Evaluating the Bambini Teens Exoskeleton for Pediatric Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Device Safety
研究概览
简要总结
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.
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
- 5 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
研究组 & 干预措施
Bambini Teens Exoskeleton Gait Training
Participants in this arm will receive gait training using the Bambini Teens Exoskeleton. Each participant will complete six training sessions, each lasting 30 minutes, conducted 2-3 times per week over approximately 3 weeks.
干预措施: Pediatric Lower Limb Exoskeleton (Bambini Teens) (Device)
结局指标
主要结局
Device Safety
时间窗: Baseline to end of intervention (approximately 3 weeks)
Incidence of device-related serious adverse events (SAEs) and other adverse events (AEs) occurring during the intervention period, recorded in an adverse event log.
Participant Usage and Treatment Compliance
时间窗: Baseline to end of intervention (approximately 3 weeks)
Proportion of participants who complete all six planned gait training sessions under the supervision of a licensed physical therapist. Completion will be verified by session attendance and completion records.
Feasibility of Usage
时间窗: Baseline to end of intervention (approximately 3 weeks)
Proportion of participants for whom the treating physical therapist successfully fits the device and records session-specific device settings, as documented in the session logs.
Clinician Treatment Satisfaction
时间窗: End of intervention (~3 weeks, at final assessment)
Clinician satisfaction with the intervention, measured using a standardized FORM questionnaire completed by the treating physical therapist at the end of the intervention.
次要结局
- Physical Impairment - Blood Pressure(Baseline to end of intervention (approximately 3 weeks))
- Physical Impairment - Muscle Strength(Baseline to end of intervention (approximately 3 weeks))
- Physical Impairment - Joint Range of Motion(Baseline to end of intervention (approximately 3 weeks))
- Physical Impairment - Spasticity(Baseline to end of intervention (approximately 3 weeks))
- Endurance(Baseline to end of intervention (approximately 3 weeks))
- 10-Meter Walk Test(Baseline to end of intervention (approximately 3 weeks))
- Timed Up and Go (TUG)(Baseline to end of intervention (approximately 3 weeks))
- Gait Mat Assessment(Baseline to end of intervention (approximately 3 weeks))
- Pediatric Balance Scale (PBS)(Baseline to end of intervention (approximately 3 weeks))
- Pediatric Quality of Life Inventory (PedsQL)(Baseline to end of intervention (approximately 3 weeks))