Health TrialsbyHealthPanel

Evaluating the Bambini Teens Exoskeleton for Pediatric Cerebral Palsy

ConditionCerebral Palsy (CP)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-14
SponsorCOSMO ROBOTICS CO., Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Pediatric Lower Limb Exoskeleton (Bambini Teens)

    Device

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Bambini Teens Exoskeleton Gait TrainingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)
2

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)
3

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)
4

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

COSMO ROBOTICS CO., Ltd

Lead sponsor

Kessler Foundation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: