REPLACING CANES WITH AN ELASTICATED ORTHOTIC_GARMENT IN CHRONIC STROKE PATIENTS – THE INFLUENCE ON GAIT AND BALANCE. A SERIES OF N-OF-1 TRIALS

Abstract Objective To investigate the effect of replacing canes with an elasticated orthotic-garment on balance and gait-function in chronic stroke survivors. Design Experimental, N-of-1 series with a replicated, ABC design with randomised phase duration in a home setting. Participants Four cane using chronic stroke survivors (P1-4). Interventions Phase A (9-12 weeks) cane-walking “as usual” to establish baseline values; Phase B (9-16 weeks) intervention: orthotic-garment worn throughout the day with maximal cane-use reduction; Phase C (9-10 weeks) participant-determined follow-up: either no walking-aid, orthotic-garment or cane. Outcome Measures Primary: Functional-Gait-Assessment (FGA), Secondary: Trunk-sway during walking measured as Total-Angle-Area (TAA°2) in frontal and sagittal-planes, both measured weekly. Results Visual and statistical analysis of results showed significant improvements in FGA from phase A to B in all participants. Improvement continued in phase C in P2, stabilized in P1 and P4 and deteriorated in P3. A Minimal-Clinical-Important-Difference of 6 points-change was achieved in P2 & P4. Trunk-sway reduced during walking, indicating increased stability, in two participants from phase A to B and in three participants from A to C but no TAA changes were statistically significant. In phase C participant-selected walking-aids were: P1 cane-usage reduced by 25%, P2 independent-walking with no assistive-device, S3 usual cane-usage, P4 orthotic-garment with reduced cane-usage 2-3 days-a-week, usual cane-usage 4-5 days. Conclusions Although walking ability is multifactorial these results indicate that the choice of walking-aids can have a specific and clinically relevant impact on gait following stroke. “Hands-free” assistive-devices may be more effective than canes in improving gait-function in some patients. ClinicalTrials.gov ID NCT03642444