Developmental Coordination DisorderNCT07096817
Effects of a Highly Intensive Balance Therapy Camp in Children With Developmental Coordination Disorder
A study testing Highly intensive individualized balance therapy in people with Developmental Coordination Disorder, run by Hasselt University at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Developmental Coordination Disorder
- What is being tested?
- Highly intensive individualized balance therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Nov 2022to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- not able to follow instructions or cooperate sufficiently due to behavioral problems
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Developmental Coordination Disorder
- Being tested
- Highly intensive individualized balance therapy
- Keywords
- "Postural Balance"[Mesh], "Pediatrics"[Mesh], Developmental Coordination Disorder, "Motor Skills Disorders"[Mesh], Postural Control, Rehabilitation, Functional Therapy, Highly intensive therapy, Motor learning, Individual therapy
- Medical subject headings
- Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Highly intensive individualized balance therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Individualized balance therapy (with follow-up after and baseline follow-up) | Experimental | The therapy of the children will be given in intensive camps. A total of four camps are organized between April 2023 and August 2024. Each camp consists of six days of therapy, with a total therapy time of 40 hours. The central camp theme is "Circus", due to the attractiveness for children and the link with postural control. 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 (Table 2). Each category should: 1. partially or fully cover the multisystemic framework of Horak, with the overall program covering the entire framework , 2. be fun and focusing on collaboration rather than competition.
During three months prior to the intervention (camps), the children are followed up for six months and assessed at three time points. They will keep on following their usual physiotherapy sessions. Receives: Behavioral: Highly intensive individualized balance therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Balance Evaluation Systems Test (Kids-BESTest) scores
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.
Measured: 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
Secondary outcomes (11)
Change in scores on the Canadian Occupational Performance Measure (COPM)
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.
Measured: 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
Change in scores of the Test of Gross Motor Development, 3rd edition (TGMD-3)
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.
Measured: 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
Changes muscle activation patterns during balance tasks (measured with surface electromyography): onset latencies
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.
Measured: 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
Changes muscle activation patterns during balance tasks (measured with surface electromyography): time to peak
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.
Measured: 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
Changes muscle activation patterns during balance tasks (measured with surface electromyography): co-contraction
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.
Measured: 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
Changes in oxy-hemoglobin levels in different cortical brain regions during balance tasks (measured with functional Near-Infrared Spectroscopy)
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).
Measured: 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)
Changes in deoxy-hemoglobin levels in different cortical brain regions during balance tasks (measured with functional Near-Infrared Spectroscopy)
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).
Measured: 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)
Self-perceived competence measured with "Competentiebelevingsschaal voor kinderen (CBSK) (=Dutch)
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).
Measured: 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
Parents' perception of their child using a qualitative questionnaire and interview parents
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.
Measured: 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
Questionnaire for therapists
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.
Measured: pre-interventional assessment (up to two weeks before the start of the intervention), 3 months follow-up assessment
Pictorial scale of perceived competence and social acceptance (PSPCSA)
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).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start2 Nov 2022
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Developmental Coordination DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pre-post interventional test design with a triple, nontraining baseline and follow-up. After inclusion, participants are followed for six months prior to the intervention using a triple baseline consisting of six months pre-assessment (T1), a three-months pre-assessment (T2) and a pre-interventional assessment, up to two weeks before the intervention (T3). After the camp, patients perform a post-interventional assessment, up to two weeks after the end of the intervention (T4) and a three-month follow-up assessment (T5)
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrijn Klingels, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096817
- Sponsor's protocol ID
- 21KP09BOF
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results, after deidentification (text, tables, figures, and appendices)
Publications
Velghe S, Rameckers E, Meyns P, Johnson C, Hallemans A, Verbecque E, Klingels K. Effects of a highly intensive balance therapy camp in children with developmental coordination disorder - An intervention protocol. Res Dev Disabil. 2024 Apr;147:104694. doi: 10.1016/j.ridd.2024.104694. Epub 2024 Feb 20.
PubMed 38382234
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07096817
- Acronym / sponsor ID
- 21KP09BOF
- Conditions
- Developmental Coordination Disorder
- Keywords
- "Postural Balance"[Mesh], "Pediatrics"[Mesh], Developmental Coordination Disorder, "Motor Skills Disorders"[Mesh], Postural Control, Rehabilitation, Functional Therapy, Highly intensive therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pre-post interventional test design with a triple, nontraining baseline and follow-up. After inclusion, participants are followed for six months prior to the intervention using a triple baseline consisting of six months pre-assessment (T1), a three-months pre-assessment (T2) and a pre-interventional assessment, up to two weeks before the intervention (T3). After the camp, patients perform a post-interventional assessment, up to two weeks after the end of the intervention (T4) and a three-month follow-up assessment (T5)
| Arm | Type | Receives |
|---|---|---|
| Individualized balance therapy (with follow-up after and baseline follow-up) | Experimental | Behavioral: Highly intensive individualized balance therapyThe therapy of the children will be given in intensive camps. A total of four camps are organized between April 2023 and August 2024. Each camp consists of six days of therapy, with a total therapy time of 40 hours. The central camp theme is "Circus", due to the attractiveness for children and the link with postural control. 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 (Table 2). Each category should: 1. partially or fully cover the multisystemic framework of Horak, with the overall program covering the entire framework , 2. be fun and focusing on collaboration rather than competition. During three months prior to the intervention (camps), the children are followed up for six months and assessed at three time points. They will keep on following their usual physiotherapy sessions. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- not able to follow instructions or cooperate sufficiently due to behavioral problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Highly intensive individualized balance therapyIn 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. | Behavioural | Individualized balance therapy (with follow-up after and baseline follow-up) |
Primary outcome
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.
11 secondary outcomes
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
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
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
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
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
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)
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)
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
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
Questionnaire for therapists
Time frame: pre-interventional assessment (up to two weeks before the start of the intervention), 3 months follow-up assessment
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Background: PubMed 38382234Velghe S, Rameckers E, Meyns P, Johnson C, Hallemans A, Verbecque E, Klingels K. Effects of a highly intensive balance therapy camp in children with developmental coordination disorder - An intervention protocol. Res Dev Disabil. 2024 Apr;147:104694. doi: 10.1016/j.ridd.2024.104694. Epub 2024 Feb 20.
- website with study information and possibility for enrolment, target group: parents and therapistsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results, after deidentification (text, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Highly intensive individualized balance therapy in people with Developmental Coordination Disorder, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07096817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.