Upper limb robot-assisted therapy (UL-RAT) with a 3-dimensional (3D) exoskeleton significantly improves upper limb motor recovery when administered within the first month after a stroke, according to study findings published in Stroke.The multicenter randomized controlled trial evaluated the efficacy of RAT using a 3D exoskeleton to improve upper limb motor recovery in inpatients with subacute stroke and moderate-to-severe arm deficits.

Inpatients were enrolled from 8 stroke neurorehabilitation units between December 2020 and March 2024. The participants were aged 18 to 85 years and had a first-ever ischemic stroke confirmed with brain imaging. They were assigned to the robotic group, receiving UL-RAT, or the control group, which received conventional upper limb rehabilitation.

The patients were evaluated at baseline, end of treatment, and at 6 months after stroke onset. The primary outcome was the motor component of the Fugl-Meyer Assessment for Upper Limb (FM-UL), with a minimal clinically important difference (MCID) of 10.

 

These findings underscore the importance of early intensive intervention in the subacute phase and support the integration of exoskeleton-assisted therapy into rehabilitation programs…

A total of 94 patients with subacute stroke were enrolled, and 82 completed the treatment. The robotic group had 38 participants (mean age, 62 years; 31% women), and the control group had 44 participants (mean age, 63 years; 36% women). At 6 months, 49 participants were available for reassessment. A significant difference was observed in the FM-UL motor part, with higher values in the robotic group at the end of treatment (P <.001), in the between-group analysis.

Sensory score was significantly increased at the end of treatment compared with baseline in the robotic and control groups (P <.001). The joint passive range of motion did not significantly vary in the robotic group (P =.888), although it did in the control group (P =.005).

The proportion of patients who overcame the MCID of the FM score was 68.4% in the robotic group, which was more than double that occurring in the control group (31.8%), and this difference was statistically significant (P <.001). The relevant odds ratio was 4.64 (95% CI, 1.83-11.8).The interaction between time onset (≤30 and >30 days) and the participants’ severity in the robotic group compared with the control group was evaluated in a Kruskal-Wallis analysis, which did not find any statistically significant differences at baseline (P =.338) among the groups. Significant differences were found at the end of treatment (P =.008).

Limitations of the study include a relatively high dropout rate, especially at 6 months (52%), and baseline imbalances in the groups may have affected the results.

“These findings underscore the importance of early intensive intervention in the subacute phase and support the integration of exoskeleton-assisted therapy into rehabilitation programs, particularly for individuals with moderate-to-severe impairments,” the study authors concluded.