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Robotic Knee Orthosis-assisted Walking in CP

NCT06887764 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-06-18

No results posted yet for this 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.

Conditions

  • Crouch Gait
  • Cerebral Palsy (CP)

Interventions

DEVICE

RKO-assisted walking in individuals with CP

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

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-10
Primary Completion
2026-04-25
Completion
2026-04-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06887764 on ClinicalTrials.gov