Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- 6 Minutes Walking Test (6MWT)
研究概览
简要总结
Gait impairment in people with acquired brain injury (ABI) and spinal cord injury (SCI) can be very heterogeneous. For this reason, STELO has been developed: a new concept of exoskeleton based on modular technology for gait assistance. It allows a personalised configuration according to the functional capacity of each patient, as the therapist can choose which robotic joints to use depending on the therapeutic goal and on the patient recovery phase. The objective is to analyse the usability of the STELO modular exoskeleton in people with ABI and SCI.
详细描述
A test phase will be conducted in healthy volunteers as a proof of concept with the aim of evaluating safety and usability in healthy participants prior to the use of the device in the ABI or SCI population (Phase 2).
After verifying that the device is safe in healthy people, phase 2 will begin: it consists of a total of 10 visits. These visits will include gait training sessions using the STELO modular exoskeleton.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Weight < 100 kg.
- •Height 150-190 cm.
- •Hip width between 30 - 45 cm.
- •Distance from hip joint centre to knee joint centre: 36 cm - 50 cm.
- •Distance from the centre of the knee joint to the ground: 43.5 - 59.5 cm.
- •Shoe size EU 36-
- •Patients must be able to follow simple commands.
- •Age 18-85 years.
- •Diagnosis of ABI or SCI.
- •FAC level in participants with ABI <
- •WISCI II level in participants with SCI < 20.
排除标准
- •Spasticity (MAS) = 4 in lower limbs.
- •Skin alterations in the areas of contact with the device.
- •Planned surgical intervention during the duration of the study.
- •Two or more osteoporotic fractures in the lower limbs in the last 2 years.
- •Presence of other pathologies causing exercise intolerance (such as uncontrolled hypertension, coronary artery disease, arrhythmia, congestive heart failure, severe pulmonary disease).
- •Surgical operation in the 3 months prior to the start of the study on the limbs and/or spine.
- •Psychiatric disorders that interfere with proper use of the device or participation in the study such as impulsivity or inability to understand simple commands.
结局指标
主要结局
6 Minutes Walking Test (6MWT)
时间窗: In all sessions during 6 weeks.
Distance covered using the device in 6 minutes
Device malfunction
时间窗: In all sessions during 6 weeks.
Number and type of device malfunction
Skin integrity
时间窗: Through study completion, an average of 100 days
Assess the size (centimetres) of the skin tag produced after use of the exoskeleton.
Kinematic gait analysis
时间窗: Once during the first session.
Assessed by photogrammetry (VICON) in a gait analysis laboratory in healthy subjects
Functional Ambulation Categories
时间窗: In all sessions during 6 weeks.
ABI participants
Physiotherapist's satisfaction (Therapist Satisfaction Scale)
时间窗: At the end of the study, 6th week
It will be assessed using Therapist Satisfaction Scale
SF-12
时间窗: At the end of the study, 6th week
Quality of life
Pain (Visual Analogic Scale)
时间窗: Through study completion, an average of 100 days
Pain registered before and after the use of the device, by the participant and therapist. The options are from 1 to 6. A higher score means a worse outcome. Pain registered before and after the use of the device, by the participant and therapist. The options are from 1 to 6. A higher score means a worse outcome.
Fall prevalence
时间窗: During the use of the device, for 6 weeks.
Number of falling events ocurred from the participant or therapist.
10 Meters Walking Test (10MWT)
时间窗: In all sessions during 6 weeks.
Time to cover 10 meters using the decvice.
Time and assistance with device attachment and removal
时间窗: In all sessions during 6 weeks.
Time taken in minutes to fit and remove the participant's device.
Walking Index for Spinal Cord Injury (WISCI)
时间窗: In all sessions during 6 weeks.
SCI participants
User perception of the device (QUEST 2.0)
时间窗: At the end of the study, 6th week
QUEST 2.0 will be assessed by the participant
Diastolic blood pressure
时间窗: Through study completion, an average of 100 days
Assesment of diastolic blood pressure in mmHg
Participant's satisfaction of the device (Participant Satisfaction scale).
时间窗: At the end of the study, 6th week
It will be measured through Participant Satisfaction scale.
Heart rate
时间窗: Through study completion, an average of 100 days
Assessment of heart rate (beats/min)
Oxygen saturation
时间窗: Through study completion, an average of 100 days
% O2
Systolic blood pressure
时间窗: Through study completion, an average of 100 days
Assesment of systolic blood pressure in mmHg
Muscular activation
时间窗: Once during the first session.
Assessed by electromyography (NORAXON).
Timed Up and Go (TUG)
时间窗: In all sessions during 6 weeks.
Distance to go 3 metres, turn around and sit on a chair.
次要结局
- Accesssibility(At the end of the study, 6th week)
- Acceptability(At the end of the study, 6th week)