Influence of Sensory Stimulation on Sensory Parameters and Motor Function in Children With Developmental Coordination Disorder

NCT06959329 | Not Yet Recruiting

• 1 other identifier: LAR/2025/mar/01
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 2

Brief Summary

The goal of this clinical trial is to evaluate whether intensive sensory stimulation therapy can improve upper limb motor skills and sensory function in children aged 12-16 years with severe symptoms of Developmental Coordination Disorder (DCD). The main questions it aims to answer are:

1. 1.Will children with DCD who undergo intensive sensory stimulation therapy show greater improvement in upper limb motor function compared to those receiving standard therapy?
2. 2.Will intensive sensory stimulation therapy lead to better sensory function outcomes, including joint position sense, resistance sense, pressure sense, temperature perception, and two-point discrimination? Researchers will compare children receiving intensive sensory stimulation therapy to those receiving standard therapy without intensive sensory stimulation to see if the targeted intervention results in superior improvements in motor and sensory function.

Conditions

Developmental Coordination Disorder

Keywords

developmental coordination disorder; sensory function; motor function; sensory stimulation; adolescents

Outcome Measures

Primary Outcomes (6)

• The Jebsen-Taylor Hand Function Test (JTHFT)

  The JTHFT (Jebsen et al. 1969, Fabbri et al. 2021) is a standardized assessment tool used to evaluate the hand function of individuals, particularly in clinical settings. This test is particularly relevant for assessing fine motor skills and the ability to perform tasks that require both coordination and dexterity. The tasks include: Writing a Sentence: Assesses the ability to hold a pen and write legibly. Turning Over Cards: Tests finger dexterity by flipping a set of cards one at a time. Picking Up Small Objects: Evaluates the ability to manipulate small items, often using a pre-defined set of objects. Simulated Feeding: Involves using utensils to demonstrate the ability to eat. Stacking Checkers: Measures the manipulation of objects by stacking them. Lifting a Paper Clip: Assesses fine motor skills by picking up a small, light object.

  From enrollment to the end of treatment at 4 weeks

• Joint Position Sense

  Joint position sense is assessed using active reproduction and position differentiation tests. In reproduction, the participant memorises a target position (90º shoulder abduction) and then attempts to replicate it without visual input. In differentiation, they aim to reach half the target angle (45º). An electronic inclinometer (±1º accuracy) fixed to the upper arm measures angles. Markers are placed on anatomical landmarks, and a goniometer is secured parallel to the humeral axis. Tests are performed seated. The target position is passively assumed under supervision and memorised (×3). The participant then reproduces or differentiates the angle (×2 each), confirming with "stop." Readings are taken after each attempt. Both sides are tested. The absolute positioning error (absolute difference between target and assumed angles) is used for analysis, based on the mean of two measurements.

  From enrollment to the end of treatment at 4 weeks

• Sense of Resistance

  Resistance sense is assessed using force reproduction and differentiation tests. In the first, the participant replicates a memorised reference force; in the second, they generate half that force. An electronic dynamometer (±0.1 kG accuracy) is attached to a 12 cm sleeve on the upper arm and connected to the floor via an elastic cord. Tests are conducted in 90º shoulder flexion or abduction. The reference force is defined as the effort needed to stretch the elastic cord slightly for 5 seconds. After adjustments, this is repeated three times, and the participant memorises the force. Then, with eyes closed, they reproduce or halve the force, confirming with "stop." The examiner records the values. Each test is repeated three times. Two extremities are tested. The absolute force generation error (normalised difference in %) is used for analysis, based on the mean of three measurements.

  From enrollment to the end of treatment at 4 weeks

• Sense of Pressure

  Pressure sense is assessed at 5 fixed points on the chest, upper limb, and scapular region, corresponding to different peripheral nerve branches. The test is performed in supine or prone position, depending on the site, with the upper limb abducted to 90º. An algometer is used to apply focused pressure and record force. It has a blunt tip with a 20 mm² contact area and measures with ±0.1 kG accuracy. During testing (eyes closed), the participant says "stop" when pressure at a point becomes uncomfortable but not painful. The examiner records the force at that moment. Each point is tested twice. Pressure is applied perpendicularly to the skin, and both sides are assessed. The maximum applied force does not exceed 6 kG to avoid subcutaneous bruising. The final result is the average of the two measurements.

  From enrollment to the end of treatment at 4 weeks

• Discriminative Sense

  Discriminative sense is tested at 5 fixed points on the chest, upper limb, and scapular area - same as in the pressure sense test. A calliper with two rounded tips is used, with a measurement accuracy of 0.5 mm. With the participant's eyes closed, the examiner applies both tips to the skin and gradually reduces the distance between them. The participant reports whether they feel one or two touch points. When they begin to perceive only one while two are still applied, the distance is recorded. This is repeated twice. The calliper arms are held perpendicular to the skin without added pressure - only the instrument's own weight acts on the surface. One arm always remains at a fixed point, while the other approaches from the side or from distal direction, depending on the location. Both sides of the body are tested. The final result is the average of the two measurements.

  From enrollment to the end of treatment at 4 weeks

• Sense of Temperature

  Temperature sense is assessed at 5 fixed points on the chest, upper limb, and scapular area, as in the pressure test. A custom-built device with a 3 cm² flat thermal head, heat converter, and digital thermometer is used, offering ±0.5ºC accuracy and precise heat control. With eyes closed, the participant detects a change in temperature. The test begins with the head at neutral temperature (30ºC), increasing steadily at 1ºC every 10 seconds. The participant says "stop" when they notice a temperature change, and the examiner records the reading. Each point is tested twice. A tolerance test is performed beforehand to define each participant's discomfort threshold. The stimulus never exceeds 45ºC. Both sides of the body are assessed. The final result is the average of the two measurements.

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

Standard therapy without intensified tactile stimulation

ACTIVE COMPARATOR

Intervention: Passive and active therapy without high sensory stimulation Duration: 4 weeks Frequency: 3 sessions per week Session duration: 60 minutes Intervention structure:

Other: Active and passive physical therapy without intensified sensory stimulation

Therapy with intensified tactile stimulation

EXPERIMENTAL

Intervention: Passive and active therapy incorporating high sensory stimulation Duration: 4 weeks Frequency: 3 sessions per week Session duration: 60 minutes

Other: Active and passive physical therapy with intensified sensory stimulation

Interventions

Active and passive physical therapy without intensified sensory stimulation OTHER

Intervention: Passive and active therapy without high sensory stimulation Duration: 4 weeks Frequency: 3 sessions per week Session duration: 60 minutes Intervention structure: Passive therapy (30 minutes): • Stroking and rubbing techniques from classic massage applied in the area of arm forearm and hand with low force and frequency upper limb massage - 15 minutes per limb Active therapy (30 minutes): upper limb muscle strengthening exercises (without globalized vibration); difficulty level individually adjusted to meet participants' current potential, so that in the last sets/reps little manual assistance from the therapist is needed: * Supine pull-ups - 3 sets of 8 reps, \~45 seconds rest between sets * Standing pull-ups - 3 sets of 8 reps, \~45 seconds rest between sets * Standing push-ups - 3 sets of 8 reps, \~45 seconds rest between sets * Standing elbow extensions - 3 sets of 8 reps, \~45 seconds rest between sets

Standard therapy without intensified tactile stimulation

Active and passive physical therapy with intensified sensory stimulation OTHER

Intervention: Passive and active therapy incorporating high sensory stimulation Duration: 4 weeks Frequency: 3 sessions per week Session duration: 60 minutes Intervention structure: Passive therapy (30 minutes): stimulation of joint receptors, muscle spindles, and tactile pathways: * High-frequency soft tissue mobilisations * Localised high-amplitude vibration (30-50 Hz; Galileo Mano 30, Novotec Medical GmbH) * Deep pressure techniques - Wilbarger brushing protocol followed by joint compressions Active therapy (30 minutes): upper limb and shoulder girdle muscle strengthening exercises with globalized vibration using Redcord Stimula (30-50 Hz; Redcord AS, Norway); difficulty level individually adjusted to meet participants' current potential. Excercises the same as in the control group.

Therapy with intensified tactile stimulation

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• between 12-16 years of age
• diagnosed severe symptoms of the developmental coordination disorder based on The Movement Assessment Battery for Children 2nd Edition (M-ABC 2), with scores ranging from 40 to 50
• typical intellectual development (i.e., children attending mainstream education)
• voluntary participation and informed consent signed by parents or legal guardians

You may not qualify if:

• current or previous diagnosis of serious orthopaedic or neurological conditions (e.g. fractures, congenital deformities, cerebral palsy, etc.)
• history of any surgical procedures
• history of significant musculoskeletal pain or dysfunction lasting more than two weeks and requiring medical or physiotherapeutic intervention, or any such symptoms occurring within one month prior to the study
• any current musculoskeletal dysfunction and/or pain
• body mass index exceeding 22 kg/m³

Sponsors & Collaborators

• The Jerzy Kukuczka Academy of Physical Education in Katowice: lead
• Daugavpils University, Department of Healthcare: collaborator

Study Sites (2)

Daugavpils University

Daugavpils, LV-5401, Latvia

Location

The Jerzy Kukuczka Academy of Physical Education

Katowice, 40-065, Poland

Location

Related Publications (10)

• Keating J, Purcell C, Gerson SA, Vanderwert RE, Jones CRG. Exploring the presence and impact of sensory differences in children with Developmental Coordination Disorder. Res Dev Disabil. 2024 May;148:104714. doi: 10.1016/j.ridd.2024.104714. Epub 2024 Mar 13.

  PMID: 38484422 BACKGROUND

• Law SH, Lo SK, Chow S, Cheing GL. Grip force control is dependent on task constraints in children with and without developmental coordination disorder. Int J Rehabil Res. 2011 Jun;34(2):93-9. doi: 10.1097/MRR.0b013e32833f0519.

  PMID: 21178635 BACKGROUND

• Elbasan B, Kayihan H, Duzgun I. Sensory integration and activities of daily living in children with developmental coordination disorder. Ital J Pediatr. 2012 Apr 30;38:14. doi: 10.1186/1824-7288-38-14.

  PMID: 22546072 BACKGROUND

• Tran HT, Li YC, Lin HY, Lee SD, Wang PJ. Sensory Processing Impairments in Children with Developmental Coordination Disorder. Children (Basel). 2022 Sep 22;9(10):1443. doi: 10.3390/children9101443.

  PMID: 36291382 BACKGROUND

• American Psychiatric Association. Diagnostic and statistical manual of mental disorders (5th ed.). Arlington: American Psychiatric Publishing, 2013.

  BACKGROUND

• Lachambre C, Proteau-Lemieux M, Lepage JF, Bussieres EL, Lippe S. Attentional and executive functions in children and adolescents with developmental coordination disorder and the influence of comorbid disorders: A systematic review of the literature. PLoS One. 2021 Jun 4;16(6):e0252043. doi: 10.1371/journal.pone.0252043. eCollection 2021.

  PMID: 34086687 BACKGROUND

• Zwicker JG, Missiuna C, Harris SR, Boyd LA. Developmental coordination disorder: a review and update. Eur J Paediatr Neurol. 2012 Nov;16(6):573-81. doi: 10.1016/j.ejpn.2012.05.005. Epub 2012 Jun 15.

  PMID: 22705270 BACKGROUND

• Missiuna C, Gaines R, McLean J, Delaat D, Egan M, Soucie H. Description of children identified by physicians as having developmental coordination disorder. Dev Med Child Neurol. 2008 Nov;50(11):839-44. doi: 10.1111/j.1469-8749.2008.03140.x. Epub 2008 Sep 22.

  PMID: 18811713 BACKGROUND

• Fabbri B, Berardi A, Tofani M, Panuccio F, Ruotolo I, Sellitto G, Galeoto G. A systematic review of the psychometric properties of the Jebsen-Taylor Hand Function Test (JTHFT). Hand Surg Rehabil. 2021 Oct;40(5):560-567. doi: 10.1016/j.hansur.2021.05.004. Epub 2021 May 21.

  PMID: 34023565 BACKGROUND

• Jebsen RH, Taylor N, Trieschmann RB, Trotter MJ, Howard LA. An objective and standardized test of hand function. Arch Phys Med Rehabil. 1969 Jun;50(6):311-9. No abstract available.

  PMID: 5788487 BACKGROUND

MeSH Terms

Conditions

Motor Skills Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Anna Gogola, PhD

CONTACT

603112533; a.gogola@awf.katowice.pl

Rafał Gnat, DSc

CONTACT

515957646; r.gnat@awf.katowice.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Statisticians responible for data processing and analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 6, 2025
• Study Start: June 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: April 30, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

LA (1); PL (1)