ABLE Exoskeleton vs KAFO Orthosis: Comparative Study of Gait Kinematics and Energy Efficiency in Patients With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Measurement of gas exchange during 6 Minute Walk Test (6 MWT)
研究概览
简要总结
This randomized crossover study will compare walking with KAFO type orthoses (current standard of care) versus the ABLE Exoskeleton device, during walking in patients with spinal cord injury in a hospital setting. The ABLE Exoskeleton is a robotic exoskeleton that actively assists individuals with mobility problems to stand up, walk and sit down.
The main objective of the study is to compare the energy efficiency during gait with both devices. Secondary objectives are: compare gait kinematics, usability, user's satisfaction, physical activity and psychosocial impact. The study will also serve to evaluate the usability and safety of the ABLE Exoskeleton in clinical practice.
Subjects will complete 10 gait training sessions during a 5-week period with 1 of the 2 devices randomly selected, followed by a post-training assessment consisting of 1 session. Once the test is completed, subjects will have a 2-week rest period after which they will repeat the process with the other device for 5 weeks (followed by 1 post-training assessment session). The study will be conducted at Hospital Asepeyo Barcelona in Spain, where a total of 10 patients will be recruited.
详细描述
The primary objective of this study is determining the energy efficiency through gases exchange and kinematic gait analysis to compare the standard of assistance (KAFO type orthoses) and the ABLE Exoskeleton, a robotic gait assistance device, in patients with spinal cord injury (SCI) in a hospital setting.
The secondary objectives are to compare the performance of KAFO-type orthoses with that of the ABLE Exoskeleton device by:
- Kinematic analysis of gait and spatiotemporal gait parameters.
- Evaluation of the time and effort required to learn to use the device (usability).
- Evaluation of the impact that physical activity has on participants after gait training.
- Evaluation of the level of satisfaction of the participants.
In addition to these objectives, the safety of the ABLE Exoskeleton as an assistive device for gait rehabilitation in SCI patients will be evaluated throughout the study.
Participants will perform 2 training sessions per week of approximately 90 minutes duration for 5 weeks with each of the devices, completing a total of 10 sessions with KAFO type orthoses and 10 sessions with the ABLE Exoskeleton. Before starting the training period, the physical capacity of the participants will be measured. During the training period sessions, different measurements of the level of assistance, spatiotemporal gait variables and usability will be taken. Standardized clinical assessments will also be performed during sessions 5 and 10 (assessment sessions). At the end of the training period, a post-training assessment will be performed, consisting of 1 session where the physical capacity of the participants will be measured. After finishing the training period with one of the devices, participants will have a rest period of 2 weeks, after which they will change devices and repeat the whole process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •From 18 to 70 years old
- •Chronic or subacute spinal cord injury.
- •Currently in treatment as in-patient or ambulatory in the investigational site.
- •From AIS A to AIS D with enough arm strength to withstand the bodyweight in a walking frame.
- •Previous experience walking with KAFO orthoses (must tolerate standing).
- •Ability to give informed consent
排除标准
- •WISCI II >16 without the exoskeleton.
- •5 or more fragility fracture risk factors according to Craven et al.
- •History of fragility fractures of lower limbs in the past 2 years.
- •Deterioration > 3 points of the total International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor score within the last 4 weeks.
- •Spinal instability
- •Modified Ashworth scale (MAS) > 3 in lower limbs
- •Unable to tolerate 30 minutes standing without clinical symptoms of orthostatic hypotension.
- •Unable to walk 5 meters with KAFO orthoses and the support of a walking frame with wheels.
- •Psychological or cognitive issues that do not allow a participant to follow the study procedures.
- •Any neurological condition other than SCI
- •Medically unstable
- •Severe comorbidities including any condition that a physician considers to not be appropriate to complete participation in the study.
- •Ongoing skin issues
- •Height, width, weight or other anatomical constraints (such as leg length differences) incompatible with the device
- •Insufficient Range of Motion (ROM) for ABLE Exoskeleton device
- •Known pregnancy or breastfeeding
结局指标
主要结局
Measurement of gas exchange during 6 Minute Walk Test (6 MWT)
时间窗: Session #5, Session #10. Sessions take place 2x/week over a 5 week training period.
6 Minute Walk Test (6 MWT) measures the distance a person can walk in 6 minutes. There are different possibilities for performing this test. For this study, we will use a track of at least 10 meters, where patients walk back and forth.
Measurement of gas exchange during the Timed Up and Go Test (TUG)
时间窗: Session #5, Session #10. Sessions take place 2x/week over a 5 week training period.
Timed Up and Go Test (TUG) measures the time it takes a person to get up from a chair, walk 3 meters, turn around and sit down again. It is a widely used test to assess balance and the risk of falls in different patient groups.
Measurement of gas exchange during Graded exercise testing (GXT)
时间窗: Change from preliminary assessment through study completion, an average of 16 weeks.
Maximal Graded Exercise Test (GXT) is a screening tool to track an individual's fitness level. The test evaluates the participant's exercise capacity by measuring the cardiovascular response to physical activity. Through this test, the values of maximal oxygen consumption will be obtained and used to obtain metrics to assess energy efficiency during the gait.
Measurement of gas exchange during 10 Meter Walk Test (10MWT)
时间窗: Session #5, Session #10. Sessions take place 2x/week over a 5 week training period.
The 10 Meter Walk Test (10 MWT) measures the time a person needs to walk 10 meters. The test is performed with a dynamic (flying) start with two-meter acceleration, a timed ten-meter distance and two-meter deceleration.
次要结局
- Measurement of the Level of Assistance to perform therapy activities.(Up to 5 weeks)
- Perceived level of exertion(Up to 6 weeks)
- Fatigue Visual Analog Scale (VAS)(Up to 6 weeks)
- Spinal Cord Independence Measure (SCIM) III(Up to 10 days before first session and up to 10 days after first session)
- Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0)(Up to 6 weeks)
- Psychosocial Impact of Assistive Devices Scales (PIADS)(Up to 6 weeks and followup (4 weeks after study completion).)