Effects of wearable lower-limb robotic exoskeleton–assisted gait training on balance, walking, and activities of daily living after stroke: a systematic review and meta-analysis

Abstract

Wearable lower-limb robotic exoskeleton–assisted gait training encompasses heterogeneous overground and treadmill/platform-based implementations. Comparative effects remain uncertain. We synthesised evidence from randomised controlled trials (RCTs) on walking, balance, lower-limb motor function, and activities of daily living (ADL). We searched PubMed, Embase, the Cochrane Central Register of Controlled Trials, Web of Science Core Collection, and China National Knowledge Infrastructure from inception to February 26, 2026. We included RCTs comparing wearable lower-limb robotic exoskeleton–assisted gait training (overground and/or treadmill/platform-based) with usual rehabilitation or other controls. Effects were pooled using random-effects models with restricted maximum likelihood estimation and Hartung–Knapp adjustment; 95% prediction intervals were reported when applicable. Certainty was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach, and publication bias was evaluated for outcomes with ≥10 studies. Fourteen RCTs ( n = 565) were included. Pooled between-group estimates favoured intervention groups for walking independence measured by the Functional Ambulation Category (FAC; mean difference [MD] = 0.39, 95% confidence interval [CI] 0.15–0.63), balance measured by the Berg Balance Scale (BBS; MD = 1.66, 95% CI 0.52–2.81), and lower-limb motor function measured by the Fugl–Meyer Assessment of the Lower Extremity (FMA-LE; MD = 2.40, 95% CI 1.63–3.16). The 6-Minute Walk Test estimate favoured intervention groups (MD = 19.83, 95% CI 2.21–37.45), although its prediction interval crossed the null. No between-group differences emerged for walking speed, mobility, or ADL. Certainty was moderate for FAC, BBS, and FMA-LE and low to very low for other outcomes. No small-study effects were detected for BBS (k = 11; p > 0.05). Across heterogeneous exoskeleton-assisted gait-training interventions, pooled estimates favoured intervention groups for walking independence, balance, and lower-limb motor function. However, most prediction intervals crossed the null, certainty for other outcomes was low to very low, and inconsistent reporting limited analyses of training environment and precluded granular analyses of body-weight support, assistance strategy, patient engagement, comparator content, dose, and patient selection. These estimates reflect heterogeneous intervention–comparator packages and cannot determine whether differences are attributable to the robotic device category itself or support specific prescribing recommendations. Larger, stratified RCTs with standardised reporting and longer follow-up are needed to identify influential intervention and patient characteristics. https://www.crd.york.ac.uk/PROSPERO/view/CRD420261327255