Intellectual Disability
Conditions
Keywords
Intellectual Disability, Feldenkrais Method, Short Physical Performance Battery, Stabilometry, Supported employment
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).
Interventions
OTHERFELDENKRAIS METHOD (FM)
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.
Sponsors
University of the Basque Country (UPV/EHU)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body height (cm) | 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. |
| Body weight (kg) | 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. |
| CHANGE FROM BASELINE STABILOMETRY (MM) (MM2) AT 30 WEEKS | 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). |
Outcome results
None listed