Table 2A.
Observed mean values and estimated differences and 95% confidence intervals for balance primary and secondary outcome measures
RAS-supported | Regular | Control | RAS-supported vs Regular | RAS-supported vs Control | Regular vs Control | ||
1 | 2 | 3 | 1-2 | 1-3 | 2-3 | ||
Mini BESTest | Baseline | 14.8 (12.9; 16.6) | 17.3 (14.9; 19.7) | 15.1 (12.4; 17.7) | |||
Post Intervention | 21.9 (21.0; 22.7) | 18.3 (17.3; 19.2) | 15.2 (14.2; 16.3) | 3.5 (2.2; 4.8), P < 0.001 | 6.6 (5.2; 8.0), P < 0.001 | 3.0 (2.7;5.3), P < 0.001 | |
1 month Follow-up | 21.1 (20.2; 22.0) | 17.0 (16.1; 18.0) | 15.0 (13.9; 16.0) | 4.0 (2.7; 5.3), P < 0.001 | 6.0 (4.7; 7.4) P < 0.001 | 2.0 (0.6; 3.4), P = 0.005 | |
6 month Follow-up | 19.6 (18.7; 20.4) | 15.8 (14.8; 16.7) | 14.7 (13.2; 15.7) | 3.7 (2.4; 5.1), P < 0.001 | 4.8 (3.4; 6.2) P < 0.001 | 1.0 (–0.3;2.4), P = 0.136 | |
Berg Balance Scale | Baseline | 38.9 (35.6; 42.3) | 40.9 (37.0; 44.9) | 37.5 (33.0; 41.9) | |||
Post Intervention | 47.0 (44.7; 48.4) | 41.7 (40.3; 43.2) | 38.3 (36.7; 39.92) | 5.2 (3.2; 7.3), P < 0.001 | 8.6 (6.; 10.8), P < 0.001 | 3.4 (1.2; 5.6), P = 0.002 | |
1 month Follow-up | 45.6 (44.2; 46.9) | 40.3 (38.8; 41.8) | 37.8 (36.1; 39.4) | 5.2 (3.2; 7.3), P < 0.001 | 7.8 (5.6; 9.4), P < 0.001 | 2.5 (0.3; 4.7), P = 0.024 | |
6 month Follow-up | 43.1 (41.7; 44.5) | 38.9 (37.5; 40.4) | 37.1 (35.5; 38.7) | 4.1 (2.1; 6.2), P < 0.001 | 6.0 (3.8; 8.1), P < 0.001 | 1.8 (–0.3; 4.0), P = 0.098 | |
Retropulsion Test | Baseline | 2.3 (1.9; 2.7) | 2.1 (1.7; 2.4) | 2.4 (2.3; 2.8) | |||
Post Intervention | 1.0 (0.9; 1.2) | 1.3 (1.0; 1.5) | 2.2 (2.0; 2.4) | –0.2 (–0.5; 0.0), P = 0.164 | –1.1 (–1.4; –0.8), P < 0.001 | –0.9 (–1.3; –0.6), P < 0.001 | |
1 month Follow-up | 1.2 (1.0; 1.4) | 1.8 (1.6; 2.1) | 2.3 (2.1; 2.6) | –0.6 (–0.9; –0.3), P < 0.001 | –1.1 (–1.4; –0.8), P < 0.001 | –0.5 (–0.8; –0.1), P = 0.002 | |
6 month Follow-up | 1.7 (1.5; 1.9) | 2.1 (1.9; 2.3) | 2.4 (2.1; 2.6) | –0.3 (–0.6; –0.0), P = 0.011 | –0.6 (–0.9; –0.3), P < 0.001 | –0.3 (–0.6; 0.0), P = 0.070 | |
Push and Release Test | Baseline | 2.4 (2.0; 2.7) | 2.1 (1.8; 2.5) | 2.4 (2.0; 2.8) | |||
Post Intervention | 1.1 (0.9; 1.2) | 1.4 (1.2; 1.5) | 2.3 (2.1; 2.5) | –0.3 (–0.5; –0.4), P = 0.020 | –1.2 (–1.4; –0.9), P < 0.001 | –0.9 (–1.1; –0,6), P < 0.001 | |
1 month Follow-up | 1.4 (1.2; 1.5) | 2.0 (1.8; 2.1) | 2.4 (2.2; 2.6) | –0.6 (–0.8; –0.3), P < 0.001 | –1.0 (–1.2; –0.7), P < 0.001 | –0.4 (–0.7; –0.1), P = 0.001 | |
6 month Follow-up | 1.9 (1.7; 2.0) | 2.1 (2.0; 2.4) | 2.5 (2.3; 2.7) | –0.3 (–0.6; –0.1), P = 0.003 | –0.6 (–0.9; –0.3), P < 0.001 | –0.2 (–0.5; 0.0), P = 0.049 | |
Falls Efficacy Scale - International | Baseline | 31.5 (26.8; 36.2) | 34.3 (30.0; 38.4) | 36.2 (31.0; 41.4) | |||
Post Intervention | 27.8 (22.0; 29.3) | 31.4 (29.9; 32.9) | 36.2 (31.9; 35.3) | –3.6 (–5.7; –1.5), P = 0.001 | –5.7 (–8.0; –3.5), P < 0.001 | –2.1 (–4.4; –0.1), P = 0.062 | |
1 month Follow-up | 27.8 (22.1; 29.3) | 32.9 (31.4; 34.4) | 36.5 (32.4; 35.6) | –5.0 (–7.1; –2.9), P < 0.001 | –6.0 (–8.3; –3.8), P < 0.001 | –0.9 (–3.2; 1.3), P = 0.394 | |
6 month Follow-up | 30.0 (23.9; 31.7) | 33.6 (32.1; 35.2) | 38.7 (33.8; 37.2) | –3.6 (–5.7; –1.5), P < 0.001 | –5.5 (–7.7; –3.2), P < 0.001 | –1.8 (–4.1; –0.4), P = 0.113 |
Group: Multimodal balance training supported by rhythmical auditory stimuli (RAS-supported), Multimodal balance training without rhythmical auditory stimuli (Regular), Control Intervention group (Control). Confidence Intervals (CI) – Adjusted Mean Difference (95% CI) Between Baseline and 35-week). Primary analysis: Adjusted for baseline MBEST score; Secondary analyses: also adjusted for baseline LEDD, baseline UPDRS 2 and 3. Mini BESTest – 14 items, total 28 of points, scored 0–2 (higher score better balance). Berg Balance Scale - 14 items total 56 of points, scored 0–4 points (higher score better balance). Retropulsion test and Push-and-release test scored between 1–4 points, lower score means better balance. Falls Efficacy Scale International – 16 items, total 64 of points scored), higher scores greater fear of fallen.