Efficacy of the INTORUS Device as a Therapeutic Tool in Motor Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- IMPROVEMENT OF UPPER LIMB MOBILITY AS MEASURED BY GONIOMETER
研究概览
简要总结
The goal of this Clinical Trial is to verify the effectiveness of the use of the Intorus device in the motor intervention in patients with cerebral palsy and related syndromes. The main question it aims to answer is:
Does the use of the Intorus tool manage to improve the mobility of upper limbs (MMSS) in patients with infantile cerebral palsy to increase their performance in activities of daily living? A total of approximately 50 users will participate in the study. Participants will be divided into two groups randomly. The control group will receive an intervention treatment at the motor level in the traditional way, following the protocols established in the center, and the intervention group will receive an intervention treatment at the motor level with the INTORUS device.
Randomization will be carried out using the Oxford Minimization and Randomization software.
详细描述
The intervention program will take place during the Occupational Therapy sessions and will be carried out by the center's occupational therapists. 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 patient 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.
EVALUATION
The evaluations will be carried out prior to the start of treatment, at 20 weeks of treatment and at 40 weeks of treatment once the intervention program has concluded.
The tools used to carry out the evaluation will be:
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 infantile cerebral palsy and/or related syndromes.
- •Ages between 4 and 18 years.
- •Motor disability.
- •Affectation in the mobility of upper limbs.
- •Informed consent signed by parents/guardians.
排除标准
- •Patients with another type of pathology not related to cerebral palsy.
- •Under 4 years and over 18 years.
- •Participants who do not meet the inclusion criteria described above
结局指标
主要结局
IMPROVEMENT OF UPPER LIMB MOBILITY AS MEASURED BY GONIOMETER
时间窗: Before starting treatment. After 20 weeks of treatment and at the end of treatment (40 weeks).
Measuring joint amplitude of upper limb joints with goniometer
次要结局
- Functional Gesture of Activities of Daily Living(Before starting treatment. After 20 weeks of treatment and at the end of treatment (40 weeks).)
研究者
Blanca González Sanchez
doctor
University of Extremadura