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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Kessler Foundation
West Orange, New Jersey, United States
Device Safety
Incidence of device-related serious adverse events (SAEs) and other adverse events (AEs) occurring during the intervention period, recorded in an adverse event log.
Time frame: Baseline to end of intervention (approximately 3 weeks)
Participant Usage and Treatment Compliance
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.
Time frame: Baseline to end of intervention (approximately 3 weeks)
Feasibility of Usage
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.
Time frame: Baseline to end of intervention (approximately 3 weeks)
Clinician Treatment Satisfaction
Clinician satisfaction with the intervention, measured using a standardized FORM questionnaire completed by the treating physical therapist at the end of the intervention.
Time frame: End of intervention (~3 weeks, at final assessment)
Physical Impairment - Blood Pressure
Change in resting systolic and diastolic blood pressure measured using a standard sphygmomanometer.
Time frame: Baseline to end of intervention (approximately 3 weeks)
Physical Impairment - Muscle Strength
Change in muscle strength of upper and lower limbs measured using the Manual Muscle Testing (MMT) scale (0-5 grades).
Time frame: Baseline to end of intervention (approximately 3 weeks)
Physical Impairment - Joint Range of Motion
Change in the range of motion of upper and lower limb joints measured using a goniometer, reported as change in degrees.
Time frame: Baseline to end of intervention (approximately 3 weeks)
Physical Impairment - Spasticity
Change in spasticity of lower extremities measured using the Modified Ashworth Scale (0-4 scores, with higher scores indicating greater spasticity).
Time frame: Baseline to end of intervention (approximately 3 weeks)
Endurance
Distance walked in meters during the 6-Minute Walk Test (6MWT), used as a submaximal test of aerobic capacity/endurance and a functional assessment of walking efficiency.
Time frame: Baseline to end of intervention (approximately 3 weeks)
10-Meter Walk Test
A functional ambulation assessment of walking speed over a 10-meter distance, reported in meters per second (m/s). Higher values indicate faster walking ability
Time frame: Baseline to end of intervention (approximately 3 weeks)
Timed Up and Go (TUG)
Assessment of functional mobility and balance, measuring the time (in seconds) required for a participant to stand up from a chair, walk 3 meters, turn, return, and sit down. Shorter times indicate better mobility.
Time frame: Baseline to end of intervention (approximately 3 weeks)
Gait Mat Assessment
Temporal and spatial gait parameters obtained from an instrumented walkway provide quantitative information about walking and standing balance. Values are reported in standard gait units (e.g., step length in cm, velocity in m/s).
Time frame: Baseline to end of intervention (approximately 3 weeks)
Pediatric Balance Scale (PBS)
A 14-item scale assessing functional balance in children, with scores ranging from 0 to 56. Higher scores indicate better balance.
Time frame: Baseline to end of intervention (approximately 3 weeks)
Pediatric Quality of Life Inventory (PedsQL)
Change in health-related quality of life assessed by the Pediatric Quality of Life Inventory (PedsQL). The PedsQL total score ranges from 0 to 100, with higher scores indicating better quality of life.
Time frame: Baseline to end of intervention (approximately 3 weeks)
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