Clinical trial NCT03203226: The Feldenkrais Method for People With Intellectual Disability
Official title: The Feldenkrais Method for Improving Functioning and Body Balance in People With Intellectual Disability: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intellectual Disability
Keywords: Intellectual Disability
Feldenkrais Method
Short Physical Performance Battery
Stabilometry
Supported employment
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: CHANGE FROM BASELINE PHYSICAL PERFORMANCE MEASURED BY SPPB (SCORE) AT 30 WEEKS
timeFrame: Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.
Secondary outcomes:
measure: Body height (cm)
timeFrame: Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.
measure: Body weight (kg)
timeFrame: Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.
measure: CHANGE FROM BASELINE STABILOMETRY (MM) (MM2) AT 30 WEEKS
timeFrame: Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: University of the Basque Country (UPV/EHU)
name: JON TORRES, PHD
role: PRINCIPAL_INVESTIGATOR
References: