Journal of Rehabilitation Medicine 51-1CompleteIssue | Page 16

Effect of AFOs on tibialis anterior EMG the sEMG-recordings, 3D gait-analysis was recorded, using a 6-camera Vicon MX13+ motion-analysis system for capturing marker trajectories. Reflective 25-mm markers were placed directly on the skin and shoes, according to the modified Helen Hayes marker-set. Marker trajectories of the foot were used to manually determine initial contact (IC) and foot-off (FO). Marker trajectories of the left and right anterior superior iliac spine along the axis of progression were averaged and used to calculate walking speed. Data-processing was performed using custom in-house soft- ware, developed in Matlab (MathWorks, Natick, MA, USA). sEMG data were first band-pass filtered with cut-off frequencies of 25 and 450 Hz. After processing, data were manually checked for artefacts. If artefacts were found, the specific gait cycle was removed from the analysis. Subsequently, sEMG data were rectified and smoothened using a low-pass filter with cut-off frequency of 10 Hz and split into 4 sub-phases of gait using foot-events (IC and FO) of both sides: (i) first double support (DS1), from IC to opposite FO; (ii) single support (SS), from opposite FO to opposite IC; (iii) second double support (DS2), from opposite IC to FO; (iv) swing (SW), from FO to IC. Once the data were segmented into the 4 sub-phases, each sub-phase was time-normalized to 100%. These time-normalized sub- phases were used to calculate the area under the curve (AUC) to express the activity level per sub-phase. Outcome measures The primary outcome measure was TA activity during swing, as the swing phase is the main sub-phase of gait in which TA activity is shown during normal walking to evoke foot-clearance (2). The secondary outcome measure was TA activity during the other sub- phases. Outcomes were calculated for each of the 4 measurements T1–T4, with and without AFO. Walking speed without and with AFO was calculated, since walking speed is known to affect EMG (16). Statistical analysis SPSS version 19 (IBM SPSS Statistics, Chicago, IL, USA) was used for data analysis. The level of significance for all analyses was set at p < 0.05. No po- wer calculation was performed, since relevant data regarding timing of AFO provision were not available. Because TA activity per sub-phase did not show a normal distribution, logarithmic transformations were performed prior to statistical testing. Baseline data, including TA activity of both groups at T1 without AFO, were compared using independent samples t-test/Mann–Whitney U test for con- tinuous variables and χ 2 test/Fisher’s exact test for categorical variables, as appropriate. Mixed-model repeated measures analyses were performed, both within- groups to study whether AFO use affec- 13 ted TA muscle activity over a period of 26 weeks, and between- groups over time, in order to assess a group-by-time interaction. Both analyses included walking speed as a confounder. The analyses included data of all 4 measurements (T1, T2, T3, T4). Since data of 4 measurements was available only without AFO (the delayed group did not yet use an AFO at T1), the mixed- model analyses were performed for data without AFOs only. Between-group effects after 26 weeks were studied comparing the data of both groups using the independent samples t-test, both for the without and with AFO condition. The third objective was to determine whether AFO provision decreased TA muscle activity when walking with and without the AFO was compared within a single measurement session. In order to be able to compare these results with those of previous studies (mainly including subjects with chronic stroke), data of the total (early and delayed) group at T4 were included in this analysis. A paired-samples t-test was used to compare data with and without AFO. RESULTS Baseline Fig. 1 details the participant flow through the study. Thirty-three subjects (16 early, 17 delayed) were in- cluded in the study. Of these, 26 subjects (15 early, 11 Enrollment Assessed for eligibility (n=777) Randomized (n=33) Stratification on walking ability: dependent (FAC 0/1/2) (n=21) independent (FAC 3/4/5) (n=12) Early (n=16) FAC 0/1/2 (n=10), FAC 3/4/5 (n=6) Received allocated intervention (n=16) Allocated to intervention Excluded (n=744 ) - Not meeting inclusion criteria (n=734) - no stroke (n=219) - multiple strokes/stroke >6wks (n=119) - no AFO-indication (n=316) - other (n=80) - Declined to participate (n=10) Delayed (n=17) FAC 0/1/2 (n=11), FAC 3/4/5 (n=6) Received allocated intervention (n=17) AFO-provision Lost to follow-up (n=0) Missing (n=1) -no walking ability EMG-measurement (n=15) Excluded from analysis (n=1) -did not complete the study Analyzed (n=14) Measurement T1 Lost to follow-up (n=0) Missing (n=5) -no walking ability EMG-measurement (n=12) Excluded from analysis (n=5) -did not complete the study Analyzed (n=7) AFO-provision Lost to follow-up (n=1) -participation took too much effort Missing (n=0) EMG-measurement (n=15) Excluded from analysis (n=0) Analyzed (n=15) Lost to follow-up (n=0) Missing (n=1) -no lab space available EMG-measurement (n=14) Excluded from analysis (n=0) Analyzed (n=14) Lost to follow-up (n=0) Missing (n=0) EMG-measurement (n=15) Excluded from analysis (n=0) Analyzed (n=15) Measurement T2 Measurement T3 Measurement T4 Lost to follow-up (n=3) -started AFO-use too soon -started wearing high mountain shoes instead of AFO -no AFO-indication any longer Missing (n=1) -measurement not possible EMG-measurement (n=13) Excluded from analysis (n=2) -did not complete the study Analyzed (n=11) Lost to follow-up (n=2) -no suitable shoes for AFO-use provided in time -hip fracture after fall Missing (n=1) - measurement not possible EMG-measurement (n=11) Excluded from analysis (n=0) Analyzed (n=11) Lost to follow-up (n=0) Missing (n=1) - measurement not possible EMG-measurement (n=11) Excluded from analysis (n=0) Analyzed (n=11) Fig. 1. CONSORT flowchart. The figure shows the participant flow through the study. AFO: ankle- foot orthosis; FAC: Functional Ambulation Categories. J Rehabil Med 51, 2019