Biofeedback Training's Impact on Cognitive and Motor Skills in Kids With Intellectual Disabilities

NCT06120686 | Unknown

• 1 other identifier: 2023/07/48
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Intellectual Disability, Mild

Keywords

intellectual disability; cognitive function; motor function; training; rehabilitation; biofeedback

Outcome Measures

Primary Outcomes (3)

• Assessment of static and dynamic balance using the AMTI platform

  AMTI platform use is to assess balance ability.

  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.

  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.

  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

  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

  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

  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

  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

  First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program

Study Arms (2)

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

Other: Biofeedback method; Other: Conventional therapy program

conventional therapy program (CT)

OTHER

control group - implementing only the conventional therapy program

Other: Conventional therapy program

Interventions

Biofeedback method OTHER

Study group - implementing a conventional therapy program supplemented additionally with visual and auditory biofeedback training on a dynamic balance platform

Also known as: Conventional therapy program

biofeedback-based therapy (BBT)

Conventional therapy program OTHER

Control group - rehabilitation management aimed at improving cognitive and motor functions in children with mild intellectual disabilities.

biofeedback-based therapy (BBT); conventional therapy program (CT)

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aleksandra Kiper: lead

Study Sites (1)

University of Rzeszów

Rzeszów, 35-959, Poland

RECRUITING

MeSH Terms

Conditions

Intellectual Disability; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Aleksandra Ewa Kiper, MSc

CONTACT

+48607974712; akiper94@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master of Physiotherapy

Model Details: random selection to two groups (study group and control group)

Study Record Dates

• First Submitted: October 14, 2023
• First Posted: November 7, 2023
• Study Start: November 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: January 1, 2025
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

PL (1)