Robotic Knee Orthosis-assisted Walking in CP

Last updated: March 14, 2025
Sponsor: Hospital for Special Surgery, New York
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Palsy

Treatment

RKO-assisted walking in children with CP

Clinical Study ID

NCT06887764
2023-2299
  • Ages 8-17
  • 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 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.

Eligibility Criteria

Inclusion

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 hipsextended

  • 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

Exclusion Criteria:

  • Plantarflexion contracture, when measured in neutral foot alignment

  • 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) or botox intervention (within six months)

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: RKO-assisted walking in children with CP
Phase:
Study Start date:
February 10, 2025
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Hospital for Special Surgery

    New York, New York 10021
    United States

    Active - Recruiting

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