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| Name | Class |
|---|---|
| Kessler Foundation | OTHER |
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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:
Researchers will compare participants' mobility measured at baseline to their mobility after the intervention to see if improvements occur.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | End of intervention (~3 weeks, at final assessment) |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Impairment - Blood Pressure | Change in resting systolic and diastolic blood pressure measured using a standard sphygmomanometer. | Baseline to end of intervention (approximately 3 weeks) |
| Physical Impairment - Muscle Strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammed Huzien | Contact | 973-968-6631 | mhuzien@kesslerfoundation.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Foundation | West Orange | New Jersey | 07052 | United States |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Change in muscle strength of upper and lower limbs measured using the Manual Muscle Testing (MMT) scale (0-5 grades).
| 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. | 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). | 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. | 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 | 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. | 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). | 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. | 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. | Baseline to end of intervention (approximately 3 weeks) |