RecruitingNot ApplicableNCT06887764

Robotic Knee Orthosis-assisted Walking in CP

A Pilot Study to Examine the Effect of a Powered Knee Orthosis on Crouch Gait in Cerebral Palsy


Sponsor

Hospital for Special Surgery, New York

Enrollment

10 participants

Start Date

Feb 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 8 YearsMax Age: 17 Years

Inclusion Criteria7

  • 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 Criteria4

  • 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)

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Interventions

DEVICERKO-assisted walking in children with CP

The investigators will assess walking in each of the following conditions: shod (shoes or shoes + AFO) and RKO-assisted (shoes + RKO), to achieve the following: (1) Evaluate the effect of RKO, compared to shod upon endurance in children with CP at GMFCS level II, and (2) Evaluate the effect of RKO, compared to shod, upon temporal-spatial parameters, lower limb sagittal joint kinematics, and muscle EMG in children with CP at GMFCS level II.


Locations(1)

Hospital for Special Surgery

New York, New York, United States

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NCT06887764


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