Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство ABLE Kids
  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.

Первичные конечные точки

• Number and type of device-related Adverse Events [Срок оценки: From baseline to follow-up (up to 2 weeks after end of intervention)]
• Time taken to don/doff the device [Срок оценки: Up to 3 weeks]
• Number of steps walked [Срок оценки: Up to 6 weeks]
• Distance walked [Срок оценки: Up to 6 weeks]
• Time spent upright and time spent walking [Срок оценки: Up to 6 weeks]
• Number of people assisting the session [Срок оценки: Up to 6 weeks]

Вторичные конечные точки (12)

• Lower extremity muscle strenght [Срок оценки: At baseline (day 0) and post-training (up to 4 weeks)]
• Gross Motor Function Measure-88 [Срок оценки: At baseline (day 0) and post-training (up to 4 weeks)]
• Motor Function Measure-20 [Срок оценки: At baseline (day 0) and post-training (up to 4 weeks)]
• 10-Meter Walking Test (10MWT) [Срок оценки: At baseline(day 0) and post-training (up to 4 weeks)]
• 2-Minute Walking Test (2MWT) [Срок оценки: At baseline(day 0) and post-training (up to 4 weeks)]
• Modified Ashworth Scale (MAS) [Срок оценки: At selection, baseline and post-training (up to 4 weeks)]
• Pediatric Balance Score (PBS) [Срок оценки: At baseline and post-training (up to 4 weeks)]
• Location and level of pain - Face Pain Scale-Revised [Срок оценки: From baseline to post-training (up to 4 weeks)]
• OMNI Rating of Perceived Exertion [Срок оценки: rom baseline to post-training (up to 4 weeks)]
• Functional Independence Measure For Children (WeeFIM) [Срок оценки: At baseline and post-training (up to 4 weeks)]
• Self-perceived impact on general health status [Срок оценки: At post-training (up to 4 weeks)]
• Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) score [Срок оценки: At post-training (up to 4 weeks)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Severe spasticity in the lower limbs (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 (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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Som·hi Rehab — Girona

Идентификаторы

NCT: NCT07745712 · ABLEkidsSP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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