- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03203226
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
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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).
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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.
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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.
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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).
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Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.
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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.
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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.
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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.
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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).
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Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.
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Collaborators and Investigators
Investigators
- Principal Investigator: JON TORRES, PHD, University of the Basque Country (UPV/EHU)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M10/2015/151
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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