Page 152 - Functional impairment and cues for rehabilitation of head and neck cancer patients -

Chapter 6
MATERIALS AND METHODS
Compliance with ethical standards
This study was approved by the medical research ethics committee of the Netherlands Cancer Institute (METC18.0768/N18SEA) and was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants.
Sample size calculation
We expect an increase in T2-value from 45 ms (SD 3) to 50 ms (SD 3) based on previous research (10, 28). With three volunteers, and measuring both left and right side of the muscle (group), this provides six observations per muscle group. Although hypothesis testing was not the primary aim of the study, with this sample size, the study would have 95% power to detect this difference based on a significance level of 0.05 for each comparison, not accounting for multiple testing.
Subjects
Three healthy volunteers (one female and two males; aged 25, 26 and 29) with no known altered anatomy of the head and neck area, performed the exercises with the SEA. Likewise, three healthy volunteers performed the standard exercises (two females and one male, aged 25, 26 and 31).
SEA
The SEA, as extensively described before (18), is constructed by expanding the TheraBite Jaw Mobilization device with a chest bar (see Figure 1). By placing one or two elastic silicon ‘ActiveBands’ at various positions, external and progressive load can be obtained during the exercise regimen.
Figure 1 Swallow Exercise Aid (SEA).
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