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.
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.
Authors
Tay Tay, Tam Tam, Xie Xie, Lai Lai, Yuen Yuen, Lim Lim, Ng Ng, Lim Lim, Ong Ong, Tan Tan, Rosli Rosli, Lim Lim
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