Robotic Knee Orthosis-assisted Walking in CP

NCT ID: NCT06887764

Last Updated: 2026-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-10
• Study Completion Date: 2026-12-31

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 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.

Detailed Description

Robotic knee orthosis (RKO) can assist with voluntary knee extension and potentially reduce crouch/flexed-knee gait, but the efficacy of this technology in children with CP is unknown. This study aims to assess the effectiveness of Agilik as an assistive device for children with CP. Ten children with CP, ages 8 to 17 years, and at GMFCS level II, will be recruited for this pilot study. Each child will participate in a total of four visits over four weeks duration. The first three visits will also include RKO device fitting and tuning, followed by RKO-assisted walking practice to help with device acclamation. The walking practice will last up to 30 minutes. A two-minute walk test (2MWT) will be conducted at the first visit, which will serve as a reference to assess any shift in endurance from device-tuning/practice visits. The fourth and final visit will include 2MWT and 3D motion capture of shod and RKO-assisted conditions and may take up to 3 to 4 hours.

Conditions

Crouch Gait; Cerebral Palsy (CP)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

RKO-assisted walking in children with CP

Intervention Type: DEVICE

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.

Interventions

RKO-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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

David Scher, MD

Attending Orthopaedic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital for Special Surgery

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David M Scher, MD

Role: CONTACT

scherd@hss.edu

212 606-1253

Vishnu Deep Chandran, PhD

Role: CONTACT

chandranv@hss.edu

212-606-1215

Facility Contacts

David M Scher, MD

Role: primary

scherd@hss.edu

212 606-1253

Vishnu Deep Chandran, PhD

Role: backup

chandranv@hss.edu

212-606-1215

Other Identifiers

2023-2299

Identifier Type: -

Identifier Source: org_study_id