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

Sponsors

Lead Sponsor: Basque Country University

Source Basque Country University
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).

Overall Status Completed
Start Date January 1, 2016
Completion Date January 30, 2017
Primary Completion Date December 28, 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
CHANGE FROM BASELINE PHYSICAL PERFORMANCE MEASURED BY SPPB (SCORE) AT 30 WEEKS Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.
Secondary Outcome
Measure Time Frame
Body height (cm) Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.
Body weight (kg) Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.
CHANGE FROM BASELINE STABILOMETRY (MM) (MM2) AT 30 WEEKS Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.
Enrollment 60
Condition
Intervention

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

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

Gender: All

Minimum Age: 40 Years

Maximum Age: 60 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
JON TORRES, PHD Principal Investigator Basque Country University
Verification Date

June 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Basque Country University

Investigator Full Name: JON TORRES UNDA

Investigator Title: PRINCIPAL INVESTIGATOR

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: EXPERIMENTAL GROUP

Type: Experimental

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.

Patient Data No
Study Design Info

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.

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov