Influence of Motor Intervention With the Intorus Tool on the Psychomotor Development of Children With Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Berg Equilibrium Scale
研究概览
简要总结
The goal of this clinical trial is to test in people with down syndrome how does the INTORUS tool influence their psychomotor development. The main question it aims to answer is:
- Does the INTORUS tool improve psychomotor development in people with Down Syndrome? The intervention program will be carried out during the Functional Habilitation sessions and will be carried out by the center's professionals. These sessions must be carried out in a quiet environment, without distractions so that the user can concentrate on carrying out the activities. It is important that the user attends the sessions in comfortable, sleeveless clothing, to allow the tool to slide smoothly through their upper limbs.
Each session will consist of several exercises with their corresponding rest breaks described in the Intervention Protocol. Each session attendance will be recorded following an attendance record model created for the occasion.
Participants will be divided into two groups randomly. The control group will receive an intervention treatment at the psychomotor level in the traditional way, following the protocols established in the center, and the intervention group will receive an intervention treatment at the psychomotor level with the INTORUS device.
Randomization will be carried out using the Oxford Minimization and Randomization software.
详细描述
POPULATION The population of interest are users of the Functional Habilitation Service of the Centers of the Down Syndrome Association of Cáceres and Plasencia
INCLUSION CRITERIA
- Users with Down Syndrome
- Ages between 4 and 18 years.
- Informed consent signed by parents/guardians.
EXCLUSION CRITERIA
- Users without Down Syndrome.
- Under 4 years and over 18 years.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Users with Down Syndrome
- •Ages between 4 and 18 years.
- •Informed consent signed by parents/guardians.
排除标准
- •Users without Down Syndrome.
- •Under 4 years and over 18 years
结局指标
主要结局
Change in Berg Equilibrium Scale
时间窗: Before starting the interventions, at 3 months and at 6 months at the end of the study.
Scale for measuring balance in people over 15 years of age. The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
Change in Pediatric Balanced Scale
时间窗: Before starting the interventions, at 3 months and at 6 months at the end of the study.
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points
次要结局
- Change in Harris test(Before starting the interventions, at 3 months and at 6 months at the end of the study.)
研究者
Blanca González Sanchez
DOCTOR
University of Extremadura