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Completed

NCT Number: NCT07096817

Effects of a Highly Intensive Balance Therapy Camp in Children With Developmental Coordination Disorder

The main objective of this clinical trial is to investigate the short (immediately after intervention) and medium term (three month) effects of a highly intensive, comprehensive postural control 6-day therapy camp in school-aged children (6 to 12 years) with developmental coordination disorder at different levels of the The International Classification of Functioning, Disability and Health (ICF) framework.

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Key information

Conditions

Developmental Coordination Disorder Mental Disorders Motor Skills Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasselt University

Diepenbeek, Limburg, 3590, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed with DCD by a pediatrician, using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria: (i) motor skill acquisition and performance is at an age-inappropriate level (Criterion A), objectified with the total MABC-2 score at or below the 16th percentile or subscale score at or below the 5th percentile; (ii) the motor skills deficit significantly and persistently interferes with the activities of everyday living (Criterion B), objectified with the DCD Questionnaire 2007 (DCD-Q) ; (iii) Onset of symptoms in early childhood (Criterion C) evaluated by anamnesis with parents; (iv) The motor skills deficits are not better accounted for by any other medical (neurological, intellectual, visual, etc.), neurodevelopmental, psychological, social condition, or cultural background (criterion D), evaluated by a neuromotor examination performed by an acknowledged pediatrician.
  • children who have no formal diagnosis are evaluated by the research team using the diagnostic criteria as outlined in the inclusion criteria. In this case, Criterion D is evaluated based on anamnesis and clinical examination. If criterion A, B, C are met and other intellectual, visual or neurological conditions have not been reported, they are included as having "probable" DCD.
  • Due to the interventional focus on postural control, children are only included if they score below the 50th percentile for the balance subscale of the MABC-2 and below 80% on the Kids-BESTest total score.
  • Due to the high comorbidity rate in children with DCD, such as attention deficit hyperactivity disorder (ADHD), autism spectrum disorder (ASD) and dyslexia, the comorbidities are listed through thorough anamnesis and the Strengths and difficulties questionnaire (SDQ) is used.

Exclusion criteria

  • not able to follow instructions or cooperate sufficiently due to behavioral problems

Treatment and study plan

Highly intensive individualized balance therapy

Behavioral

In the form of a camp with total therapy hours of 40 hours with a central theme of "Circus", children will receive individualized (1 therapist per child) intensive therapy. The intervention is functional, and divided in six activity categories: jumping, sitting balance, walking and running, circus, individual goals and group activities with focus on social interaction. Each category should: 1. partially or fully cover the multisystemic balance framework of Horak, with the overall program covering the entire framework, 2. be fun and focusing on collaboration rather than competition.

Primary outcomes

  1. Changes in Balance Evaluation Systems Test (Kids-BESTest) scores

    Time frame: 6 months pre-assessment, 3 months pre-assessment, pre-interventional assessment (up to two weeks before the start of the intervention), post-interventional assessment (up to two weeks after the end of the intervention), 3 months follow-up assessment

    The Kids-BESTest is a standardized performance tool to assess postural control in children aged between 5 and 18 years old. The test has excellent reliability and consists of 36 items divided over 6 domains. Items are scored from 0 (worst performance) to 3 (normal performance) on 4-point Likert scale. Based on the summation of the task scores, the domain and total scores can be calculated and expressed as a percentage (minimum 0 - maximum 100). A higher score means a better balance performance.

Secondary outcomes

  1. Change in scores on the Canadian Occupational Performance Measure (COPM)

    Time frame: pre-interventional assessment (up to two weeks before the start of the intervention), post-interventional assessment (up to two weeks after the end of the intervention), 3 month follow-up assessment

    The COPM is a client-centered outcome measure to determine and evaluate individual treatment goals. Measurement properties are satisfactory to excellent. In a semi-structured interview between therapist and child (over 8 years) or parents (under 8 years) balance-related problems in daily living are determined. After scoring for importance on a 10-point rating scale (minimum 1 - maximum 10), up to 3 self-selected treatment goals are identified. Each goal is self-rated based on the level of performance and satisfaction. In this study the Dutch version is used. Higher scores indicate more satisfaction and better performance.

  2. Change in scores of the Test of Gross Motor Development, 3rd edition (TGMD-3)

    Time frame: 6 months pre-assessment, 3 months pre-assessment, pre-interventional assessment (up to two weeks before the start of the intervention), post-interventional assessment (up to two weeks after the end of the intervention), 3 months follow-up assessment

    The TGMD-3 is a functional process-oriented test to assess fundamental motor skills in children between 3 and 10 years old, with high test-retest reliability and validity. The test consists of 13 fundamental motor skills, subdivided across two subscales: locomotor and object control skills. Each skill is assessed with three to five performance criteria reflecting the developmental stage of the movement pattern. If a criterion is reached a score 1 is given, if not a score 0 is given. Each skill is assessed 2 times. All criterion scores of the two repetitions of each skill is summed up to obtain the domain scores. These raw domain scores are corrected for age and sex to a scaled score per domain (minimum 1 - maximum 20). Afterwards the scaled score for the total score (gross motor index) is calculated. The scaled scores are used for analyses. A higher score means a better motor performance.

  3. Changes muscle activation patterns during balance tasks (measured with surface electromyography): onset latencies

    Time frame: 6 months pre-assessment, pre-interventional assessment (up to two weeks before the start of the intervention), post-interventional assessment (up to two weeks after the end of the intervention), 3 months follow-up assessment

    Surface EMG is a reliable tool that can be used to measure muscle activity in lumbar and lower limb muscles. Muscle activity is registered using sEMG TrignoTM, Delsys Inc., USA. Registered muscles are: m. gastrocnemius medial head, m. tibialis anterior, m. rectus femoris, m. biceps femoris, m. gluteus medius and mm. erector spinae. Outcome measure regarding sEMG is onset latencies (time in ms). Sensor placement and locations are performed in accordance with the SENIAM guidelines. Muscle activity is registered simultaneously with fNIRS during performance of Kids-BESTest tasks.

  4. Changes muscle activation patterns during balance tasks (measured with surface electromyography): time to peak

    Time frame: 6 months pre-assessment, pre-interventional assessment (up to two weeks before the start of the intervention), post-interventional assessment (up to two weeks after the end of the intervention), 3 months follow-up assessment

    Surface EMG is a reliable tool that can be used to measure muscle activity in lumbar and lower limb muscles. Muscle activity is registered using sEMG TrignoTM, Delsys Inc., USA. Registered muscles are: m. gastrocnemius medial head, m. tibialis anterior, m. rectus femoris, m. biceps femoris, m. gluteus medius and mm. erector spinae. Outcome measure regarding sEMG is time to peak activity (time in ms). Sensor placement and locations are performed in accordance with the SENIAM guidelines. Muscle activity is registered simultaneously with fNIRS during performance of Kids-BESTest tasks.

  5. Changes muscle activation patterns during balance tasks (measured with surface electromyography): co-contraction

    Time frame: 6 months pre-assessment, pre-interventional assessment (up to two weeks before the start of the intervention), post-interventional assessment (up to two weeks after the end of the intervention), 3 months follow-up assessment

    Surface EMG is a reliable tool that can be used to measure muscle activity in lumbar and lower limb muscles. Muscle activity is registered using sEMG TrignoTM, Delsys Inc., USA. Registered muscles are: m. gastrocnemius medial head, m. tibialis anterior, m. rectus femoris, m. biceps femoris, m. gluteus medius and mm. erector spinae. Outcome measure regarding sEMG is co-contraction (percentage). Sensor placement and locations are performed in accordance with the SENIAM guidelines. Muscle activity is registered simultaneously with fNIRS during performance of Kids-BESTest tasks.

  6. Changes in oxy-hemoglobin levels in different cortical brain regions during balance tasks (measured with functional Near-Infrared Spectroscopy)

    Time frame: 6 months pre-assessment, pre-interventional assessment (up to two weeks before the start of the intervention), post-interventional assessment (up to two weeks after the end of the intervention)

    To register cortical brain activity, fNIRS is applied simultaneously with preselected Kids-BESTest tasks. This optical neuro-imaging technique uses infrared light to monitor changes in the concentration (μmol/l) of oxygenated (HbO2) between the task and baseline condition. It is a reliable tool for within-subject measurements and can be reliably applied in children. Due to its portability, it can be used during postural control tasks and gait measurements. The NIRSport 2 (NIRx Medical Technologies, GE) with continuous wave (760nm; 850nm) imaging is used. The region of interests (ROI) targeted with fNIRS were determined based on evidence of brain areas responsible for adequate postural control tasks in healthy individuals and affected brain areas in children with DCD in a variety of tasks. The ROI include the inferior (IPL) and superior parietal lobe (SPL), premotor cortex (PMC) and the supplementary motor area (SMA).

  7. Changes in deoxy-hemoglobin levels in different cortical brain regions during balance tasks (measured with functional Near-Infrared Spectroscopy)

    Time frame: 6 months pre-assessment, pre-interventional assessment (up to two weeks before the start of the intervention), post-interventional assessment (up to two weeks after the end of the intervention)

    To register cortical brain activity, fNIRS is applied simultaneously with preselected Kids-BESTest tasks. This optical neuro-imaging technique uses infrared light to monitor changes in the concentration (μmol/l) of deoxygenated hemoglobin (HHb) between the task and baseline condition. It is a reliable tool for within-subject measurements and can be reliably applied in children. Due to its portability, it can be used during postural control tasks and gait measurements. The NIRSport 2 (NIRx Medical Technologies, GE) with continuous wave (760nm; 850nm) imaging is used. The region of interests (ROI) targeted with fNIRS were determined based on evidence of brain areas responsible for adequate postural control tasks in healthy individuals and affected brain areas in children with DCD in a variety of tasks. The ROI include the inferior (IPL) and superior parietal lobe (SPL), premotor cortex (PMC) and the supplementary motor area (SMA).

  8. Self-perceived competence measured with "Competentiebelevingsschaal voor kinderen (CBSK) (=Dutch)

    Time frame: 6 months pre-assessment, 3 months pre-assessment, pre-interventional assessment (up to two weeks before the start of the intervention), post-interventional assessment (up to two weeks after the end of the intervention), 3 months follow-up assessment

    In children 8-12 years self-perceived competence is assessed with CBSK. The CBSK is reliable and consists of 36 items across six domains: scholastic competence, social acceptation, athletic competence, physical appearance, behavioral conduct and global self-worth. Each item is scored on a 4-point ordinal scale. Raw subscale scores are converted to percentile scores (minimum 0 - maximum 100).

  9. Parents' perception of their child using a qualitative questionnaire and interview parents

    Time frame: pre-interventional assessment (up to two weeks before the start of the intervention), post-interventional assessment (up to two weeks after the end of the intervention), 3 months follow-up assessment

    Parents' perception of their child is questioned with 14 open questions on the child, parents, family and social contacts. Before intervention, parents list their baseline findings, changes are questioned after intervention. Based on these answers, a focus group with the parents is organized at follow-up.

  10. Questionnaire for therapists

    Time frame: pre-interventional assessment (up to two weeks before the start of the intervention), 3 months follow-up assessment

    Details (goals, frequency, duration) on the participants' therapy and potential changes in content since the first baseline measurement were questioned with the therapists before intervention. If during the therapy time before and after the camp, postural control goals were set, training methods were inventoried. On follow-up, changes in therapy goals and potential changes in performance are questioned.

  11. Pictorial scale of perceived competence and social acceptance (PSPCSA)

    Time frame: 6 months pre-assessment, 3 months pre-assessment, pre-interventional assessment (up to two weeks before the start of the intervention), post-interventional assessment (up to two weeks after the end of the intervention), 3 months follow-up assessment

    In children aged 6-7 years, the PSPCSA is used. The PSPCSA is reliable and consists 24 items across 4 domains (cognitive competence, physical competence, peer acceptance and maternal acceptance). Items are scored on a 4-point ordinal scale. Raw subscale scores can be calculated, with higher scores indicating higher competence (minimum 24 - maximum 48).

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Registry information

Official study title

Fundamental Insights Into the Interplay Between Postural Control and Motor Development in Children With DCD: a Synergistic Approach of Functional Evaluations, Neuromechanics and Brain Activity

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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