Table 3 Summary of planned primary, secondary and sensitivity analyses
Objective/Variable | Hypothesis | Outcome measure (type) [continuous (c), binary (b)] | Method of Analysis |
|---|---|---|---|
1) Primary | Â | Â | Â |
Walking speed at post-intervention (T2) | MLWP > BWSTT | Comfortable gait speed (c) | ANCOVA |
2) Secondary (T2, T3) | Â | Â | Â |
Secondary outcomes | Â | Â | Â |
a) Fast walking speed | MLWP > BWSTT | Fast Gait Speed (c) | ANCOVA |
b) Walking endurance | MLWP > BWSTT | Six minute walk test(c) | ANCOVA |
c) Balance and walking related self-efficacy | MLWP > BWSTT | Activities-specific Balance Confidence Scale (c) | ANCOVA |
d) Dynamic balance | MLWP > BWSTT | Functional Balance Test(c) | ANCOVA |
e) Mobility participation | MLWP > BWSTT | Life Space Questionnaire (c) | ANCOVA |
f) Health-related quality of life | MLWP > BWSTT | Stroke Impact Scale 3.0 (c) | ANCOVA |
g) Goal attainment | MLWP > BWSTT | Patient Specific Function Scale(c) | ANCOVA |
h) Walking participation | MLWP < BWSTT | Mean daily step activity | ANCOVA |
i) Training staff requirement | MLWP < BWSTT | Total number of trainers/number of training sessions (c) | T-test |
j) Meaningful change in gait speed of ≥ 0.14 m/s | MLWP > BWSTT | Comfortable gait speed change score T2-T1 ≥ 0.14 m/s)(b) | Chi-square test |
Adverse events (count) | Â | Â | Â |
a) Falls during session | Â | Therapist report (b) | Chi-square test |
b) Injury during session | Â | Therapist report (b) | Chi-square test |
c) Falls between session | Â | Patient report (b) | Chi-square test |
d) Myocardial Infarction | Â | Patient report/health record (b) | Chi-square test |
e) New stroke | Â | Patient report/health record (b) | Chi-square test |
f) Hospitalization | Â | Patient report/health record (b) | Chi-square test |
g) Death (all causes) | Â | Health record/Physician (b) | Chi-square test |
3) Sensitivity Analysis | Â | Â | Â |
a) All outcomes analysed simultaneously to account for correlation among them | Â | Primary and secondary outcomes | MANOVA |
b) Serial correlation of all outcomes at baseline, T2, T3 | Â | Primary and secondary outcomes | GEE |
c) Completers (≥ 12 sessions) | MLWP > BWSTT | Comfortable Gait speed | ANCOVA |