Intellectual DisabilityNCT03203226
The Feldenkrais Method for People With Intellectual Disability
A study testing FELDENKRAIS METHOD (FM) in people with Intellectual Disability, run by University of the Basque Country (UPV/EHU).
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. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- FELDENKRAIS METHOD (FM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 40 and 60 years old, with mild-moderate ID and able to follow FM classes in a group
Who cannot join
- 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
About this study
Official title: 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.
Read the 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).
- Conditions
- Intellectual Disability
- Being tested
- FELDENKRAIS METHOD (FM)
- Keywords
- Intellectual Disability, Feldenkrais Method, Short Physical Performance Battery, Stabilometry, Supported employment
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FELDENKRAIS METHOD (FM)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL GROUP | Experimental | 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). Receives: Other: FELDENKRAIS METHOD (FM) |
| CONTROL GROUP | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.
Secondary outcomes (3)
Body height (cm)
Body height is measured (in cm) using a stadiometer (Marsden, T-226, UK) with the participant standing, wearing no shoes.
Measured: Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.
Body weight (kg)
Body weight is measured using a digital floor scale (Tanita, HD-314w, USA) with participants wearing light clothes and no shoes.
Measured: Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.
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).
Measured: Participants are assessed at baseline (1 week before the intervention) and at 30 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start1 Jan 2016
- Primary completion28 Dec 2016
- Study completion30 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Basque Country (UPV/EHU)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JON TORRES UNDA, University of the Basque Country (UPV/EHU)
- Investigators
- JON TORRES, PHD, Principal investigator, University of the Basque Country (UPV/EHU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203226
- Sponsor's protocol ID
- M10/2015/151
- Status last verified
- Jun 2017
- First submitted
- 27 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feldenkrais Method for Improving Functioning and Body Balance in People With Intellectual Disability: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03203226
- Acronym / sponsor ID
- M10/2015/151
- Conditions
- Intellectual Disability
- Keywords
- Intellectual Disability, Feldenkrais Method, Short Physical Performance Battery, Stabilometry, Supported employment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of the Basque Country (UPV/EHU)University, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 28 Dec 2016 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL GROUP | Experimental | Other: FELDENKRAIS METHOD (FM)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). |
| CONTROL GROUP | No intervention | –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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Aged between 40 and 60 years old, with mild-moderate ID and able to follow FM classes in a group
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | EXPERIMENTAL GROUP |
Primary outcome
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).
3 secondary outcomes
Body height (cm)
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JON TORRES, PHD principal investigator
University of the Basque Country (UPV/EHU)
Questions about this trial
What is this clinical trial studying?
A study testing FELDENKRAIS METHOD (FM) in people with Intellectual Disability, run by University of the Basque Country (UPV/EHU).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.