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Table 5 As-treated and per-protocol analyses of primary and secondary walking outcomes

From: Efficacy of an exoskeleton-based physical therapy program for non-ambulatory patients during subacute stroke rehabilitation: a randomized controlled trial

Variable

As-treated

Per-protocol

Exoskeleton n = 14

Usual Care n = 22

p-value

Exoskeleton n = 14

Usual Care n = 17

p-value

FAC, median (IQR)

 Baseline

0 (0–1)

0 (0–1)

 

0 (0–1)

0 (0–1)

 

 Discharge

4 (3–4)

3 (2–4)

 

4 (3–4)

3 (3–4)

 

  Change from baseline

3 (2–4)

2.5 (2–3)

0.12a

3 (2–4)

3 (2–3)

0.40a

 6-month follow-up

4.5 (4–5)

4 (2.25–4)

 

4.5 (4–5)

4 (3–5)

 

  Change from baseline

4 (3–4.75)

3 (2–4)

0.09a

4 (3–4.75)

3 (3–4)

0.40a

Gait speed, m/s, mean (SD)

 Discharge

0.47 (0.3)

0.30 (0.3)

0.15a

0.47 (0.3)

0.35 (0.3)

0.31b

 6-month follow-up

0.67 (0.5)

0.35 (0.3)

0.04a

0.67 (0.5)

0.42 (0.3)

0.10b

6MWT, m, mean (SD)

 Discharge

145.8 (110.2)

80.1 (85.0)

0.08a

145.8 (110.2)

93.0 (84.0)

0.14b

 6-month follow-up

211.2 (147.2)

103.0 (93.5)

0.03a

211.2 (147.2)

123.4 (90.1)

0.05b

Days to unassisted walkingc

24.1 (9.7)

36.7 (16.1)

0.03b

24.1 (9.7)

35.3 (15.7)

0.05b

  1. 6MWT 6-minute walk test, FAC Functional Ambulation Category, IQR interquartile range, SD standard deviation
  2. aAnalyzed using Mann–Whitney U test
  3. bAnalyzed using independent t-test
  4. cExoskeleton n = 11, Usual Care (as-treated) n = 15, Usual Care (per-protocol) n = 14
  5. Bold indicates a significant p-value < 0.05