Robotic Knee Orthosis-assisted Walking in CP

June 16, 2026 updated by: David Scher, MD, Hospital for Special Surgery, New York

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 hips extended
  • 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 Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Effect of a powered knee orthosis in individuals with Cerebral Palsy and Flexed-knee Gait
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distance from 2MWT
Time Frame: From enrollment until data collection is performed on the fourth study session.
The distance covered by participants during a two-minute walking test (2MWT) will be compared between RKO-assisted and shod conditions.
From enrollment until data collection is performed on the fourth study session.
Step length
Time Frame: At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.
Mean step length (distance between the two feet measured from the heel of one foot to the heel of the contralateral foot while both feet are on the ground) during walking will be compared between RKO-assisted and shod conditions.
At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.
Single limb support time
Time Frame: At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.
Mean single limb support time (duration just one foot by itself is on the ground) during walking will be compared between RKO-assisted and shod conditions.
At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.
Walking speed
Time Frame: At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.
Mean walking speed during walking will be compared between RKO-assisted and shod conditions.
At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.
Lower limb joint kinematics
Time Frame: At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.
The sagittal plane lower limb joint angles (degrees) during walking will be compared to evaluate the difference between RKO-assisted and shod conditions.
At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.
Binary indicator of improvement in walking distance with RKO use
Time Frame: At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.
"Yes" if the walking distance in the RKO-assisted condition was greater than shod, and "No" if there was no improvement.
At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.
Lower limb electromyography data
Time Frame: At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.
Electromyography (EMG) amplitude and duration of lower limb anti-gravity muscles (rectus femoris, vastus lateralis, vastus medialis, medial gastrocnemius, soleus, and gluteus maximus) will be compared between RKO-assisted and shod conditions. The EMG data will be filtered and rectified to compute linear envelopes. From these envelopes, the average value of EMG amplitude and duration will be compared between RKO-assisted and shod conditions.
At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2025

Primary Completion (Actual)

April 25, 2026

Study Completion (Actual)

April 25, 2026

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 14, 2025

First Posted (Actual)

March 20, 2025

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-2299

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study results (de-identified) will be disseminated in conference abstracts and peer-reviewed journal articles.

IPD Sharing Time Frame

Within 12 months of the trial completion.

IPD Sharing Access Criteria

Data and supporting information will be shared upon reasonable request to the PI. After the PI reviews and approves the applicant's request, de-identified information will be provided.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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