Effect of Biofeedback Training on Cognitive and Motor Functions in Children With Intellectual Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Assessment of static and dynamic balance using the AMTI platform
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Assessment of static and dynamic balance using the AMTI platform
时间窗: 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.
Assessment of concentration and attention with HEG Biofeedback (hemoencephalography)
时间窗: 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.
Posture assessment using the computer-based ZEBRIS system
时间窗: 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.
次要结局
- TUG test(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)
- Southern California Sensory Integration Test - Graphesthesia(First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program)
- 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.)
- Southern California Sensory Integration Test - Bilateral Motor Coordination(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(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)
- Romberg test(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(First examination - before the start of the rehabilitation program; second examination - at the end of the three-week program)
研究者
Aleksandra Kiper
Master of Physiotherapy
University of Rzeszow