Using a robotic knee device to help children with cerebral palsy walk better
A Pilot Study to Examine the Effect of a Powered Knee Orthosis on Crouch Gait in Cerebral Palsy
This study is testing if a robotic knee device can help children with cerebral palsy walk better and reduce crouch gait.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 8 Years to 17 Years |
| Sex | All |
| Sponsor | Hospital for Special Surgery, New York Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06887764 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effectiveness of the Agilik robotic knee orthosis in assisting children with cerebral palsy (CP) who exhibit crouch gait. Ten children aged 8 to 17 years, classified as GMFCS level II, will participate in four visits over four weeks, where they will undergo device fitting, tuning, and practice walking with the robotic device under the supervision of a physical therapist. The study will assess changes in walking endurance and gait characteristics through a two-minute walk test and 3D motion capture analysis. The goal is to determine if the Agilik device can reduce crouch gait and improve overall walking ability in these children.
Who should consider this trial
Good fit: Ideal candidates are children aged 8 to 17 years with cerebral palsy at GMFCS level II who exhibit crouch gait.
Not a fit: Patients with significant contractures, other neurological or musculoskeletal conditions, or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance mobility and quality of life for children with cerebral palsy by providing a new assistive walking device.
How similar studies have performed: While robotic exoskeletons have shown promise in other neurological conditions, the specific application of Agilik in children with CP is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with cerebral palsy at GMFCS level II * Exhibits crouch gait * Between 8 to 17 years of age * Hip flexion contracture less than 5 degrees * Knee flexion contracture less than 20 degrees when measured in prone with hips extended * Thigh-foot angle is between 10 degrees (internal) to 25 degrees (external) in prone * Can walk a minimum distance of 10 meters without stopping Exclusion Criteria: * Plantarflexion contracture, when measured in neutral foot alignment * No other neurological, musculoskeletal, or cardiorespiratory health conditions or injuries * The presence of any cognitive impairment that could limit the ability to understand, follow simple directions, and inform when in pain * Inability to participate in the study because of recent orthopedic surgery (within twelve months) or botox intervention (within six months)
Where this trial is running
New York, New York
- Hospital for Special Surgery — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: David M Scher, MD
- Email: scherd@hss.edu
- Phone: 212 606-1253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.