The Feldenkrais Method for People With Intellectual Disability

Intellectual Disability Clinical Trial

Official title:

The Feldenkrais Method for Improving Functioning and Body Balance in People With Intellectual Disability: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203226
• Other study ID #: M10/2015/151
• Status: Completed
• Phase: N/A
• First received: June 27, 2017
• Last updated: June 29, 2017
• Start date: January 1, 2016
• Est. completion date: January 30, 2017

Study information

• Verified date: June 2017
• Source: Basque Country University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 30, 2017
• Est. primary completion date: December 28, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Intellectual Disability

Intervention

Other:
• FELDENKRAIS 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Basque Country University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CHANGE FROM BASELINE PHYSICAL PERFORMANCE MEASURED BY SPPB (SCORE) 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	Body height (cm)	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.
Secondary	Body weight (kg)	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.
Secondary	CHANGE FROM BASELINE STABILOMETRY (MM) (MM2) 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.