Intellectual Disability Clinical Trial
Official title:
The Feldenkrais Method for Improving Functioning and Body Balance in People With Intellectual Disability: a Randomized Clinical Trial
Loss of functioning and age-related health problems tend to appear earlier in individuals with intellectual disability (ID) than in their non-disabled peers and due to this people with ID who are in employment tend to need to retire earlier, producing social, economic and health problems. The Feldenkrais method (FM) is a movement-based form of learning that enhances body balance and physical functioning. We hypothesized that the FM could be helpful to improve balance and functioning of employed people with ID.
The aim of this study will be to determine the effects of a Feldenkraisn Method (FM) program
in improving functionality and body balance in supported employed individuals with ID. To
evaluate this effect, a total of subjects will participate in a longitudinal and clinical
trial.
Sample size has been calculated to detect minimal significant effects on the variable of
physical performance (SPPB): accepting an alpha risk of 0.05 and a beta risk of 0.20 in a
bilateral contrast, 26 individuals are required in order to detect a difference equal to or
greater than 1.5 unit in the SPPB (SD= 1.94). It has been increased the sample size in an
additional 20% (losts during follow-up) and 5% (mortality). The resultant sample size is
determinate in 32 individuals, who are equally randomized in both experimental and control
groups.
Statistical analysis was performed using IBM SPSS Statistics for Windows (Version 22.0). Data
were presented as mean ± standard deviation. Descriptive statistics were calculated for all
outcome measures. Mean differences within the groups in the functional tests and
stabilometric outcomes were estimated using paired sample t-tests, while mean differences
between the groups in these variables were estimated using repeated measures analysis of
variance. Differences were considered significant at p < 0.05. To determine the magnitude of
the interactions between time and group, the effect size or µ2 was calculated as described by
Cohen (1998) and interpreted as small (> 0.01 and < 0.06), moderate (≥ 0.06 and < 0.14) or
large (≥ 0.14).
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