NCT07096817

Brief 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 the The International Classification of Functioning, Disability and Health (ICF) framework.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

2.1 years

First QC Date

July 11, 2025

Last Update Submit

July 30, 2025

Conditions

Keywords

"Postural Balance"[Mesh]"Pediatrics"[Mesh]Developmental Coordination Disorder"Motor Skills Disorders"[Mesh]Postural ControlRehabilitationFunctional TherapyHighly intensive therapyMotor learningIndividual therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    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)

    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

    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

    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

    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

  • +6 more secondary outcomes

Study Arms (1)

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.

Behavioral: Highly intensive individualized balance therapy

Interventions

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.

Individualized balance therapy (with follow-up after and baseline follow-up)

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Diepenbeek, Limburg, 3590, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 38382234BACKGROUND

Related Links

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The Kids-BESTest and TGMD-3 performances are videotaped and scored on video by an experienced assessor. Assessors are blinded for the pre-post condition and timing of the assessment.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

July 11, 2025

First Posted

July 31, 2025

Study Start

November 2, 2022

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results, after deidentification (text, tables, figures, and appendices)

Shared Documents
STUDY PROTOCOL
Time Frame
After publication of results
Access Criteria
Researchers who provide a methodologically sound proposal

Locations