The Feldenkrais Method for People With Intellectual Disability
Condition: Intellectual Disability
MeSH terms: Intellectual Disability
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): FELDENKRAIS METHOD (FM)
Intervention type(s): Other
Intervention description(s): They EG will receive the intervention of FM consisting of 30 lessons (1h-lesson per week; 30 weeks) verbal instructions provided by the therapist to participants. These instructions provide different options on how to perform a specific task with the purpose of leaving the decision on how to do the movement up to the performer, who has to focus on thinking, feeling, sensing and doing the movement as easily as possible.The lessons can be conducted sitting, standing or moving within a room.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be recruited at a company which provides supported employment. The primary recruitment strategy will be the information provided to the potential participants and legal guardians by the medical staff of the company. Informed consent will be obtained from the participants and their legal guardians. Afterwards they will be randomly assigned (1:1 ratio) by centre through sealedopaque envelopes to either the control or the intervention group by coin-tossing sequence generation.
It has been designed an experimental multicentre simple randomized study, with random allocation to a control group (CG) or to an experimental group (EG). This study is an open-label trial as the assessors who were experienced specialist in working with people with ID (psychologists, nurses, physicians, physiotherapists) are not blinded to group allocation.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Intellectual Disability; Feldenkrais Method; Short Physical Performance Battery; Stabilometry; Supported employment