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Table 5 Aim-specific statistical analysis plan

From: Internet-based vestibular rehabilitation versus standard care after acute onset vertigo: a study protocol for a randomized controlled trial

Analysis

Individuals analyzed

Sample size

Estimated difference based on previous results mean (SD)

Power

Method

Between group mean VSS-SF difference at w3, w6, m3, and m12

All participants

160+160

8.1 (7.4) vs 11.5 (9.9) [13]

94%

ANCOVA

Between group mean EQ-5D difference until m3

All participants

160+160

Unknown

Unknown

Mixed models

Between group mean EQ-5D difference at 12m

All participants

160+160

Unknown

Unknown

ANCOVA

Between group mean DHI difference until m3

All participants

160+160

24.4 (20.8) vs 29.2 (21.1) [13]

54%

Mixed models

Mean of means T25-FW (seconds) and timed balance tests (seconds) until m3

All participants

160+160

Unknown

Unknown

Mixed models

Between group mean difference of means of vHIT gain (affected side) at w6 and m3

Participants at sites with access to vHIT

80+80

0.52 (0.24) vs 0.69 (0.25)a [31]

99%

Ranked ANCOVA

Proportion with catch-up saccades on vHIT (affected side) at w6 and m3

Participants at sites with access to vHIT

80+80

Unknown

Unknown

Binary logistic regression

Body sway until m3

All participants

160+160

Unknown

Unknown

Mixed models

Enhanced gait and body sway analysis until m3

Umeå participants only

25+25

Unknown

Unknown

Mixed models

Total steps since last visit at w6 and m3.

All participants

160+160

Unknown

Unknown

ANCOVA

Self-reported vestibular rehabilitation compliance until

6w (mean number of training sessions)

All participants

160+160

Unknown

Unknown

Mixed models

Proportion with falls or fractures

All participants

160+160

Unknown

Unknown

Binary logistic regression

Proportion with BPPV

All participants

320

Estimated frequency 10%

N/A

Binary logistic regression

  1. Abbreviations: VSS-SF vertigo symptom scale short form, EQ-5D EuroQol five-dimension scale, DHI dizziness handicap inventory, T25-FW timed 25-foot walk test, SD standard deviation, vHIT video head impulse test, w6 6 weeks, m3 3 months, m12 12 months
  2. aPower calculations based on mean gain differences before and after vestibular rehabilitation