Estudio Piloto de Una Serie de Casos Para Evaluar el Efecto Rehabilitador Del Uso de un Exoesqueleto de Marcha en Pacientes Con patología Neuromuscular o parálisis Cerebral
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Revised Upper Limb Module (RULM)
研究概览
简要总结
The purpose of this multicentric study is to assess the rehabilitative effect derived from the use of the ATLAS exoskeleton in children with neuromuscular diseases or cerebral palsy and with a level of less than 3 or less in the Functional Ambulation Classification (FAC) as a consequence of their disease, as well as the assessment of other physical, functional and quality of life parameters of interest. For this purpose, the exoskeleton will be used as a rehabilitation and walking assistance tool.
Before starting the study programme and if deemed necessary, a preliminary phase consisting of 1 to 3 sessions will be carried out during which the patient will be shown the exoskeleton for the first time and it will be considered whether any improvements to the different parts of the device or the software are necessary to increase the ergonomics and comfort of the patient.
详细描述
The objectives of the study are:
- Objective 1: To assess the safety and physical and physiological tolerance of the child to the activity performed with the exoskeleton in the rehabilitation sessions.
- Objective 2:
- To assess the safety of a progressive treatment algorithm to achieve the safe progression of patients throughout the therapy
- To assess whether an improvement is achieved in parameters related to the physical rehabilitation of the patient using the exoskeleton, in respiratory capacity, self-perceived quality of life (physical and emotional well-being and self-esteem) as well as to assess the effectiveness of a psychological intervention to provide support in coping with the situation of using the device for the first time in those children who have not used it before.
The time period of the study will be as long as necessary to reach the desired number of participants, in this case 10 children (N=10). The participants will be patients affected by neuromuscular diseases or cerebral palsy and will be selected on the basis of the following inclusion/exclusion criteria:
Inclusion criteria: 1. Children with neuromuscular disease or cerebral palsy who present gait disturbances or no gait disturbance. 2. Children between 3 and 11 years of age.
Exclussion criteria: not fulfil the usage criteria of the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with neuromuscular disease or cerebral palsy who have gait disturbance or no gait.
- •Children between 3 and 14 years of age.
排除标准
- •Weight> 35 kg
- •Femoral length (from the axis of the hip joint in the sagittal plane to the axis of the knee joint in the same plane) <23 cm or >38 cm for size M and from 31 cm to 40 cm for size L
- •Stem length (from the axis of the knee joint in the sagittal plane to the axis of the ankle joint in the same plane) <23 or >32 cm for size M and from or >39 cm for size L
- •Distance between great trochanters <24 or >35 cm for size M and <25 cm or >35 cm for size L
- •Inability to understand simple commands, to cooperate actively in therapy, or inability to express basic needs
- •Spasticity measured with the Modified Ashworth Scale greater than or equal to 3 in the lower limbs
- •Scoliosis > 25° without the possibility of wearing a brace
- •Skin alteration where direct contact between the patient's skin and the exoskeleton is not recommended
- •Limitation of passive range of motion at the knee or hip joint > 20 degrees
- •Osteoporosis that may induce a bone fracture when low intensity physical activity is performed
- •Any other medical condition that may be a risk to the patient's safety and well-being in relation to low intensity physical exercise
结局指标
主要结局
Revised Upper Limb Module (RULM)
时间窗: 3 months
Upper limb quality of movement using RULM scale for Spinal Muscular Atrophy children
Skin integrity
时间窗: 1 day
Skin alterations assessing their localization, size (centimeters), redness and temperature increase.
Expanded Hammersmith Functional Motor Scale
时间窗: 3 months
Motor functionality measured for children with Spinal Muscular Atrophy
Gross Motor Function Measure 88 (GMFM-88)
时间窗: 3 months
Motor functionality measured for children with Cerebral Palsy.
Oxigen Saturation
时间窗: 1 day
Measured in %O2 using vital sign monitor
Quality of life assessment
时间窗: 3 months
Quality of life iof the children measured using the KINDL questionnaire.
The Functional Independence Measure for Children (WeeFim)
时间窗: 3 months
WeeFim scale for CP children.
Fatigue
时间窗: 1 day
Patient fatigue measured by Borg fatigue scale for children ages
Respiratory rate
时间窗: 1 day
Respiratory rate measured manually in breaths per minute using chronometer
Heart rate
时间窗: 1 day
Measured in beats per minute using vital sign monitor
Blood preasure
时间窗: 1 day
measured in mmHg with a sphyngomanometer
Muscular balance
时间窗: 1 month
Strength measured in Newtons with a Hand-Held Dinamometer for elbow flexion, neck lateralization, ankle plantarflexion and dorsiflexion, knee flexion and extension.
Respiratory functional parameters
时间窗: 3 months
Measured by Spirometer (volumes measured in litres and pressures in mmHg)
Joint range of motion
时间窗: 1 month
Range of motion in degrees of hip, knee and ankle movements using a manual goniometer.
Pain assessment
时间窗: 1 day
Patient pain measured by EVA faces scale for children ages
Quality Upper Extremity Skill test (QUEST)
时间窗: 3 months
Upper limb quality of movement using QUEST scale for cerebral palsy children
Egen Klassifikation
时间窗: 3 months
Functional ability measured using EK2 scale for SMA
Peak Flow cough
时间窗: 1 week
Measured in litres per minute using a Peak flowmeter
次要结局
未报告次要终点