Robotic Knee Orthosis-assisted Walking in CP

NCT06887764 | Completed

• 1 other identifier: 2023-2299
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Robotic Knee Orthosis; Crouch Gait; Flexed-knee Gait; Cerebral Palsy

Outcome Measures

Primary Outcomes (7)

• Distance from 2MWT

  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

  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

  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

  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

  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

  "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

  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.

Study Arms (1)

Effect of a powered knee orthosis in individuals with Cerebral Palsy and Flexed-knee Gait

EXPERIMENTAL

Device: RKO-assisted walking in individuals with CP

Interventions

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.

Effect of a powered knee orthosis in individuals with Cerebral Palsy and Flexed-knee Gait

Eligibility Criteria

• Age: 8 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Orthopaedic Surgeon

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 20, 2025
• Study Start: February 10, 2025
• Primary Completion: April 25, 2026
• Study Completion: April 25, 2026
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within 12 months of the trial completion.
• 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.

Locations

US (1)