AN AUTOMATED MOTORIZED SPLINT DELIVERING PROGRAMMED PASSIVE DORSIFLEXION AS AN ADJUNCT TO CONVENTIONAL PHYSIOTHERAPY IN FOOT DROP: A PROSPECTIVE COMPARATIVE INTERVENTIONAL STUDY

Abstract

Background. Foot drop produces loss of swing-phase toe clearance, compensatory gait deviations and a raised risk of falling. Conventional physiotherapy and static ankle–foot orthoses stabilise limb position but deliver little repetitive joint excursion, and the therapeutic dose achieved between supervised sessions is small. A motorised splint capable of delivering programmed passive dorsiflexion could raise that dose without additional therapist time. Objectives. To determine whether adding an in-house automated motorised dorsiflexion splint to conventional physiotherapy improves ankle dorsiflexion range of motion, plantarflexor tone and overground gait performance more than physiotherapy alone, and to assess device safety, comfort and usability. Methods. Fifty adults with clinically confirmed unilateral foot drop of at least one month’s duration were recruited from the orthopaedic and rehabilitation outpatient services of a tertiary teaching hospital and allocated by alternate sequential assignment to an intervention group (n = 25; motorised splint plus conventional physiotherapy) or a control group (n = 25; conventional physiotherapy alone). The splint delivered microcontroller-timed passive dorsiflexion cycles for 20–30 minutes daily, five days weekly, for 12 weeks. Primary outcomes were goniometric passive ankle dorsiflexion range of motion and the Modified Ashworth Scale; the secondary outcome was the 10 metre walk test. Comfort, satisfaction and adverse events were recorded. Results. Groups were comparable at baseline. At 12 weeks the intervention group gained 10.36° (95% CI 8.98 11.74) of dorsiflexion versus 3.31° (2.22–4.41) in controls, a between-group difference of 7.05° (5.33–8.77; p < 0.001; Cohen d = 2.33). Modified Ashworth Scale scores fell by 0.86 versus 0.31 grades (difference −0.56, −0.74 to −0.38; p < 0.001) and 10-metre walk time by 5.61 s versus 2.22 s (difference −3.40 s, −4.53 to −2.26; p < 0.001). A dorsiflexion gain of 10° or more was reached by 16 of 25 intervention patients and none of the controls (p < 0.001). Mean comfort was 8.37/10; adverse events were minor and evenly distributed (12% versus 8%, p = 1.00), with no withdrawals. Conclusion. Programmed passive dorsiflexion delivered by a low-cost motorised splint produced clinically and statistically superior gains in ankle mobility, tone and gait speed compared with physiotherapy alone over 12 weeks, with a favourable safety and tolerability profile. Confirmation in a randomised, assessor-blinded multicentre trial with instrumented gait analysis and longer follow-up is warranted.