Intellectual Disability, MildNCT06120686
Biofeedback Training's Impact on Cognitive and Motor Skills in Kids With Intellectual Disabilities
A study testing Biofeedback method and Conventional therapy program in people with Intellectual Disability, Mild, run by Aleksandra Kiper at 1 site in Poland.
Trial summary
The expected outcome of the study is to confirm or reject the hypothesis that traditional rehabilitation in combined with biofeedback training produces better results in improving motor and cognitive functions, relative to conventional rehabilitation. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Intellectual Disability, Mild
- What is being tested?
- Biofeedback method and Conventional therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2023to Jan 2025
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosed mild intellectual disability,
- age 7-12 years,
- current health status allowing the child to participate in the study and participate in the rehabilitation program,
- informed voluntary consent of parents and/or legal guardians to participate in the study.
Who cannot join
- diagnosed intellectual disability of severe and profound degree,
- cognitive deficits impairing the ability to understand and follow instructions,
- age below 7 or above 12 years,
- coexistence of autism, Down syndrome, cerebral palsy, muscular dystrophy and neurological disorders, such as epilepsy or brain damage,
- the presence of comorbidities such as rheumatic, orthopedic, oncological or cardiac diseases that may affect the subject's motor impairment.
- the lack of informed voluntary consent from parents and/or legal guardians to participate in the study.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
University of Rzeszów
Rzeszów, 35-959
Aleksandra Ewa Kiper, MSc, +48607974712, akiper94@gmail.com
About this study
Official title: Effect of Biofeedback Training on Cognitive and Motor Functions in Children With Intellectual Disabilities
The expected outcome of the study is to confirm or reject the hypothesis that traditional rehabilitation in combined with biofeedback training produces better results in improving motor and cognitive functions, relative to conventional rehabilitation.
In addition, the result of the study will be a protocol for dealing with school-aged children school-age children with impaired motor functions associated with impaired cognitive functions.
The developed material, will be a practical addition to therapeutic programs, Particularly useful in the work of psychological and pedagogical clinics, in offices of rehabilitation and sensory integration offices, or centers implementing early childhood development supporting child development.
Read the detailed description
In accordance with the study design, children with intellectual disabilities who will participate in a 3-week rehabilitation program will be eligible for the study.
The research will be a single-center study. The research will be conducted at the St. Hedwig the Queen Regional Hospital No. 2, Lwowska 60, 35-301 Rzeszów - Department of Child Neurology and Pediatrics.
Number of subjects included in the study: The planned group size is 60 people (30 people - study group, 30 people - control group). The given population was calculated on the basis of the sampling calculator " PLUS module " Statistica 13.3 software, taking into account the following parameters: fraction size, confidence level, maximum error.
For the study of the effect of biofeedback training on cognitive and motor function in children with intellectual disabilities, there is no need to recruit healthy participants to the control group.
Prior to the actual study, a pilot study will be conducted on a smaller group of test subjects. After taking into account the eligibility criteria, the subjects will be assigned, on the basis of random selection random assignment, to two groups: the study group - implementing the conventional therapy program supplemented additionally with visual and auditory biofeedback training on a dynamic balance platform, the control - implementing only the conventional therapy program.
Respondents from both groups will participate in a 3-week therapy program, under the same conditions using the same measuring instruments. All participants will be informed about the purpose and conduct of the study and, after consenting to the study, will be qualified for the study proper. The participation of the child called "Minor" in this study depends solely on the parent or legal guardian's expression of consent by signing the Informed Consent Form after reading the information presented information about the study being conducted.
The examination will be performed twice, the initial one before the start of therapy, and the control one after the 3-week rehabilitation program has been completed. The following tools will be used to evaluate the effects of rehabilitation: AMTI dynamography platform, Romberg Test, Up and Go Test - assessment of static and dynanmic balance, ZEBRIS computer system - assessment of posture, HEG Biofeedback (hemoencephalography) - assessment of concentration and attention, AVLT (AuditoryVerbal Lerning Test), Bourdon-Wiersma Test - assessment of cognitive functions, Southern California Sensory Integration Test - assessment of sensory function, Box and Block Test, dynamometer - assessment of hand function, Eurofit Special Test - assessment of physical fitness, PedsQLTM Pediatric Quality of Life Questionnaire - assessment of quality of life, Barthel Scale - assessment of functional ability.
The examination time for one participant will be 1.5 hours. A period of 12 months is planned for recruitment and examination of participants.
The planned study does not involve any risks and possible health hazards for the participants examination. The conducted examination will be completely painless and non-invasive with dignity and principles of intimacy for each patient. The examination will be conducted using measuring devices certified and approved for use within the framework of scientific research in the field of rehabilitation.
The expected outcome of the study is to confirm or reject the hypothesis that traditional rehabilitation combined with biofeedback training produces better results in improving motor and cognitive functions, compared to conventional rehabilitation.
Description of benefits to study participants:
Improved motor and cognitive functions of children with intellectual disabilities, protocol rehabilitation management for children with intellectual disabilities.
- Conditions
- Intellectual Disability, Mild
- Being tested
- Biofeedback method, Conventional therapy program
- Keywords
- intellectual disability, cognitive function, motor function, training, rehabilitation, biofeedback
- Medical subject headings
- Intellectual Disability, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback methodOther
Also called Conventional therapy program
Study group - implementing a conventional therapy program supplemented additionally with visual and auditory biofeedback training on a dynamic balance platform
Conventional therapy programOther
Control group - rehabilitation management aimed at improving cognitive and motor functions in children with mild intellectual disabilities.
| Study group | Role | What they receive |
|---|---|---|
| biofeedback-based therapy (BBT) | Experimental | study group - implementing the conventional therapy program supplemented additionally by training with visual and auditory biofeedback on a dynamic balance platform Receives: Other: Biofeedback method; Other: Conventional therapy program |
| conventional therapy program (CT) | Other | control group - implementing only the conventional therapy program Receives: Other: Conventional therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of static and dynamic balance using the AMTI platform
AMTI platform use is to assess balance ability.
Measured: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program.
Posture assessment using the computer-based ZEBRIS system
Zebris device allows non-invasive assessment of the shape of the curvature of the spine and parameters that determine postural disorders. The ZEBRIS system consists of a measuring unit, a system of micro-sensors and an ultrasonic pointer, with which topographic points are scanned from the skeleton and then processed in a computer program in the form of a report containing numerical data specifying lengths, angles and degrees for each parameter, as well as graphs and figures of the spinal line.
Measured: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program.
Assessment of concentration and attention with HEG Biofeedback (hemoencephalography)
Hemoencephalography (HEG) is a method of monitoring changes in frontal cerebral blood circulation and oxygenation. HEG biofeedback is a method based on the use of near-infrared technology to measure cerebral hemodynamics.
A sensor armband is placed on the head in the area where reduced blood oxygenation is noted, and then emits into the brain, two beams of light at different frequencies. This allows us to check the oxygen saturation in a particular area of the brain in real time. The signal is returned to the computer screen, and the trainer tries to increase it. HEG biofeedback training involves stimulating neurons in the frontal lobes of the brain.
Measured: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program.
Secondary outcomes (11)
Assessment of functional by Barthel Scale
Based on the scores assigned the patient's condition is described in the following way: I. 86-100 points - "slight" dependency; II. 21- 85 points - "moderately severe" dependency; III. 0 - 20 points - "severe" dependency.
ability
Measured: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program.
Quality of life assessment using the PedsQLTM Pediatric Quality of Life Questionnaire
The PedsQL is based on a modular approach to measuring health-related quality of life and consists of a 15-item core measure of global health-related quality of life .
Measured: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
Assessment of cognitive function using the AVLT test
Involves five sequential presentations of a 15-word list.
Measured: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
Assessment of cognitive function using the Bourdon-Wiersma test
The Bourdon test is an approach to measuring focus and attention that requires the test taker to detect and cross out specific characters in a set of letters.
Measured: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
Manual skills, assessed with Box and Blocks test
The test uses a wooden box, divided into two equal parts by a partition, as well as 150 blocks. The subject moves as many blocks as possible from one part of the box to the other during 60 seconds.
Measured: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
Romberg test
The Romberg test is used to assess static balance. The test involves standing with your feet together and your arms at your side or crossed in front of you. Part of the test is with your eyes open, and the second part is with your eyes closed.
Measured: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
TUG test
In the TUG test subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again.
Measured: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
Southern California Sensory Integration Test - Bilateral Motor Coordination
This test gives information about the motor activity of both sides of the body, sense of rhythm and sequence.
Measured: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
Southern California Sensory Integration Test - Crossing the Body's Midline
This test gives information about the rate and quality of cooperation between the brain hemispheres.
Measured: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
Southern California Sensory Integration Test - Graphesthesia
This test gives information about the ability to visualize tactile stimuli from the top of the hand area and visuomotor coordination.
Measured: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
Southern California Sensory Integration Test - Differentiating Right from Left
This test gives information about distinguishing the sides of the body.
Measured: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study startNov 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual Disability, MildStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- random selection to two groups (study group and control group)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aleksandra Kiper
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aleksandra Kiper, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120686
- Sponsor's protocol ID
- 2023/07/48
- Status last verified
- Nov 2023
- First submitted
- 14 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Biofeedback Training on Cognitive and Motor Functions in Children With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT06120686
- Acronym / sponsor ID
- 2023/07/48
- Conditions
- Intellectual Disability, Mild
- Keywords
- intellectual disability, cognitive function, motor function, training, rehabilitation, biofeedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aleksandra KiperUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 7 Nov 2023 (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.
The expected outcome of the study is to confirm or reject the hypothesis that traditional rehabilitation in combined with biofeedback training produces better results in improving motor and cognitive functions, relative to conventional rehabilitation.
In addition, the result of the study will be a protocol for dealing with school-aged children school-age children with impaired motor functions associated with impaired cognitive functions.
The developed material, will be a practical addition to therapeutic programs, Particularly useful in the work of psychological and pedagogical clinics, in offices of rehabilitation and sensory integration offices, or centers implementing early childhood development supporting child development.
Detailed description
In accordance with the study design, children with intellectual disabilities who will participate in a 3-week rehabilitation program will be eligible for the study.
The research will be a single-center study. The research will be conducted at the St. Hedwig the Queen Regional Hospital No. 2, Lwowska 60, 35-301 Rzeszów - Department of Child Neurology and Pediatrics.
Number of subjects included in the study: The planned group size is 60 people (30 people - study group, 30 people - control group). The given population was calculated on the basis of the sampling calculator " PLUS module " Statistica 13.3 software, taking into account the following parameters: fraction size, confidence level, maximum error.
For the study of the effect of biofeedback training on cognitive and motor function in children with intellectual disabilities, there is no need to recruit healthy participants to the control group.
Prior to the actual study, a pilot study will be conducted on a smaller group of test subjects. After taking into account the eligibility criteria, the subjects will be assigned, on the basis of random selection random assignment, to two groups: the study group - implementing the conventional therapy program supplemented additionally with visual and auditory biofeedback training on a dynamic balance platform, the control - implementing only the conventional therapy program.
Respondents from both groups will participate in a 3-week therapy program, under the same conditions using the same measuring instruments. All participants will be informed about the purpose and conduct of the study and, after consenting to the study, will be qualified for the study proper. The participation of the child called "Minor" in this study depends solely on the parent or legal guardian's expression of consent by signing the Informed Consent Form after reading the information presented information about the study being conducted.
The examination will be performed twice, the initial one before the start of therapy, and the control one after the 3-week rehabilitation program has been completed. The following tools will be used to evaluate the effects of rehabilitation: AMTI dynamography platform, Romberg Test, Up and Go Test - assessment of static and dynanmic balance, ZEBRIS computer system - assessment of posture, HEG Biofeedback (hemoencephalography) - assessment of concentration and attention, AVLT (AuditoryVerbal Lerning Test), Bourdon-Wiersma Test - assessment of cognitive functions, Southern California Sensory Integration Test - assessment of sensory function, Box and Block Test, dynamometer - assessment of hand function, Eurofit Special Test - assessment of physical fitness, PedsQLTM Pediatric Quality of Life Questionnaire - assessment of quality of life, Barthel Scale - assessment of functional ability.
The examination time for one participant will be 1.5 hours. A period of 12 months is planned for recruitment and examination of participants.
The planned study does not involve any risks and possible health hazards for the participants examination. The conducted examination will be completely painless and non-invasive with dignity and principles of intimacy for each patient. The examination will be conducted using measuring devices certified and approved for use within the framework of scientific research in the field of rehabilitation.
The expected outcome of the study is to confirm or reject the hypothesis that traditional rehabilitation combined with biofeedback training produces better results in improving motor and cognitive functions, compared to conventional rehabilitation.
Description of benefits to study participants:
Improved motor and cognitive functions of children with intellectual disabilities, protocol rehabilitation management for children with intellectual disabilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- random selection to two groups (study group and control group)
| Arm | Type | Receives |
|---|---|---|
| biofeedback-based therapy (BBT) | Experimental | Other: Biofeedback method, Other: Conventional therapy programstudy group - implementing the conventional therapy program supplemented additionally by training with visual and auditory biofeedback on a dynamic balance platform |
| conventional therapy program (CT) | Other | Other: Conventional therapy programcontrol group - implementing only the conventional therapy program |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- diagnosed mild intellectual disability,
- age 7-12 years,
- current health status allowing the child to participate in the study and participate in the rehabilitation program,
- informed voluntary consent of parents and/or legal guardians to participate in the study.
Key exclusion criteria (6 listed)
- diagnosed intellectual disability of severe and profound degree,
- cognitive deficits impairing the ability to understand and follow instructions,
- age below 7 or above 12 years,
- coexistence of autism, Down syndrome, cerebral palsy, muscular dystrophy and neurological disorders, such as epilepsy or brain damage,
- the presence of comorbidities such as rheumatic, orthopedic, oncological or cardiac diseases that may affect the subject's motor impairment.
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 |
|---|---|---|
| Biofeedback methodAlso: Conventional therapy programStudy group - implementing a conventional therapy program supplemented additionally with visual and auditory biofeedback training on a dynamic balance platform | Other | biofeedback-based therapy (BBT) |
| Conventional therapy programControl group - rehabilitation management aimed at improving cognitive and motor functions in children with mild intellectual disabilities. | Other | biofeedback-based therapy (BBT), conventional therapy program (CT) |
Primary outcome
Assessment of static and dynamic balance using the AMTI platform
Time frame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program.
AMTI platform use is to assess balance ability.
Posture assessment using the computer-based ZEBRIS system
Time frame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program.
Zebris device allows non-invasive assessment of the shape of the curvature of the spine and parameters that determine postural disorders. The ZEBRIS system consists of a measuring unit, a system of micro-sensors and an ultrasonic pointer, with which topographic points are scanned from the skeleton and then processed in a computer program in the form of a report containing numerical data specifying lengths, angles and degrees for each parameter, as well as graphs and figures of the spinal line.
Assessment of concentration and attention with HEG Biofeedback (hemoencephalography)
Time frame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program.
Hemoencephalography (HEG) is a method of monitoring changes in frontal cerebral blood circulation and oxygenation. HEG biofeedback is a method based on the use of near-infrared technology to measure cerebral hemodynamics. A sensor armband is placed on the head in the area where reduced blood oxygenation is noted, and then emits into the brain, two beams of light at different frequencies. This allows us to check the oxygen saturation in a particular area of the brain in real time. The signal is returned to the computer screen, and the trainer tries to increase it. HEG biofeedback training involves stimulating neurons in the frontal lobes of the brain.
11 secondary outcomes
Assessment of functional by Barthel Scale
Time frame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program.
Quality of life assessment using the PedsQLTM Pediatric Quality of Life Questionnaire
Time frame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
Assessment of cognitive function using the AVLT test
Time frame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
Assessment of cognitive function using the Bourdon-Wiersma test
Time frame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
Manual skills, assessed with Box and Blocks test
Time frame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
Romberg test
Time frame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
TUG test
Time frame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
Southern California Sensory Integration Test - Bilateral Motor Coordination
Time frame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
Southern California Sensory Integration Test - Crossing the Body's Midline
Time frame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
Southern California Sensory Integration Test - Graphesthesia
Time frame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
Southern California Sensory Integration Test - Differentiating Right from Left
Time frame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
Related trials for Intellectual Disability, Mild
Enrolling by invitation
Comparing the Impact of Peer Support vs. Staff-Delivered Transportation Interventions for Young Adults With Intellectual and Developmental Disabilities.
Intellectual Disability, Mild to Moderate, Developmental Disability
Recruiting
ICF-Based Interdisciplinary Case Management for Individuals With Disabilities
Intellectual Disability, Mild to Moderate, Developmental Disability
Active, not recruiting
Effects of a 12-Week Pickleball Training Program on Cognitive and Motor Skills in Adolescents With Mild Intellectual Disability
Intellectual Disability, Mild
Active, not recruiting
Real-Time Pose Recognition Technology for Improving Tennis Learning in Individuals With Intellectual Disabilities
Intellectual Disability, Mild to Moderate, Adolescence
Not yet recruiting
Effect of Virtual Reality Distraction on Perceived Pain During Dental Hygiene in Children With Mild Intellectual Disability
Mild Intellectual Disability
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback method and Conventional therapy program in people with Intellectual Disability, Mild, run by Aleksandra Kiper at 1 site in Poland.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aleksandra Ewa Kiper, MSc (+48607974712, akiper94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of static and dynamic balance using the AMTI platform (time frame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program.). The study lists 3 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 7 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.