The Feldenkrais Method for People With Intellectual Disability
The Feldenkrais Method for Improving Functioning and Body Balance in People With Intellectual Disability: a Randomized Clinical Trial
Lead Sponsor: Basque Country University
|Source||Basque Country University|
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).
|Start Date||January 1, 2016|
|Completion Date||January 30, 2017|
|Primary Completion Date||December 28, 2016|
Intervention Type: Other
Intervention Name: FELDENKRAIS METHOD (FM)
Description: 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.
Arm Group Label: EXPERIMENTAL GROUP
Inclusion Criteria: - Aged between 40 and 60 years old, with mild-moderate ID and able to follow FM classes in a group Exclusion Criteria: - Aged 40 or older than 60 years old, ID not classified as mild-moderate and absence of capacity for following FM classes in a group
- Aged between 40 and 60 years old, with mild-moderate ID and able to follow FM classes in a group
- Aged 40 or older than 60 years old, ID not classified as mild-moderate and absence of capacity for following FM classes in a group
Minimum Age: 40 Years
Maximum Age: 60 Years
Healthy Volunteers: Accepts Healthy Volunteers
Type: Principal Investigator
Investigator Affiliation: Basque Country University
Investigator Full Name: JON TORRES UNDA
Investigator Title: PRINCIPAL INVESTIGATOR
|Has Expanded Access||No|
|Number Of Arms||2|
Label: EXPERIMENTAL GROUP
Description: This protocol has an unique period or phase of 30 week. Experimental group will be composed by 30 volunteer who were previously randomly assigned to this group. This group will receive a intervention based on 30 1-hour session of Feldenkrais Method (1 hour per week).
Label: CONTROL GROUP
Type: No Intervention
Description: This protocol has an unique period or phase of 30 week. Control group will be composed by 30 volunteer who were previously randomly assigned to this group. They will not receive any intervention.
|Study Design Info||
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.
Primary Purpose: Prevention
Masking: None (Open Label)