Robotic Knee Orthosis-assisted Walking in CP

Hospital for Special Surgery (HSS)

Status

Enrolling

Conditions

Cerebral Palsy (CP)

Crouch Gait

Treatments

Device: RKO-assisted walking in children with CP

Study type

Interventional

Funder types

Other

Identifiers

NCT06887764

2023-2299

Details and patient eligibility

About

Robotic exoskeletons are becoming increasingly accepted to provide upright mobility in individuals with neurological disorders. These devices can assist in overcoming gravitational forces and reduce energy consumption. Agilik is one such device intended for children with neurological disorders. However, Agilik is relatively new, and its efficacy in children with CP is unknown. Therefore, this study aims to assess the effectiveness of Agilik as an assistive device for children with CP and crouch gait. In this pilot study, ten children with CP, GMFCS level II, and crouch gait will walk with Agilik under the supervision of a physical therapist. Assessments of walking with AFO and Agilik will evaluate the efficacy of the device. The pilot study will assess if Agilik decreases crouch and improves gait characteristics in children with CP.

Full description

Robotic knee orthosis (RKO) can assist with voluntary knee extension and potentially reduce crouch/flexed-knee gait, but the efficacy of this technology in children with CP is unknown. This study aims to assess the effectiveness of Agilik as an assistive device for children with CP. Ten children with CP, ages 8 to 17 years, and at GMFCS level II, will be recruited for this pilot study. Each child will participate in a total of four visits over four weeks duration. The first three visits will also include RKO device fitting and tuning, followed by RKO-assisted walking practice to help with device acclamation. The walking practice will last up to 30 minutes. A two-minute walk test (2MWT) will be conducted at the first visit, which will serve as a reference to assess any shift in endurance from device-tuning/practice visits. The fourth and final visit will include 2MWT and 3D motion capture of shod and RKO-assisted conditions and may take up to 3 to 4 hours.

Enrollment

10 estimated patients

Sex

All

Ages

8 to 17 years old

Volunteers

No Healthy Volunteers

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)