The Feldenkrais Method for People With Intellectual Disability

June 29, 2017 updated by: JON TORRES UNDA, University of the Basque Country (UPV/EHU)

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.

Study Overview

Status

Completed

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EXPERIMENTAL GROUP
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).
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.
No Intervention: CONTROL GROUP
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CHANGE FROM BASELINE PHYSICAL PERFORMANCE MEASURED BY SPPB (SCORE) AT 30 WEEKS
Time Frame: Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.
The Short Physical Performance Battery (SPPB) is a composite score of performance (0-12) based on 3 functional tasks. On each task, subjects can score between 0-4, with the higher values representing the best performance. Walking speed at a 4 m course is timed. Chair rise represented the time to complete 5 chair rises as quickly as possible. As a balance measure, standing balance score is used with responses ranging between 0-4. The sum of above mentioned three tasks provides the total SPPB score. Based on their subsequent risk for disability, mobility limitations have been characterized as being mild (score ≥10), moderate (score 7-9), and severe (score 4-6).
Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body height (cm)
Time Frame: Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.
Body height is measured (in cm) using a stadiometer (Marsden, T-226, UK) with the participant standing, wearing no shoes.
Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.
Body weight (kg)
Time Frame: Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.
Body weight is measured using a digital floor scale (Tanita, HD-314w, USA) with participants wearing light clothes and no shoes.
Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.
CHANGE FROM BASELINE STABILOMETRY (MM) (MM2) AT 30 WEEKS
Time Frame: Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.
Postural control is assessed with a static stabilometric platform (Winposture, Medicapteurs, FR) at an acquisition frequency of 50 Hz. Participants are asked to stand as still as possible with the eyes opened and bare foot during 60 sec. In order to ensure the same foot position for all the subjects, they are placed on the platform using a plastic device provided with this. Participants were instructed to look straight ahead at a mark placed onto the wall 2 m away at eye level. Data collection is initiated after participants adopted the required posture on the platform, stabilized their postural sway and signalled the experimenter that they are ready to begin. For security reasons, an assessor remains near the participant without touching or providing additional instructions during the test. Displacements of the centre of gravity are expressed in terms of sway area (mm2) and path length (mm).
Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: JON TORRES, PHD, University of the Basque Country (UPV/EHU)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 28, 2016

Study Completion (Actual)

January 30, 2017

Study Registration Dates

First Submitted

June 27, 2017

First Submitted That Met QC Criteria

June 27, 2017

First Posted (Actual)

June 29, 2017

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 29, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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