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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05208255
Other study ID # Buker N
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 15, 2022
Est. completion date June 1, 2023

Study information

Verified date January 2022
Source Izmir Katip Celebi University
Contact Nurullah Buker
Phone +905445273032
Email nurullahbuker@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common neurodevelopmental disorders with heterogeneous clinical features such as inattention, hyperactivity, and impulsivity. It has been shown that one-third of children with ADHD have problems with tasks that require fine and gross motor skills. In addition, it was stated that the motor skill problems experienced during dynamic balance tasks were more pronounced than typically developing children. The motor problems seen in children with ADHD may be caused by dysfunction in some related brain regions that delayed or impaired cerebellar development may contribute to the pathophysiology of ADHD. Motor imagery skills have been investigated as the underlying cause of motor impairment in children with ADHD and Developmental Coordination Disorder (DCD). Although it has shown that motor imagery is markedly impaired in children with DID; It has been stated that this situation is not clear in children with ADHD. Motor imagery is the mental thinking of a movement without actual movement being revealed. It has been reported that combined physical and mental programs applied at different rates, as well as motor imagery training without physical exercise, are effective in improving postural control. In a study conducted with children with DCD, it was shown that motor imagery training improves children's movement skills. In the treatment of ADHD, there are multidimensional treatment approaches that include medical and psychosocial interventions. Pharmacological treatments, including stimulant and non-stimulant drugs, are highly effective in reducing ADHD symptoms and the disruptive behaviours associated with them. Also, physical exercises are known to reduce ADHD symptoms. Exercise methods enable patients receiving drug therapy to respond better to drugs, it has been shown to improve cognitive functions in ADHD cases. In conclusion, the underlying aetiology of motor imagery skills and motor coordination and balance problems in ADHD is not clear. The use of telerehabilitation methods has become widespread due to the difficulties in conducting face-to-face treatment and follow-up processes during the pandemic process. In addition, there is no exercise program based on telerehabilitation and motor imagery in children with ADHD. This study aims to examine the effects of telerehabilitation-based exercise and motor imagery practices on ADHD symptoms and balance skills in children with ADHD.


Description:

Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common neurodevelopmental disorders in children. 7.2% in the world; ADHD with a prevalence of approximately 13% in Turkey; It is a disorder that affects impulsivity, inattention and hyperactivity symptoms, and affects daily life activities and causes inadequacies. Children with ADHD have lower motor skills and performance than healthy children; reported to have higher motor coordination disorders. It has been shown that one-third of children with ADHD have problems with tasks that require fine and gross motor skills. In addition, it was stated that the motor skill problems experienced during dynamic situations were more pronounced than healthy children. It has been reported that motor disorders seen in children with ADHD may result from dysfunction in some related brain regions, and that especially delayed or impaired cerebellar development may contribute to the pathophysiology of ADHD. ADHD can cause significant academic, social and psychiatric problems. If left untreated, these problems continue for life. Motor imagery was investigated as the underlying cause of motor impairment in children with ADHD and Developmental Coordination Disorder (DDD). It was stated that motor imagery was significantly impaired in children with ADHD. But this situation was not clear in children with ADHD. Motor imagery is defined as the mental thinking of a movement without actual movement being revealed. It has been reported that combined physical and motor imagery programs applied at different rates, as well as motor imagery training without physical exercise, are effective in improving postural control. In a study conducted with children with DCD, it was shown that motor imagery training improves children's movement skills. In the treatment of ADHD, there are multidimensional treatment approaches that include medical and psychosocial interventions. Psychostimulants are the drugs most commonly used in the treatment of ADHD. Pharmacological treatments, including stimulant and non-stimulant drugs, are highly effective in reducing ADHD's attention deficit and hyperactivity/impulsivity features and associated destructive behaviors. In addition, from psycho-educational interventions; Multiple approach models that combine psychosocial intervention such as family education, school-oriented regulation, cognitive behavioral therapy, and social education have also been found to be effective methods. When looking at the effective exercise methods on ADHD symptoms, there are mostly studies on aerobic exercises and other physical exercises. Also, other physical exercises are known to reduce ADHD symptoms. It has been shown that exercise methods enable patients receiving drug therapy to respond better to drugs and improve cognitive functions in ADHD cases. Due to the Coronavirus disease (Covid-19), which started in the last months of 2019 and whose negative effects are still continuing, some difficulties are experienced in the health systems. This situation has led to a greater tendency towards telerehabilitation applications during the treatment and follow-up process. Telerehabilitation is a method that aims to provide rehabilitation to patients and clinicians by using information and communication technologies by reducing obstacles such as distance, time and cost. Although telerehabilitation programs have been used in different disease groups in recent years, these programs use is not common in children with ADHD. In conclusion, motor imagery disorder is unclear in children with ADHD. In addition, there are different opinions about the underlying aetiology of motor coordination and balance problems that cause children with ADHD to have difficulties in daily life and sports activities. The use of telerehabilitation methods has become widespread due to the difficulties in conducting face-to-face treatment and follow-up processes due to the pandemic. In addition, there is no exercise program based on telerehabilitation and motor imagery in children with ADHD.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 36
Est. completion date June 1, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers No
Gender All
Age group 7 Years to 12 Years
Eligibility Inclusion Criteria: - Diagnosis of ADHD - Between the ages of 7-12 - Volunteer - Not using psychostimulant drugs for at least two months Exclusion Criteria: - Having a systemic disease that affects physical assessments - Having severe visual impairment (color blindness, strabismus, etc.) - Having a neurological disease - Having a musculoskeletal disease - Having any neuropsychiatric disorder other than Oppositional Defiant Disorder, anxiety disorders, and mood disorders - Having Developmental Coordination Disorder - Have previously participated in a motor imaging or motor imaging-like study/practice - Having an IQ score of 80 and below - Being a licensed athlete

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise
NEP is a multimodal exercise program including different motor coordination exercises and cognitive tasks. Exercises are progressed from simple to complex tasks. Varied equipment (such as different sized balls, rackets, tulles, exercises balls, eye bands, ropes etc.) is used during different exercises containing cross-limb movements, throwing, jumping, walking, and cognitive tasks. Although the stages of the NEP and exercise selection are the same for each participant, the use of materials or cognitive tasks selection may differ according to the age and skill of the participant. The cognitive tasks were performed by using different visual (colored cards, numbered cards etc.) or auditory cues. Motor Imagery Program: Motor imagery (MI) is a dynamic mental state during which the representation of a given motor movement is rehearsed in working memory without overt motor output. MI training will be performed in the form of imagined NEP exercises in the last 15 minutes of the session.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Izmir Katip Celebi University Dokuz Eylul University

Outcome

Type Measure Description Time frame Safety issue
Primary Conners Parent Rating Scale-Revised Short It determines the severity of ADHD symptoms. The scale consists of three sub-scales (Oppositional Defiant, Cognitive Problems-Inattention, Hyperactivity) and an auxiliary scale (ADHD Index). The questions are answered by the parents on a four-point Likert scale as "Never", "rarely", "often", and "always" which are scored as "0", "1", "2", and "3", respectively. pre-intervention
Primary Conners Parent Rating Scale-Revised Short It determines the severity of ADHD symptoms. The scale consists of three sub-scales (Oppositional Defiant, Cognitive Problems-Inattention, Hyperactivity) and an auxiliary scale (ADHD Index). The questions are answered by the parents on a four-point Likert scale as "Never", "rarely", "often", and "always" which are scored as "0", "1", "2", and "3", respectively. within the first week post-intervention
Primary Stroop Test The Stroop Test is a task assessing executive function involving processing speed, concentration, and selective attention. Stroop Test was applied in five sections. These sections and related cards are as follows in their application order: (1) The card with the color names printed in black (1st card); (2) the card with the color names printed in different colors (2nd card); (3) the card with the colored printed circles (3rd card); (4) in the card with neutral words without the color name (4th Card); (5) the section where the colors of the words in the 2nd Card are spelt, with the names of colors printed in different colors. pre-intervention
Primary Stroop Test The Stroop Test is a task assessing executive function involving processing speed, concentration, and selective attention. Stroop Test was applied in five sections. These sections and related cards are as follows in their application order: (1) The card with the color names printed in black (1st card); (2) the card with the color names printed in different colors (2nd card); (3) the card with the colored printed circles (3rd card); (4) in the card with neutral words without the color name (4th Card); (5) the section where the colors of the words in the 2nd Card are spelt, with the names of colors printed in different colors. within the first week post-intervention
Primary d2 Test of Attention The d2 Test measures processing speed, rule compliance, and quality of performance, allowing for a neuropsychological estimation of individual attention and concentration performance. pre-intervention
Primary d2 Test of Attention The d2 Test measures processing speed, rule compliance, and quality of performance, allowing for a neuropsychological estimation of individual attention and concentration performance. within the first week post-intervention
Primary Y Balance Test Y-Balance Test is used to evaluate the dynamic balance. YBT is performed in three directions (anterior, posteromedial, and posterolateral). pre-intervention
Primary Y Balance Test Y-Balance Test is used to evaluate the dynamic balance. YBT is performed in three directions (anterior, posteromedial, and posterolateral). within the first week post-intervention
Primary Timed Up and Go Test The Timed Up and Go Test, which is found an excellent level of validity and reproducibility by Nicolini and Donadio, is performed as the standard test protocol applied in children to evaluate dynamic balance and functionality. pre-intervention
Primary Timed Up and Go Test The Timed Up and Go Test, which is found an excellent level of validity and reproducibility by Nicolini and Donadio, is performed as the standard test protocol applied in children to evaluate dynamic balance and functionality. within the first week post-intervention
Secondary Movement Imagery Questionnaire-Revised Second Edition The Motion Imagery Questionnaire-Revised Second Edition will be used to measure children's visual and kinesthetic visualization skills. It consists of 14 items, seven of which are visual and 7 of which are kinesthetic. During the test, children scores by asking them to perform the actions in the instruction once in reality, then to visualize the movement they do and to indicate the clarity of this imagery on a Likert-type scale from 1 (Very difficult to feel/see) to 7 (Very easy to feel/see). pre-intervention
Secondary Movement Imagery Questionnaire-Revised Second Edition The Motion Imagery Questionnaire-Revised Second Edition will be used to measure children's visual and kinesthetic visualization skills. It consists of 14 items, seven of which are visual and 7 of which are kinesthetic. During the test, children scores by asking them to perform the actions in the instruction once in reality, then to visualize the movement they do and to indicate the clarity of this imagery on a Likert-type scale from 1 (Very difficult to feel/see) to 7 (Very easy to feel/see). within the first week post-intervention
Secondary Kinesthetic and Visual Imagery Ouestionnaire The form consists of a total of 10 movements that measure five visual and five kinesthetic visualization skills developed to determine the extent to which individuals visualize and feel the imagined movements. The evaluator performs the relevant move on himself and then asks the participant to do the same movement only once. Then, the participant imagines the movement, and the visual clarity of the imaged movement or the senses are scored with the help of a 5-point ordinal scale. pre-intervention
Secondary Kinesthetic and Visual Imagery Ouestionnaire The form consists of a total of 10 movements that measure five visual and five kinesthetic visualization skills developed to determine the extent to which individuals visualize and feel the imagined movements. The evaluator performs the relevant move on himself and then asks the participant to do the same movement only once. Then, the participant imagines the movement, and the visual clarity of the imaged movement or the senses are scored with the help of a 5-point ordinal scale. within the first week post-intervention
Secondary Timed Up and Go-Mental Chronometer This test will be performed while sitting position in a chair at the beginning of the Timed Get Up and Go Test track. Individuals are asked to complete the TUG by imagining with their eyes closed, and the time to complete the test is recorded with a chronometer. The temporal coherence between the real and the imagined movement is calculated in terms of delta time with the formula '(real motion-imagined motion) / [(real motion+imagined motion) / 2] x 100'. pre-intervention
Secondary Timed Up and Go-Mental Chronometer This test will be performed while sitting position in a chair at the beginning of the Timed Get Up and Go Test track. Individuals are asked to complete the TUG by imagining with their eyes closed, and the time to complete the test is recorded with a chronometer. The temporal coherence between the real and the imagined movement is calculated in terms of delta time with the formula '(real motion-imagined motion) / [(real motion+imagined motion) / 2] x 100'. within the first week post-intervention
Secondary Ruler Drop Test It is a simple and inexpensive test used to evaluate the hand reaction time. For the test, a 50 cm ruler will be used. During the test, the person is asked to sit comfortably with his dominant arm on the table. The practitioner randomly leaves the ruler at hand level for 2-5 seconds, and the person is asked to grasp the ruler as quickly as possible. The distance the person has caught the ruler is recorded. The average of three measurements made after two trial tests will be taken as the test value. pre-intervention
Secondary Ruler Drop Test It is a simple and inexpensive test used to evaluate the hand reaction time. For the test, a 50 cm ruler will be used. During the test, the person is asked to sit comfortably with his dominant arm on the table. The practitioner randomly leaves the ruler at hand level for 2-5 seconds, and the person is asked to grasp the ruler as quickly as possible. The distance the person has caught the ruler is recorded. The average of three measurements made after two trial tests will be taken as the test value. within the first week post-intervention
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