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The study protocol was approved by the Clinical Research Ethics Committee of the First Affiliated Hospital, Zhejiang University School of Medicine (Approval No. 2024-Research-022). All experimental procedures were performed in accordance with the principles of the Declaration of Helsinki.
Subject recruitment and screening
For this study, 20 healthy older adults (aged 60–75) were recruited from The First Affiliated Hospital, Zhejiang University School of Medicine15. Subjects were screened according to the following inclusion criteria: age 60–75 years; capability for independent walking without assistive devices; ability to walk continuously on a treadmill for ≥15 min; and MMSE score ≥24. Subjects with uncontrolled hypertension (resting BP ≥160/100 mmHg); unstable angina, severe arrhythmia, or myocardial infarction within 6 months; stroke, Parkinson’s disease, severe vertigo, or peripheral neuropathy; lower limb fracture or orthopedic surgery within 12 months; severe osteoarthritis or rheumatoid arthritis; open wounds, ulcers, dermatitis, severe varicose veins, or strap allergies at exoskeleton contact areas; BMI >30 kg/m2; or body dimensions outside the device range were excluded. Written informed consent was obtained, and baseline anthropometric metrics, including height, weight, and resting heart rate, were recorded.
Experimental setup
The treadmill was set to 3.5 km/h and 15% incline. A magnetic safety lanyard was attached from the participant’s belt to the treadmill auto-stop switch, and a supervising researcher maintained continuous access to the manual emergency stop. The exoskeleton device was prepared before testing. Battery charge level was verified to be >90%. The drive units were inspected manually to confirm the absence of cable entanglement, mechanical binding, or excessive friction in the transmission mechanisms. The exoskeleton provided terrain-adaptive assistance modes (Climbing, Downhill, Flat) with 5 intensity levels (up to 18 Nm). Climbing Mode incorporated a gait-learning algorithm and an angle-triggered mechanism (0–90° range) to synchronize hip flexion torque with the wearer’s gait phase. Assistance magnitude, predominantly at levels 3 or 4, was personalized based on subjective tolerance during adaptation. Subjects were fitted with a heart rate monitor for continuous data recording. The Borg RPE scale (6–20) and VAS pain scale (0–10) were printed on A4 paper and positioned within the participant’s clear line of sight to ensure immediate accessibility during testing.
Device donning and fitting (Unblinded phase)
An appropriate device size was selected based on participant height (Size L for height >165 cm; Size M for height ≤165 cm). Subjects were assisted in donning the shoulder straps, and the back module height was adjusted to coaxially align the lateral hip motor units with the greater trochanter. The magnetic waist buckle was fastened, and the lateral adjustment straps were tightened above the iliac crest to anchor the device securely to the pelvis and prevent slippage during actuation. Leg connections were secured. Thigh struts were aligned approximately 5–10 cm above the patella. Hooks were secured, and the Boa dial was rotated clockwise to tighten the thigh straps. Strap tension was verified by maintaining approximately 1.0–1.5 cm clearance between the strap and the skin when pulled perpendicular to the skin. Subjects performed squats and high leg lifts to verify the absence of mechanical interference or excessive cable tension (Figure 1). A 15-min adaptation session16 was conducted. Subjects walked without the device on the treadmill at 3.5 km/h and 15% incline for 5 min. Subjects walked with the unpowered exoskeleton (EXO_OFF) for 5 min. Subjects walked with the powered exoskeleton (EXO_ON) for 5 min while assistance intensity was gradually increased from level 1 to the subject’s comfort level (levels 3 or 4). Subjects then rested in a seated position for 20 min before the formal trials. The 20-min rest period ensured that heart rate and perceived exertion returned to baseline levels17.
Intervention and blinding
The order of the three experimental conditions was randomized using a computer-generated sequence to minimize learning and fatigue effects. In the NO_EXO condition, subjects walked in standard sportswear without the exoskeleton. In the EXO_ON condition, the device was activated in Climbing Mode with assist intensity set to level 3 or 4. The exact assistance level was determined by verifying a stable gait rhythm without visible postural instability, compensatory movements, or reported resistance to the device torque. All LED indicators (power and mode lights) were covered with black electrical tape in both EXO_ON and EXO_OFF conditions to maintain visual blinding. A 40-min seated rest period was provided between trials to allow heart rate and fatigue levels to return to baseline.
Simulated uphill walking task (Blinded assessment)
Subjects walked on the treadmill for 15 min and were encouraged to maintain natural walking without holding the handrails unless necessary for safety. Heart rate (HR) was continuously recorded. The 180 heart rate data points collected from min 12:00–15:00 at a sampling rate of 1 Hz were averaged to calculate the steady-state heart rate. The absolute highest heart rate recorded during the task was defined as HR_Peak. At min 14, subjects reported their level of exertion using the Borg RPE scale. Immediately after task completion (within 1 min), the VAS scale was used to assess skin integrity and joint pain. Skin contact areas were visually inspected for erythema, blisters, or pressure marks. Joint pain was recorded using a 0–10 cm VAS scale, where 0 indicated no pain, and 10 indicated the worst imaginable pain. Scores ≥4 were considered clinically significant discomfort requiring further evaluation. The Physiological Cost Index (PCI) was calculated using the formula adapted from MacGregor18: PCI = (Walking Heart Rate − Resting Heart Rate) / Walking Speed, expressed in beats per minute per kilometer per hour (beats/min/km/h).
Statistical analysis
Outcome variables were compared across conditions using ANOVA, with effect sizes reported as partial eta-squared (η2p). Post hoc pairwise comparisons used Bonferroni-corrected paired t-tests, and Cohen's dz with 95% CIs were calculated (Supplementary Table 1). Condition order was counterbalanced, with rest periods between trials to minimize carryover effects. Significance was set at p < 0.05.