Robotic Knee Orthosis-assisted Walking in CP

Phase

N/A

Condition

Cerebral Palsy

Treatment

RKO-assisted walking in children with CP

RKO-assisted walking in individuals with CP

Clinical Study ID

NCT06887764

2023-2299

Ages 8-65
All Genders

Study Summary

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 individuals with neurological disorders. However, Agilik is relatively new, and its efficacy in individuals with CP is unknown. Therefore, this study aims to assess the effectiveness of Agilik as an assistive device for individuals with CP and crouch gait. In this pilot study, ten individuals with CP, GMFCS levels I and II, and crouch gait will walk with Agilik under the supervision of a physical therapist. Assessments of walking with shoes or AFO and Agilik will evaluate the efficacy of the device. The pilot study will assess if Agilik decreases crouch and improves gait characteristics in individuals with CP.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Diagnosed with cerebral palsy at GMFCS levels I and II
Exhibits crouch gait
Between 8 to 65 years of age
Hip flexion contracture less than 10 degrees
Knee flexion contracture less than 20 degrees when measured in prone with hipsextended
Thigh-foot angle is between 15 degrees (internal) to 30 degrees (external) in prone
Can walk a minimum distance of 10 meters without stopping

Exclusion

Exclusion Criteria:

No other neurological, musculoskeletal, or cardiorespiratory health conditions orinjuries
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 (withintwelve months)

Study Design

RKO-assisted walking in children with CP

February 10, 2025

April 25, 2026

Study Description

Robotic knee orthosis (RKO) can assist with voluntary knee extension and potentially reduce crouch/flexed-knee gait, but the effectiveness of this technology in individuals with CP is unknown. This study aims to assess the efficacy of Agilik as an assistive device for individuals with CP. Ten individuals with CP, ages 8 to 65 years, and at GMFCS levels I and II, will be recruited for this pilot study. Each individual will participate in a maximum of four sessions/ visits. The first three sessions will include RKO device fitting and tuning, followed by RKO-assisted walking practice to help with device acclimation. These sessions will last up to 60 minutes. A two-minute walk test (2MWT) will also be conducted at the first visit, which will serve as a reference to assess any shift in endurance from device-tuning/ practice. The final visit will include 2MWT and 3D motion capture in shod (shoes or shoes+AFO) and RKO-assisted (shoes+RKO or shoes+AFO+RKO) conditions, and may take up to 3 to 4 hours.

Connect with a study center

Hospital for Special Surgery
New York, New York 10021
United States
Site Not Available

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