CompletedNot Applicable

Robotic Knee Orthosis-assisted Walking in CP

United States10 participantsStarted 2025-02-10

Plain-language 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.

Who can participate

Age range

8 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial used a robotic knee orthosis to help children with cerebral palsy who have crouch gait walk better — is a robotic knee orthosis something worth considering for my child's specific type of crouch gait, and are there centers near us that offer this kind of device?
2The trial measured things like walking speed, step length, and how long the child could stand on one leg — based on my child's current walking ability, would their results on those same measures suggest they might benefit from this type of assistive technology?
3Since this trial is already completed, has your practice seen the results, and do they change how you think about recommending robotic orthotics compared to more traditional bracing or physical therapy for crouch gait in CP?
4The trial also recorded muscle activity through electromyography — would it be useful to do that kind of muscle testing on my child to better understand what's driving their crouch gait before deciding on any treatment?
5Because this was a non-randomized feasibility study rather than a large controlled trial, how confident can we be in what the results actually tell us about safety and benefit, and what would need to be true before you'd feel comfortable recommending a robotic knee orthosis as part of my child's care plan?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Distance from 2MWT

Timeframe: From enrollment until data collection is performed on the fourth study session.

Step length

Timeframe: 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

Timeframe: At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.

Walking speed

Timeframe: 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

Timeframe: 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

Timeframe: At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.

Trial details

NCT IDNCT06887764

SponsorHospital for Special Surgery, New York

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-25

View on ClinicalTrials.gov More Crouch Gait trials

Plain-language summary

Who can participate

Age range

8 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Distance from 2MWT

Timeframe: From enrollment until data collection is performed on the fourth study session.

Step length

Timeframe: 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

Timeframe: At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.

Walking speed

Timeframe: 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

Timeframe: 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

Timeframe: At the end of the study visit for each participant, data collection will be performed during the fourth study session from enrollment.