness trials determining optimal patient selection criteria and training protocols for maximizing both orthotic and therapeutic benefits.