Efficacy of a soft robotic exoskeleton for upper-limb rehabilitation in subacute stroke inpatient rehabilitation: a randomised controlled trial

Soft robotic devices may be a useful adjunct for stroke rehabilitation by providing higher intensity training, while allowing comfort and portability compared to rigid exoskeletons. We evaluated the efficacy of a sensor-assisted soft robotic glove (SSR) during inpatient stroke rehabilitation. This assessor-blinded, randomised controlled trial was conducted in 2 inpatient rehabilitation units. Adults aged 21–90 years old, with ischaemic or haemorrhagic stroke and unilateral upper-limb impairment were recruited between July 2023 and May 2025. Participants were randomised to either [1] SSR or [2] supervised Graded Repetitive Arm Supplementary Programme (GRASP) training for up to 15 sessions, 30–45 min/session; 5 days/week for up to 3 weeks. The primary outcome was Fugl-Meyer Assessment of Upper Extremity (FMA-UE). Secondary outcomes included Stroke Upper Limb Capacity Scale, the DuruÖz Hand Index, and Stroke Impact Scale-16 (SIS-16). Outcomes were assessed at baseline (T1), post-intervention (T2) and follow-up at 3 months (T3). Recruitment ceased before the planned sample size was reached due to funding constraints. Therefore, the trial was underpowered to detect the prespecified between-group difference. Of 323 screened individuals, 61 were randomised. 3 participants did not complete T2 assessment resulting in a modified intention-to-treat population of 58 (SSR n = 28, control n = 30). Both groups showed improvement across primary and secondary outcomes, with no statistically significant differences observed between them. In a post-hoc exploratory subgroup analysis with baseline FMA-UE < 35 and ≥ 10 sessions ( n = 38), a statistically significant difference in FMA-UE distal sub-score at T2 was observed, favouring the SSR group (mean difference 3.06, 95% confidence interval [CI] 0.02 to 6.09, p = 0.049) but not at T3. A numerically higher proportion of participants in the SSR group achieved minimal clinically important difference value for SIS-16 (77.8% vs. 55.0%, adjusted odds ratio 6.52 (95% CI 1.00 to 42.58, absolute risk difference 22.8% [95% CI -7.2% to 47.4%], p = 0.050) at T2, but did not reach statistical significance. Sensor-assisted soft robotic glove training did not demonstrate superiority over supervised GRASP for upper limb function post-stroke. Exploratory subgroup analyses identified a signal suggesting improved distal hand motor recovery in participants with greater baseline impairment with sufficient therapy exposure.