Evaluation of Robotic Exoskeletons Therapy for Gait Rehabilitation in Patients With Incomplete Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Lower extremity motor score
研究概览
简要总结
The objective of the study is to assess the efficacy of the Exo-H2 robotic exoskeleton for walking rehabilitation of people with incomplete spinal cord injury.
详细描述
The recovery of walking ability is a primary concern of rehabilitation programs for people who have suffered anincomplete spinal cord injury. Robotic therapy arises from the new concepts of neuroplasticity. One of the most novel contributions in this field is robotic exoskeletons. However, there is still not enough scientific evidence to support the clinical use of this technology.
The aim of this proposal is to assess the efficacy of a new model of robotic exoskeleton (Exo H2) developed by the CSIC with HNP involvement in the context of HYPER project (Consolider 2009 call) in gait rehabilitation for people with incomplete spinal cord injury. A multicenter study is proposed here, involving the National Hospital of Paraplegics and the Institut Guttmann. Two randomized groups of patients with subacute incomplete spinal cord injury will be defined. In one group, protocol gait rehabilitation based on the Exo H2 will be established and traditional gait therapy will be adapted for control group. Both groups of patients were assessed performing a physical exam including functional gait scales (10 MWT, 6MWT, WISCI II score, SCIM) and a biomechanical gait analysis with kinetic and kinematic techniques. Functional assessment will be carried out before intervention, at the end of the intervention and a follow up six weeks later.
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
- Single (Outcomes Assessor)
盲法说明
The evaluator does not have information on the group the patient was enrolled.
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Incomplete Spinal Cord Syndrome, ASIA scale C or D
- •enough strength in the upper extremities to handle a walker or crutches (triceps brachial muscle balance ≥ 3)
- •Age between 16 and 70 y.o.
- •Heigth: 1.6-1.9m
- •Weigth less than 120Kg
- •Stable medical condition between 6 weeks and 18 months since injury.
- •Subjects must tolerate standing and be included in walking rehabilitation program in the center.
- •Lower limb spasticity should be lower than 3 as measyred by Ashworth scale.
排除标准
- •Cardiovascular diseases.
- •Upper limb pathology of any kind.
- •irreducible flexo or arthrodesis in lower limb joints, 2 or more osteoporotic fractures in the lower limbs in the last 2 years
- •Uncontrolled epilepsy.
- •Ulcers sores at the contact points with the exoskeleton.
- •Refuse to participate.
结局指标
主要结局
Lower extremity motor score
时间窗: Change from Baseline Lower Extremity Motor Score at 2 months
This scale evaluate the ability and force of the patient when attepmting to contract five key lower limb muscles. It is manually measured by the therapist. Range from 0 (no contraction) to 5 (healthy function). The total score summs up the scores of all muscles. In healthy conditions is 50 points.
Six minutes walking test
时间窗: Change from Baseline Six Minutes Walking Test at 2 months
This test measure walking endurance by measuring the distance covered in six minutes of walking in flat, straigth line.
Time Up-and-Go Test (TUG)
时间窗: Change from Baseline TUG Test at 2 months
This test measures the time to complete stand to sit, walk 3 meters and sitting back again.
Spasticity measured by Ashworth scale
时间窗: Change from Baseline Ashworth Scale at 2 months
Manual testing of muscle tone in response to manual mobilization of joints. Range from 0 (healthy response) to 4 (maximum muscle tone).
Ten meters walking test
时间窗: Change from Baseline Ten Meters Walking Test at 2 months
This test measure walking velocity on covering ten meters walking in flat, straigth line.
Walking Index for Spinal Cord Injury II (WISCI II)
时间窗: Change from Baseline WISCI II Scale at 2 months
WISCI II assess the amount of physical assistance needed, as well as devices required, for walking following paralysis that results from Spinal Cord Injury. The subject is observed by the trained personnel and the WISCI level is recorded on the scale of 0 to 20 at baseline (Baseline WISCI). The subject is observed again at the defined interval (Interval WISCI). The change in score is calculated by subtracting the baseline WISCI from the Interval WISCI, which equals the change in WISCI (Changed WISCI). If a group of subjects are enrolled, medians and means may be calculated.
Questionnaire: Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
时间窗: Through study completion
The purpose of the QUEST questionnaire is to evaluate how satisfied you are with your assistive device and the related services you experienced. The questionnaire consists of 12 satisfaction items. For each of the 12 items, rate your satisfaction with your assistive device and the related services you experienced by using the following scale of 1 to 5.
次要结局
- Spinal Cord Independence Measure III (SCIM III)(Change from Baseline SCIM III scale at 2 months)
研究者
Angel Gil-Agudo
PhD, MD, Head of Rehabilitation
Hospital Nacional de Parapléjicos de Toledo