Evaluating the Bambini Teens Exoskeleton for Pediatric Cerebral Palsy

Обзор

The goal of this clinical trial is to evaluate the safety and effectiveness of the Bambini Teens exoskeleton as a gait training tool in children aged 5 to 14 years diagnosed with cerebral palsy (CP). The main questions it aims to answer are: * Is the Bambini Teens exoskeleton device safe and feasible as a gait training intervention for children with cerebral palsy, without resulting in a significant incidence of device-related serious adverse events? * Is it feasible for physical therapists to use the Bambini Teens exoskeleton as a gait training intervention for children with cerebral palsy, meaning participants will successfully complete the training sessions? * Will participants' mobility, specifically their self-selected walking speed, improve after receiving gait training using the Bambini Teens exoskeleton compared to baseline measurements? Researchers will compare participants' mobility measured at baseline to their mobility after the intervention to see if improvements occur. Participants will: * Complete 6 gait training sessions using the Bambini Pediatric Exoskeleton, monitored by a licensed physical therapist. * Each training session will be 30 minutes long, conducted 2-3 times per week for approximately 3 weeks. * Undergo evaluations at baseline and post-intervention (after approximately 3 weeks), with each evaluation session lasting approximately 2 hours. * May also participate in optional motor evaluations.

Вмешательства

• Устройство Pediatric Lower Limb Exoskeleton (Bambini Teens)
  The Bambini Teens Exoskeleton is a wearable robotic device developed to assist lower limb movement and facilitate gait training for pediatric patients with mobility impairments such as cerebral palsy. The device provides powered assistance at the hip, knee, and ankle joints, supports adjustable gait parameters, and is designed for use in clinical rehabilitation settings under professional supervision.

Первичные конечные точки

• Device Safety [Срок оценки: Baseline to end of intervention (approximately 3 weeks)]
• Participant Usage and Treatment Compliance [Срок оценки: Baseline to end of intervention (approximately 3 weeks)]
• Feasibility of Usage [Срок оценки: Baseline to end of intervention (approximately 3 weeks)]
• Clinician Treatment Satisfaction [Срок оценки: End of intervention (~3 weeks, at final assessment)]

Вторичные конечные точки (10)

• Physical Impairment - Blood Pressure [Срок оценки: Baseline to end of intervention (approximately 3 weeks)]
• Physical Impairment - Muscle Strength [Срок оценки: Baseline to end of intervention (approximately 3 weeks)]
• Physical Impairment - Joint Range of Motion [Срок оценки: Baseline to end of intervention (approximately 3 weeks)]
• Physical Impairment - Spasticity [Срок оценки: Baseline to end of intervention (approximately 3 weeks)]
• Endurance [Срок оценки: Baseline to end of intervention (approximately 3 weeks)]
• 10-Meter Walk Test [Срок оценки: Baseline to end of intervention (approximately 3 weeks)]
• Timed Up and Go (TUG) [Срок оценки: Baseline to end of intervention (approximately 3 weeks)]
• Gait Mat Assessment [Срок оценки: Baseline to end of intervention (approximately 3 weeks)]
• Pediatric Balance Scale (PBS) [Срок оценки: Baseline to end of intervention (approximately 3 weeks)]
• Pediatric Quality of Life Inventory (PedsQL) [Срок оценки: Baseline to end of intervention (approximately 3 weeks)]

Критерии участия

Критерии включения

• Between the age of 5 and 14 years and diagnosed with cerebral palsy;
• have joint range of motion within normal functional limits for ambulation as determined by study staff;
• Be able and willing to comply with study procedures, including follow-up requirements;
• Patient cognitive status and ability to communicate must be at a level consistent with that required to participate in standard motor rehabilitation;
• can follow directions as determined by study staff;
• be able to physically fit into exoskeleton device; height from 110 to 160 cm (43 to 62 inches) and weighing up less than 65 kg (145 lbs);
• be able to walk 10 meters with the aid of a walking assistive device and/or a single human assistant;
• bilateral lower limb spasticity that allows lower limb range of motion within the device.

Критерии исключения

• any medical issue that precludes full weight-bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity);
• skin issues that would prevent wearing the device;
• pre-existing condition that caused exercise intolerance;
• uncontrolled seizure disorder, spasticity or joint contracture that would interfere with walking;
• neuromuscular, neurological, cardiovascular or orthopedic pathologies that will interfere with neuromuscular function, ambulation, or limit the range of motion of the lower limbs;
• severe spasticity (Modified Ashworth Scale = or > 3);
• hip extension range of motion < 0 degrees, knee flexion contracture > 20 degrees, knee valgus > 40 degrees, 2 or more fractures within the past year, hip subluxation (> 40% migration),
• existing Baclofen pump, and/or Botox injections within the past 4 months of study enrollment;

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

США · 1 центр

• Kessler Foundation — West Orange

Идентификаторы

NCT: NCT07146932 · EXO-CIP-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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