Feasibility of the ANDAGO System in Pediatric Neurorehabilitation: Bridging the Gap From Treadmill-based to Over-ground Walking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- ANDAGO-1: Score on the settings questionnaire
研究概览
简要总结
In this feasibility study, the researchers would like to investigate whether it is feasible to apply the ANDAGO V2.0, a new mobile robot for body-weight supported gait training (developed by Hocoma AG) to children and adolescents undergoing neurorehabilitation. The investigators will explore several outcomes and will compare some outcomes between the children and adolescents when they walk in the ANDAGO or with their regular walking aids.
详细描述
Background and Rationale:
Children with neurological diagnoses including congenital or acquired brain lesions often have impaired lower extremity function limiting the independence in daily life activities. Achieving the ability to stand and walk independently is mentioned by most children and their parents as the highest priority for the neurorehabilitation process. Robotic gait therapy can deliver high-dosage (i.e. number of practice movements) and high-intensive (i.e. number of movements per unit time) training interventions to complement conventional treatments. Nevertheless, there is a gap between treadmill-based gait training and free walking. HocomaAG (Volketswil) developed a new mobile robot for body-weight supported gait training. ANDAGO will bridge this gap while offering a safe and functional environment for patients. Now, the researchers would like to investigate whether it is feasible to apply this prototype to children and adolescents undergoing neurorehabilitation.
Objective(s):
As the device has not been applied in a pediatric rehabilitation setting yet, the researchers want to investigate:
- Feasibility: the investigators will examine technical features as well as patient-related aspects, safety and operability of the device during static (standing) and dynamic (walking) tasks.
- Differences in static and dynamic tasks when standing/walking in the ANDAGO or when being supervised by a therapist.
- Investigate the handling of the ANDAGO. Patients will have time to practice with the device and Background and Rationale:
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
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>1.35 meter
- •Neurological diagnosis
- •Orthopaedic diagnosis
排除标准
- •Surgery or Botox injection of leg muscles during the last 3 months
- •Bone fragility (e.g. non-consolidated fractures or osteotomies including craniotomies, osteopenia, osteoporosis or symptoms or indices in the patient history that infer a higher risk of bone density reduction)
- •Unstable arthroplasty
- •Uncontrolled knee or ankle instability that would still pose a danger despite the BWS (especially lateral instability)
- •Lack of head control
- •Joint contractures
- •Skin lesions (including pressure sores) in areas of contact with harness support or lower extremity loading (feet)
- •Sensory impairment in the lower limbs and trunk, especially with reduced pain sensation
- •Risk of autonomic dysreflexia (level at or above T6; history of autonomic dysreflexia increases the risk of having a reoccurring episode)
- •Recent history or elevated risk of seizures
- •Cardiac conditions, e.g. cardiac insufficiency and thoracotomy, uncontrolled orthostatic hypotension or other circulatory problems, vascular disorders of the lower limbs
- •Cognitive deficits limiting communication
- •Uncooperative or (self-)aggressive behaviour (e.g. transitory psychotic syndrome)
- •Mechanical ventilation
- •Long-term infusions (e.g. baclofen pump, Sacral Anterior Root Stimulation (SARS), intrathecal pumps...)
- •Any medical condition preventing active rehabilitation (e.g. respiratory disease, pregnancy, orthopaedic conditions, psychiatric conditions, infections or inflammatory disorders, osteomyelitis...)
结局指标
主要结局
ANDAGO-1: Score on the settings questionnaire
时间窗: up to 24 weeks
The Settings questionnaire is a self-developed tool, which covers the following areas: * Height of suspension * amount of unloading left/right * handrails * size of the harness and cuffs * fall Limit * Training mode * Maximum velocity * turning offset
ANDAGO-2: Position in the ANDAGO device
时间窗: up to 24 weeks
Can the patient be positioned well in the ANDAGO? If not, what are the causes? This information is collected for general positioning in the device, fitting of harness and leg "cuffs", both with and without unloading. Furthermore it is asked whether positioning is comfortable for the patient (with or without unloading) and whether there were problems in adjusting parameters like patient lift up and down, bodyweight support, unloading uni- or bilateral. Are there problems in getting the child out of the ANDAGO and did situations occur when patient or therapists needed to press the emergency button?
The Edinburgh Visual Gait Score
时间窗: up to 24 weeks
The quality of gait pattern of patients will be assessed within ANDAGO and compared to the walking pattern. Video recordings will be made from the patient and scored according to the Edinburgh Visual Gait Score, which proved one of the most valid and reliable assessments to quantify the quality of the walking pattern. The Edinburgh Visual Gait Score is the sum of the 17 items.
ANDAGO-3: Accuracy of bodyweight support
时间窗: up to 24 weeks
The ANDAGO might also be used as a safety system enabling patients to train their standing balance. The researchers will instruct patients to shift their weight as far as possible from the right to the left leg and from anterior to posterior, 5 times in the ANDAGO and 5 times under supervision of a therapist. The investigators will document changes in center of pressure parameters (medio-lateral and anterior-posterior direction), subjective feeling of safety (ordinal smiley scale 1-5), number of "falls" and whether the task could actually be performed or not. Furthermore they report whether the ANDAGO might have limited the exercise and whether the therapist had to intervene during the exercise.
ANDAGO-4: Dynamic obstacle task
时间窗: up to 24 weeks
Patients will walk in the ANDAGO or with their regular walking aids and perform an obstacle course. Please note, the steps, obstacles etc. are so narrow that the participant in the ANDAGO can step on them, over them, etc., but the ANDAGO can remain on the flat floor. Participants have to step on a higher surface, a ramp, an uneven surface and over an obstacle. The researchers will assess the time to perform the task, the number of "falls" (patients are secured), subjective feeling of safely (smileys ordinal scale 1-5) and whether the task could be accomplished. Furthermore, they assess whether collisions occurred, whether the ANDAGO limited tasks or whether the therapists needed to intervene.
ANDAGO-5: Dynamic precision task
时间窗: up to 24 weeks
Participants will walk 10 meters straightforward, walk a right and left turn and turn around their axis, with and without the ANDAGO. Measures are the time needed to perform these tasks, the number of "falls", the number of steps, precision and smoothness (only with ANDAGO), subjective feeling of safety and whether the task could be accomplished or not. Furthermore, the researchers assess whether collisions occurred, whether the ANDAGO limited tasks or whether the therapists needed to intervene.
次要结局
未报告次要终点
研究者
Huub van Hedel
PD Dr.
University Children's Hospital, Zurich