JMIR Publications

ABSTRACT

Background:

Knee exoskeletons represent a significant advancement in wearable robotic technology, developed to enhance gait assistance and facilitate rehabilitation processes. These devices are increasingly employed in clinical and research environments worldwide. Nonetheless, the existing empirical evidence that substantiates their biomechanical and functional outcomes lacks comprehensive breadth and clarity. Further investigation is essential to elucidate the specific effects of knee exoskeletons on gait dynamics and rehabilitation efficacy.

Objective:

To systematically review the clinical and biomechanical evidence on knee exoskeletons used for gait assistance and rehabilitation.

Methods:

A systematic search of databases including PubMed, Web of Science, IEEE Xplore, and Scopus was conducted to identify eligible studies published between January 2015 and March 2025. Studies were included if they investigated knee exoskeleton systems in human participants for gait assistance and rehabilitation. Randomized Controlled Trials, Observational studies, and Experimental investigations were eligible. Exclusion criteria were multi-joint exoskeletons, non-human studies, and simulation-based analyses. Two reviewers independently extracted study characteristics, participant demographics, device features, intervention protocols, and clinical and biomechanical outcomes. Risk of bias was assessed using RoB-2 for randomized controlled trials and ROBINS-I for non-randomized studies.

Results:

Thirty-two studies met the inclusion criteria. Most investigations involved healthy adults in feasibility or pilot settings, while a smaller subset included individuals with stroke, spinal cord injury, or orthopedic conditions or pediatric movement disorders. Across studies, knee exoskeletons demonstrated short-term improvements in spatiotemporal gait parameters, knee joint kinematics, and metabolic efficiency. However, substantial heterogeneity in device design, outcome metrics, and intervention duration leads to limited comparability across studies. Sample sizes were typically small, and follow-up outcomes were rarely reported, restricting the interpretation of the long-term clinical efficacy of these devices.

Conclusions:

Knee exoskeletons demonstrate promising short-term functional and biomechanical benefits and are increasingly feasible within structured rehabilitation settings. While current evidence is limited by small sample sizes and brief follow-up, emerging data suggests the potential to enhance task-specific gait training. Larger, well-designed trials are needed to determine sustained clinical impact and integration into routine rehabilitation practice. Clinical Trial: This systematic review was registered in PROSPERO (CRD420261285256)