Intellectual DisabilityNCT02746614
Psychomotor Therapy Effects in Adaptive Behavior and Motor Proficiency in Intellectual Disability
A study testing Psychomotor Therapy in people with Intellectual Disability, run by Faculdade de Motricidade Humana.
Trial summary
People with intellectual and developmental disabilities (IDD) usually present limitations at adaptive behavior and motor skills, which lead to limitations/barriers in the daily independent functioning of this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- Psychomotor Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Mar 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ages above 18 years
- diagnosis of intellectual disability
- institution in Castelo Branco
Who cannot join
- other co-morbilities associated
- not institutionalised
About this study
Official title: Psychomotor Therapy Effects Adaptive Behavior and Motor Proficiency of Adults With Intellectual Disability
People with intellectual and developmental disabilities (IDD) usually present limitations at adaptive behavior and motor skills, which lead to limitations/barriers in the daily independent functioning of this population. The main goal of this research is to analyze the efficacy of a Psychomotor Intervention Program on adults with and without IDD, through an assessment of their progress both in adaptive behavior competences and motor proficiency skills.
Read the detailed description
This study sample comprised 15 participants divided by three groups of 5 individuals each: one group with IDD (with different ethiology), another one with Down Syndrome and the third with typical development. Ages range from 22 to 31 years-old (Average=26,5; St. Deviation=3,76), 6 were females and 9 males. All adults with IDD were all institutionalized at an Occupation Activities Centre of an institution and adults without ID were selected by convenience, with ages comprised within the selected range. All groups were compared through both evaluation instruments: the Portuguese version of Adaptive Behavior Scale (PABS) and Bruininks-Oseretsky Motor Proficiency Test (BOT-2). Both tests were applied according to original protocols. Ethics requisites were fulfilled. After the initial assessment, a Psychomotor Intervention Program was designed specifically for participants with IDD. This program integrated individual and group sessions during 3 months, and the main goals of the program were related to motor coordination (balance, manual dexterity and coordination, global and fine praxis), economic and professional activities, academic and verbal skills.
- Conditions
- Intellectual Disability
- Being tested
- Psychomotor Therapy
- Keywords
- adaptive behavior, motor proficiency, psychomotor therapy, intellectual disability
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychomotor TherapyOther
Psychomotor Therapy
| Study group | Role | What they receive |
|---|---|---|
| Psychomotor Therapy & Adaptive Behavior | Active comparator | After the initial assessment of adaptive behavior, i.e.., set of skills that each individual with intellectual disability should train to cope with environmental demands, a Psychomotor Intervention Program was designed specifically. The program integrated individual and group sessions during 3 months, and the main goals of the program were related to independent functioning, motor development, economic and professional activities, academic and verbal skills. Receives: Other: Psychomotor Therapy |
| Psychomotor Therapy & Motor Proficiency | Active comparator | Motor Proficiency After the initial assessment, a Psychomotor Intervention Program was designed specifically for participants with IDD. This program integrated individual and group sessions during 3 months, and the main goals of the program were related to motor coordination (balance, manual dexterity and coordination, global and fine praxis). Receives: Other: Psychomotor Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of Motor Proficiency of Bruininski-Oseretsky 2
Measured: one year
Portuguese Adaptive Behavior Scale
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startSep 2014
- Primary completionJul 2015
- Study completionMar 2016
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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Motricidade Humana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Santos, Faculdade de Motricidade Humana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746614
- Sponsor's protocol ID
- FaculdadeMH
- Status last verified
- Apr 2016
- First submitted
- 4 Apr 2016
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: All individual data were provided to institutions where the individuals were, helping in Individual Program' planning
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychomotor Therapy Effects Adaptive Behavior and Motor Proficiency of Adults With Intellectual Disability
- ClinicalTrials.gov ID
- NCT02746614
- Acronym / sponsor ID
- FaculdadeMH
- Conditions
- Intellectual Disability
- Keywords
- adaptive behavior, motor proficiency, psychomotor therapy, intellectual disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Faculdade de Motricidade HumanaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 21 Apr 2016 (estimated)
- 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.
People with intellectual and developmental disabilities (IDD) usually present limitations at adaptive behavior and motor skills, which lead to limitations/barriers in the daily independent functioning of this population. The main goal of this research is to analyze the efficacy of a Psychomotor Intervention Program on adults with and without IDD, through an assessment of their progress both in adaptive behavior competences and motor proficiency skills.
Detailed description
This study sample comprised 15 participants divided by three groups of 5 individuals each: one group with IDD (with different ethiology), another one with Down Syndrome and the third with typical development. Ages range from 22 to 31 years-old (Average=26,5; St. Deviation=3,76), 6 were females and 9 males. All adults with IDD were all institutionalized at an Occupation Activities Centre of an institution and adults without ID were selected by convenience, with ages comprised within the selected range. All groups were compared through both evaluation instruments: the Portuguese version of Adaptive Behavior Scale (PABS) and Bruininks-Oseretsky Motor Proficiency Test (BOT-2). Both tests were applied according to original protocols. Ethics requisites were fulfilled. After the initial assessment, a Psychomotor Intervention Program was designed specifically for participants with IDD. This program integrated individual and group sessions during 3 months, and the main goals of the program were related to motor coordination (balance, manual dexterity and coordination, global and fine praxis), economic and professional activities, academic and verbal skills.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychomotor Therapy & Adaptive Behavior | Active comparator | Other: Psychomotor TherapyAfter the initial assessment of adaptive behavior, i.e.., set of skills that each individual with intellectual disability should train to cope with environmental demands, a Psychomotor Intervention Program was designed specifically. The program integrated individual and group sessions during 3 months, and the main goals of the program were related to independent functioning, motor development, economic and professional activities, academic and verbal skills. |
| Psychomotor Therapy & Motor Proficiency | Active comparator | Other: Psychomotor TherapyMotor Proficiency After the initial assessment, a Psychomotor Intervention Program was designed specifically for participants with IDD. This program integrated individual and group sessions during 3 months, and the main goals of the program were related to motor coordination (balance, manual dexterity and coordination, global and fine praxis). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ages above 18 years
- diagnosis of intellectual disability
- institution in Castelo Branco
Key exclusion criteria (2 listed)
- other co-morbilities associated
- not institutionalised
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 |
|---|---|---|
| Psychomotor TherapyPsychomotor Therapy | Other | Psychomotor Therapy & Adaptive Behavior, Psychomotor Therapy & Motor Proficiency |
Primary outcome
Test of Motor Proficiency of Bruininski-Oseretsky 2
Time frame: one year
Portuguese Adaptive Behavior Scale
Time frame: one year
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 21 Apr 2016.
- Individual participant dataSharing planned: Yes. All individual data were provided to institutions where the individuals were, helping in Individual Program' planning
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Psychomotor Therapy in people with Intellectual Disability, run by Faculdade de Motricidade Humana.
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 3 inclusion and 2 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 21 Apr 2016. 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?
Test of Motor Proficiency of Bruininski-Oseretsky 2 (time frame: one year). The study lists 2 primary outcomes in all. 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 21 Apr 2016.