Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of people assisting the session
研究概览
简要总结
The primary objective of the study is to validate the safety and clinical performance of the ABLE Kids device in pediatric patients with neurological gait disorders or muscular weakness during a 10-session gait training program in a clinical setting.
The secondary objective of the study focuses on obtaining preliminary data on the potential clinical and psychosocial benefits of the product.
详细描述
This is a pre-post, single-center, quasi-experimental study with an estimated duration of 17 weeks. The study will be conducted at Som·hi where a minimum of 10 evaluable participants are expected to be recruited within a period of 11 weeks.
After obtaining informed consent, through the Patient Information Sheet and the Informed Consent Form, the selection of the participants will be carried out to determine their inclusion in the study. Subjects who do not meet all the inclusion and exclusion criteria during the screening visit will be excluded from the study. At the latest, one week after the screening visit, the participants will undergo a baseline assessment without the medical device.
Participants will undergo a 10-session training program with the ABLE Kids device for a maximum duration of 3 weeks. Sessions will be conducted 5 times per week. Each session will last approximately 60 minutes. During the training period, session data will be taken to assess the safety and clinical performance of the device. At the latest, one week after the last training session, a post-training assessment will be performed. Finally, two weeks after the last training session, a follow-up assessment will be made to the participants via a telephone call to review any adverse events (AE) reported between the end of the training and the follow-up.
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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minors with gait impairments, ranging from mild to severe, resulting from neurological conditions or muscular weakness
- •Anthropometric measurements compatible with the use of the exoskeleton, particularly:
- •Weight under 75 kg
- •Height between 1.0-1.5 m
- •Hip: maximum distance between greater trochanters of 35 cm
- •Thigh: maximum distance from trochanter to knee joint line of 36 cm
- •Lower leg: maximum distance from knee joint line to shoe sole of 45 cm
- •Medically stable
- •Intact skin in areas in contact with the device
- •Favorable medical assessment for standing, gait training, and weight-bearing activities
- •Signed informed consent from parents or legal guardians, and assent from the minor whenever possible, according to age and cognitive ability
排除标准
- •Severe spasticity in the lower limbs (Modified Ashworth Scale [MAS] > 3)
- •Severe osteoporosis resulting in atraumatic bone fractures
- •Unhealed fractures or history of fragility fractures in the lower extremities within the past 2 years
- •Unstable or painful hip dislocation (Migration Percentage [MP] > 50%)
- •Symptomatic heterotopic ossification with mechanical limitation or pain
- •Anatomical limitations incompatible with proper fitting and safe use of the device:
- •Leg length discrepancy >1.5 cm in the upper segment or >2.0 cm in the lower segment
- •Severe scoliosis (Cobb angle >40° without the possibility of orthotic use during operation)
- •Inability to achieve proper adjustment within the device
- •Joint range of motion limitations preventing use of the exoskeleton:
- •Knee flexion contracture ≥40°
- •Hip flexion contracture ≥20°
- •Rigid equinus foot
- •Spine or lower extremity surgery within the last 3 months
- •Recently implanted pacemakers
- •Inability to communicate pain, fear, or discomfort (verbally or nonverbally)
- •Daytime mechanical ventilation
- •Uncontrolled epileptic seizures
- •Medical or cardiovascular instability
- •Considered unsuitable by physicians and physiotherapists. Any acute medical condition such as fever, infection, respiratory problems, urinary symptoms, uncontrolled pain, new swelling or redness in the extremities, active deep vein thrombosis, or severe comorbidities considered incompatible with the use of ABLE Kids until clinical resolution
- •Absence of head or trunk control in sitting or standing that cannot be compensated through the use of orthotic support during exoskeleton use
研究组 & 干预措施
Gait training with exoskeleton
Participants will undergo a 10-session gait training program with the exoskeleton, five times a week for up to 3 weeks. Each session will last 60 minutes.
干预措施: ABLE Kids (Device)
结局指标
主要结局
Number of people assisting the session
时间窗: Up to 6 weeks
In each gait training session, the number of people assisting will be recorded
Number of steps walked
时间窗: Up to 6 weeks
In each gait training session, the number of steps taken (step count) with the device will be automatically measured and registered by the device
Distance walked
时间窗: Up to 6 weeks
In each gait training session, the distance walked (in meters) with the device will be automatically measured and registered by the device
Number and type of device-related Adverse Events
时间窗: From baseline to follow-up (up to 2 weeks after end of intervention)
To assess safety, the number of Serious Adverse Events (SAE), Adverse Events (AE) and drop-outs due to the device will be assessed and reported.
Time taken to don/doff the device
时间窗: Up to 3 weeks
The time taken to don/doff the device will be measured in every session. Time will be measured in minutes and seconds for each activity. Donning time will start from the moment the participant is ready to transfer into the device until all the straps and clips are correctly tightened. Doffing time will start from the moment the participant starts taking off the device until they have completely removed it.
Time spent upright and time spent walking
时间窗: Up to 6 weeks
In each gait training session, the time spent upright (in minutes) and the time spent walking (in minutes) with the device will be automatically measured and registered by the device
次要结局
- Lower extremity muscle strenght(At baseline (day 0) and post-training (up to 4 weeks))
- Gross Motor Function Measure-88(At baseline (day 0) and post-training (up to 4 weeks))
- Motor Function Measure-20(At baseline (day 0) and post-training (up to 4 weeks))
- 10-Meter Walking Test (10MWT)(At baseline(day 0) and post-training (up to 4 weeks))
- 2-Minute Walking Test (2MWT)(At baseline(day 0) and post-training (up to 4 weeks))
- Modified Ashworth Scale (MAS)(At selection, baseline and post-training (up to 4 weeks))
- Pediatric Balance Score (PBS)(At baseline and post-training (up to 4 weeks))
- Location and level of pain - Face Pain Scale-Revised(From baseline to post-training (up to 4 weeks))
- OMNI Rating of Perceived Exertion(rom baseline to post-training (up to 4 weeks))
- Functional Independence Measure For Children (WeeFIM)(At baseline and post-training (up to 4 weeks))
- Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) score(At post-training (up to 4 weeks))
- Self-perceived impact on general health status(At post-training (up to 4 weeks))
- EuroQol 5 Dimensions Youth - 5 Levels (EQ-5D-Y-5L)(At baseline and post-training (up to 4 weeks))
- Lower extremity muscle strength(At baseline (day 0) and post-training (up to 4 weeks))
- 10-Meter Walk Test (10MWT)(At baseline (day 0) and post-training (up to 4 weeks))
- 2-Minute Walk Test (2MWT)(At baseline (day 0) and post-training (up to 4 weeks))
- Pediatric Balance Scale (PBS)(At baseline and post-training (up to 4 weeks))
- Location and level of pain - Faces Pain Scale-Revised(From baseline to post-training (up to 4 weeks))
- OMNI Rating of Perceived Exertion(From baseline to post-training (up to 4 weeks))
- Functional Independence Measure for Children (WeeFIM)(At baseline and post-training (up to 4 weeks))
- Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) score(At post-training (up to 4 weeks))