跳至主要内容
临床试验/NCT07040722
NCT07040722招募中不适用

Effects of the Use of an Immersive Virtual Reality Device on Handwriting in Children Aged 6 to 13 With Handwriting Difficulties : a Randomized Multiple Baseline Single-case Experimental Design (SCED)

Fondation Ildys9 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
12
试验地点
9
主要终点
Evaluation of the impact of immersive virtual reality training on learning using the Evaligo score.

研究概览

简要总结

Difficulties in learning to write affect a large number of children and can have a significant impact on their personal and professional future. To facilitate this learning process, develop fun, motivating and effective devices for the different skills involved in writing (motor skills, postural control, visual attention, letter recognition) is needing. Virtual Reality (VR) seems to be a promising tool for this purpose.

The SCED (Single Case Experimental Design) methodology is adapted to this study to evaluate the impact of VR on learning to write, as it allows a high level of evidence and is applicable to a heterogeneous population such as that affected by difficulties in learning to write. The study will include an original study of 3 children and 3 replications of 3 children each. In total, 12 children will be included in four different settings. This study will determine whether VR training can facilitate learning to write.

The main objective of this study is to evaluate the impact of immersive virtual reality training on handwriting using the Evaligo tool to assess static, kinematic and pressure parameters of handwriting in children aged 6 to 13 with handwriting difficulties according to a SCED methodology.

详细描述

5% to 30% of children in mainstream education experience difficulties with writing acquisition. This prevalence increases among children with motor disabilities such as cerebral palsy, coordination disorders, or attention-deficit/hyperactivity disorder. Writing difficulties can significantly impact other core learning areas, as well as children's development and future (e.g., increased risk of academic failure, reduced access to higher education, lower self-esteem).

These writing difficulties are multifactorial and require individualized intervention. Fine motor skills, postural control, and visual attention-key abilities in the learning of writing-are often impaired in children with writing difficulties.

Virtual reality (VR) can be defined as the digital simulation of a virtual environment with which users can interact through their own movements. In immersive VR, users wear a head mounted display (HMD) that allows them to be fully immersed in the virtual environment.

VR has been shown to improve upper limb function and postural control in pediatric rehabilitation. It integrates several features that support motor learning, including task repetition, sensory feedback, and enhanced motivation during exercises.

Using VR training to target skills associated with writing thus appears to be relevant. Furthermore, proposing writing training through gross motor activities in VR may facilitate the consolidation of motor programs necessary for letter formation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
6 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age : 6-13 years
  • BHK: degradation score ≥ 1 standard deviation. The BHK will be administered at the time of the inclusion visit (V1) and/or child with writing difficulties in in daily activities.
  • Children benefiting or to benefit from rehabilitation care to improve handwriting skills.
  • Be able to understand instructions and complete all assessments.

排除标准

  • Contraindications to using a virtual reality HMD
  • Severe visual impairment
  • Facial injury
  • Lack of parental and/or child consent

结局指标

主要结局

Evaluation of the impact of immersive virtual reality training on learning using the Evaligo score.

时间窗: This score will be assessed twice a week during the baseline and intervention periods (10 to 14 weeks depending on the baseline).

The Evaligo score assesses static, kinematic and pressure parameters of handwriting in children aged 6 to 13 with handwriting learning difficulties, using a SCED methodology. This assessment has several advantages in this study design: its validity has been verified, it can be repeated a large number of times without test-retest effect, it is sensitive to change and is quick to set up (around 5 minutes), which reduces the burden of assessments for the participating children and therapists. • This score is obtained on the basis of a brief evaluation of around 5 minutes (and repeated, according to the SCED methodology) of trained items (during the intervention), throughout participation in the research (baseline, intervention). The minimum score is 0 (worst), the maximum score is 1 (best).

次要结局

  • Assess fine and gross motor skills(This criterion will be measured (during the first week of the baseline), during the first week of intervention (V2), and the visit at the 8th of the inetervention (V5))
  • Assess visual attention(The criterion will be measured during the first week of the baseline, during the first week of intervention (V2), and the visit at the 8th of the intervention (V5).)
  • Assess postural control(The criterion will be measured during the first week of the baseline, during the first week of intervention (V2), and the visit at the 8th of the intervention (V5).)
  • Determine whether a generalization of learning to write takes place on the paper/pencil writing activity.(The BHK will be taken at the first week of the baseline and at the 8th week of the intervention (V5).)
  • Check that the child's motivation is maintained during training.(Analog scale score at the end of each session, during baseline and intervention (10 to 14 weeks depending on the baseline).)
  • Assess satisfaction with the intervention : CSQ-8(Assessment carried out at the 8th week of the intervention.)
  • Assess satisfaction with the intervention(Evaluation carried out at 8th week of the intervention.)
  • Evaluate the usability of the solution(Evaluation carried out at 8th week of the intervention)
  • Assess the child's sense of presence in the virtual environment(Evaluation carried out at the first session of the intervention phase (Session 1 of the intervention phase), and at the last session pf the intervention phase (Session 16 of the intervention phase).)
  • Assessing language levels : letter recognition(The language levels will be measured during the first week of the baseline, during the first week of intervention (V2), and the visit at the 8th of the intervention (V5))
  • Assessing language levels : knowledge of letter names(The language levels will be measured during the first week of the baseline, during the first week of intervention (V2), and the visit at the 8th of the intervention (V5))
  • Assessing language levels : writing a letter(The language levels will be measured during the first week of the baseline, during the first week of intervention (V2), and the visit at the 8th of the intervention (V5))
  • Assessing language levels : recognition of allographs(The language levels will be measured during the first week of the baseline, during the first week of intervention (V2), and the visit at the 8th of the intervention (V5))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (9)

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