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Completed

NCT Number: NCT06887764

Robotic Knee Orthosis-assisted Walking in CP

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.

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Key information

Conditions

Crouch Gait Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Cerebral Palsy (CP) Nervous System Diseases

Age range

8 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

RKO-assisted walking in individuals with CP

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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