The Influence of Intensified Sensory Stimulation on Upper Extremity Sensory Parameters and Motor Function in Children With Developmental Coordination Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- The Jebsen-Taylor Hand Function Test (JTHFT)
研究概览
简要总结
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:
- Will children with DCD who undergo intensive sensory stimulation therapy show greater improvement in upper limb motor function compared to those receiving standard therapy?
- 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.
详细描述
Background Developmental Coordination Disorder (DCD) is a neurodevelopmental condition that affects the development of motor skills in children, impacting their ability to perform a range of daily activities (Missiuna et al., 2008; Zwicker et al., 2012). According to the Diagnostic and Statistical Manual of Mental Disorders (American Psychiatric Association, 2013), DCD is characterized by difficulties in acquiring and executing coordinated movements.
The diagnostic criteria for DCD include motor abilities that are significantly below what would be expected for the individual's chronological age and learning experiences. These motor challenges must interfere substantially with daily living activities, educational or professional achievements, and hobbies. Symptoms typically emerge in early childhood and cannot be better explained by intellectual disability, neurological conditions affecting movement, or visual impairments. Motor difficulties often present as clumsiness, slowness, and inaccuracy in executing movements (Lachambre et al., 2021).
Recent research highlights the high prevalence and significant impact of sensory processing impairments among children with DCD. Studies have identified notable differences across various sensory domains - including visual, tactile, proprioceptive, auditory, and vestibular processing - when compared to typically developing peers (Tran et al., 2022). Children with DCD, for instance, exhibit greater deficits in proprioceptive processing, such as difficulties with localizing single and double simultaneous stimuli, graphesthesia, finger identification (Elbasan et al., 2012; Malloy-Miller et al., 1995), and two-point discrimination under both dynamic and static conditions (Law et al., 2011).
Children with DCD experience pronounced sensory differences that significantly affect their daily functioning. These sensory differences may also signal the presence of additional neurodivergent traits. Furthermore, sensory processing impairments are closely associated with poor motor coordination and have a substantial impact on daily activities (Keating et al., 2024).
Design and hypotheses The planned study is a randomised controlled trial (RCT) aimed at evaluating the effectiveness of intensive sensory stimulation therapy on upper limb motor skills and sensory function in children with pronounced symptoms of DCD, as assessed by The Movement Assessment Battery for Children - Second Edition (MABC-2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Statisticians responible for data processing and analysis
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The Jebsen-Taylor Hand Function Test (JTHFT)
时间窗: From enrollment to the end of treatment at 4 weeks
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.
Joint Position Sense
时间窗: From enrollment to the end of treatment at 4 weeks
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.
Sense of Resistance
时间窗: From enrollment to the end of treatment at 4 weeks
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.
Sense of Pressure
时间窗: From enrollment to the end of treatment at 4 weeks
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.
Discriminative Sense
时间窗: From enrollment to the end of treatment at 4 weeks
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.
Sense of Temperature
时间窗: From enrollment to the end of treatment at 4 weeks
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.
次要结局
未报告次要终点