Robotic Knee Orthosis for Cerebral Palsy

Overseen By Vishnu Deep Chandran, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Hospital for Special Surgery, New York

Disqualifiers: Plantarflexion contracture, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a robotic device called Agilik to assist children with cerebral palsy (CP) who walk with a crouched posture. The aim is to determine if Agilik can ease walking and enhance movement in these children. The trial seeks children diagnosed with CP who can walk at least 10 meters without stopping and exhibit a crouch gait. Participants will collaborate with a physical therapist to compare Agilik, a robotic knee orthosis (RKO), with their usual walking aids. As an unphased trial, this study provides a unique opportunity for children to potentially improve their mobility with innovative technology.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this robotic knee orthosis is safe for children with cerebral palsy?

Research shows that robotic knee braces (RKOs) are generally well-tolerated by individuals with neurological disorders. Studies have found that RKOs, such as AiWalker-K, can be safely used in children with cerebral palsy (CP) under medical supervision. Notably, a study on robot-assisted walking training, similar to using an RKO, reported no negative effects among participants. This suggests that RKOs might be safe. However, Agilik, the specific device under study, is relatively new. While early results are promising, participants should remember that the device's safety is still under evaluation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Robotic Knee Orthosis (RKO) is unique because it provides a powered assist to knee movement, specifically designed for individuals with cerebral palsy who have a flexed-knee gait. Unlike traditional physical therapy and orthopedic surgeries, which can be invasive or require long-term commitment, the RKO offers a non-invasive, technology-driven approach that can be tailored to each individual's needs. Researchers are excited about this treatment because it has the potential to improve mobility and quality of life by directly supporting and enhancing the natural movement of the knee, potentially leading to more effective and quicker improvements in gait compared to standard treatments.

What evidence suggests that the Robotic Knee Orthosis is effective for children with cerebral palsy?

This trial will evaluate the effectiveness of the Robotic Knee Orthosis (RKO) in individuals with cerebral palsy and flexed-knee gait. Studies have shown that robotic knee braces, such as Agilik, can assist in straightening the knee, potentially reducing bent-knee walking. This is particularly beneficial for children with cerebral palsy who struggle to walk upright. Research indicates that up to 18% of studies have identified a reduction in bent-knee walking as a significant outcome for individuals with cerebral palsy. Additionally, using these robotic braces has improved walking in other conditions, such as post-stroke recovery. Although specific data on Agilik's effectiveness for children with cerebral palsy is limited, early indications suggest it may enhance walking. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for children with Cerebral Palsy (CP) who have a specific walking pattern known as crouch gait. They should be able to walk at least a little bit, which means they are GMFCS level II. The study doesn't list exclusion criteria, but typically those would include factors that make it unsafe or impractical for someone to participate.

Inclusion Criteria

I have cerebral palsy and can walk without assistance.

Thigh-foot angle is between 10 degrees (internal) to 25 degrees (external) in prone

My knee can bend almost fully.

Exclusion Criteria

I can understand instructions and communicate if I'm in pain.

I do not have any neurological, musculoskeletal, or heart/lung conditions.

My foot cannot fully straighten due to tightness.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Device Fitting and Tuning

RKO device fitting and tuning, followed by RKO-assisted walking practice

3 weeks

3 visits (in-person)

Assessment

Final assessment including 2MWT and 3D motion capture of shod and RKO-assisted conditions

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Robotic Knee Orthosis (RKO)

Trial Overview The trial is testing the effectiveness of a robotic knee orthosis called Agilik in assisting children with CP during walking. It's a pilot study involving ten kids who will use the device under physical therapist supervision to see if it helps reduce their crouch and improve how they walk.

How Is the Trial Designed?

Group I: Effect of a powered knee orthosis in individuals with Cerebral Palsy and Flexed-knee Gait Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Published Research Related to This Trial

The study involving nine adults with poliomyelitis showed that using heel-to-toe rocker-soled footwear with knee-ankle-foot orthoses (KAFOs) significantly increased maximum hip joint extension and stride length, suggesting improved gait mechanics.

While the rocker sole adaptation did not significantly increase walking speed or cadence, it reduced hip abduction and adduction, indicating potential benefits for ambulation in patients using KAFOs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of footwear adapted with a multi-curved rocker sole in conjunction with knee-ankle-foot orthoses on walking in poliomyelitis subjects: a pilot study. Mojaver, A., Arazpour, M., Aminian, G., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06887764

Robotic Knee Orthosis-assisted Walking in CP Robotic knee orthosis (RKO) can assist with voluntary knee extension and potentially reduce crouch/flexed-knee gait, but the efficacy of this technology in ...

2. withpower.com withpower.com/trial/phase-crouch-gait-1-2025-90279

Robotic Knee Orthosis for Cerebral Palsy 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 ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06887764/robotic-knee-orthosis-assisted-walking-in-cp

Robotic Knee Orthosis-assisted Walking in CP Robotic knee orthosis (RKO) can assist with voluntary knee extension and potentially reduce crouch/flexed-knee gait, but the efficacy of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12458414/

A Systematic Review of Robotic Exoskeletons for Cerebral Palsy Reduction in crouch gait, reported in 18% of studies, is a key outcome for individuals with CP, following knee extension in frequency. Other outcomes ...

5. journals.sagepub.com journals.sagepub.com/doi/pdf/10.3233/BME-151326

Reduced knee hyperextension after wearing a robotic ... This orthosis has been used for gait training in hemiparesis after stroke and results demonstrated improvement in gait capability [12, 13]. The benefitting ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11111022/

Clinical study on the safety and feasibility of AiWalker-K for ... Under the guidance of experienced medical personnel, AiWalker-K can be used for rehabilitation in children with CP.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9918396/

Safety and Feasibility of Robot-assisted Gait Training in Adults ... Results: All subjects completed the study. No adverse events were noted. Walking speed in the 10MWT test increased from 32.5 s (± 24.5 s) at T1 ...