Cerebral Palsy (CP)NCT07146932
Evaluating the Bambini Teens Exoskeleton for Pediatric Cerebral Palsy
A study testing Pediatric Lower Limb Exoskeleton (Bambini Teens) in people with Cerebral Palsy (CP), run by COSMO ROBOTICS CO., Ltd at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Pediatric Lower Limb Exoskeleton (Bambini Teens)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Kessler Foundation
West Orange, New Jersey, 07052
Mohammed Huzien, 973-968-6631, mhuzien@kesslerfoundation.org
About this study
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?
Read more
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.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Pediatric Lower Limb Exoskeleton (Bambini Teens)
- Keywords
- Bambini Teens, Cerebral Palsy, Exoskeleton, ExoAtlet, Cosmo Robotics, Wearable Robotic Devices
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Bambini Teens Exoskeleton Gait Training | Experimental | 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. Receives: Device: Pediatric Lower Limb Exoskeleton (Bambini Teens) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of intervention (~3 weeks, at final assessment)
Secondary outcomes (10)
Physical Impairment - Blood Pressure
Change in resting systolic and diastolic blood pressure measured using a standard sphygmomanometer.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline to end of intervention (approximately 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study startOct 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- COSMO ROBOTICS CO., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kessler Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146932
- Sponsor's protocol ID
- EXO-CIP-002
- Status last verified
- Sep 2025
- First submitted
- 13 Aug 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Bambini Teens Exoskeleton for Pediatric Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07146932
- Acronym / sponsor ID
- EXO-CIP-002
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Bambini Teens, Cerebral Palsy, Exoskeleton, ExoAtlet, Cosmo Robotics, Wearable Robotic Devices
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- COSMO ROBOTICS CO., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Kessler Foundation
- Study start
- Oct 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bambini Teens Exoskeleton Gait Training | Experimental | Device: Pediatric Lower Limb Exoskeleton (Bambini Teens)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. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Bambini Teens Exoskeleton Gait Training |
Primary outcome
Device Safety
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
10 secondary outcomes
Physical Impairment - Blood Pressure
Time frame: Baseline to end of intervention (approximately 3 weeks)
Physical Impairment - Muscle Strength
Time frame: Baseline to end of intervention (approximately 3 weeks)
Physical Impairment - Joint Range of Motion
Time frame: Baseline to end of intervention (approximately 3 weeks)
Physical Impairment - Spasticity
Time frame: Baseline to end of intervention (approximately 3 weeks)
Endurance
Time frame: Baseline to end of intervention (approximately 3 weeks)
10-Meter Walk Test
Time frame: Baseline to end of intervention (approximately 3 weeks)
Timed Up and Go (TUG)
Time frame: Baseline to end of intervention (approximately 3 weeks)
Gait Mat Assessment
Time frame: Baseline to end of intervention (approximately 3 weeks)
Pediatric Balance Scale (PBS)
Time frame: Baseline to end of intervention (approximately 3 weeks)
Pediatric Quality of Life Inventory (PedsQL)
Time frame: Baseline to end of intervention (approximately 3 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric Lower Limb Exoskeleton (Bambini Teens) in people with Cerebral Palsy (CP), run by COSMO ROBOTICS CO., Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Huzien (973-968-6631, mhuzien@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Safety (time frame: Baseline to end of intervention (approximately 3 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.