Clinical trial NCT06120686: Biofeedback Training's Impact on Cognitive and Motor Skills in Kids With Intellectual Disabilities
Official title: Effect of Biofeedback Training on Cognitive and Motor Functions in Children With Intellectual Disabilities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intellectual Disability, Mild
Keywords: intellectual disability
cognitive function
motor function
training
rehabilitation
biofeedback
Lead sponsor: University of Rzeszow
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: random selection to two groups (study group and control group)
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Assessment of static and dynamic balance using the AMTI platform
timeFrame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program.
measure: Posture assessment using the computer-based ZEBRIS system
timeFrame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program.
measure: Assessment of concentration and attention with HEG Biofeedback (hemoencephalography)
timeFrame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program.
Secondary outcomes:
measure: Assessment of functional by Barthel Scale
timeFrame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program.
measure: Quality of life assessment using the PedsQLTM Pediatric Quality of Life Questionnaire
timeFrame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
measure: Assessment of cognitive function using the AVLT test
timeFrame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
measure: Assessment of cognitive function using the Bourdon-Wiersma test
timeFrame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
measure: Manual skills, assessed with Box and Blocks test
timeFrame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
measure: Romberg test
timeFrame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
measure: TUG test
timeFrame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
measure: Southern California Sensory Integration Test - Bilateral Motor Coordination
timeFrame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
measure: Southern California Sensory Integration Test - Crossing the Body's Midline
timeFrame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
measure: Southern California Sensory Integration Test - Graphesthesia
timeFrame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
measure: Southern California Sensory Integration Test - Differentiating Right from Left
timeFrame: First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program
Other outcomes:
Locations:
city: Rzeszów
country: Poland
facility: University of Rzeszów
Study officials:
References: