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

Trial Summary

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 data supports the effectiveness of the treatment Robotic Knee Orthosis (RKO) for Cerebral Palsy?

While the research does not directly address the effectiveness of Robotic Knee Orthosis for Cerebral Palsy, studies on robotic-assisted knee surgeries show that robotic technology can improve precision and alignment in knee procedures. This suggests that similar robotic assistance might help improve movement and alignment in conditions like Cerebral Palsy. ^{1 2 3 4 5}

How is the Robotic Knee Orthosis treatment different from other treatments for cerebral palsy?

The Robotic Knee Orthosis (RKO) is unique because it likely incorporates robotic technology to assist knee movement, which may offer more dynamic support compared to traditional braces like ankle-foot orthoses (AFOs) or knee-ankle-foot orthoses (KAFOs) that are commonly used for cerebral palsy. This could potentially improve mobility and function by providing more precise and adaptable assistance to the knee joint. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the first semi-active total knee arthroplasty assisting robot made in China: a retrospective propensity score-matched cohort study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

MAKO Robotic-Arm Assisted Total Knee Arthroplasty: Surgical Technique From the Office to the Operating Room. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Robot-assisted surgery in total knee arthroplasty: trauma maker or trauma savior? A prospective, randomized cohort study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Robotic-Assisted Total Knee Arthroplasty Can Increase Frequency of Achieving Target Limb Alignment in Primary Total Knee Arthroplasty for Preoperative Valgus Deformity. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Minimal Clinically Important Difference in Robotic-Assisted Total Knee Arthroplasty Versus Standard Manual Total Knee Arthroplasty. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Dynamic bracing: elastics for patients with cerebral palsy, muscular dystrophy and myelodysplasia. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Ankle-foot orthoses in children with cerebral palsy: a cross sectional population based study of 2200 children. [2021]

8. England 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. [2018]

9. France pubmed.ncbi.nlm.nih.gov

Effect of floor reaction ankle-foot orthosis on crouch gait in patients with cerebral palsy: What can be expected? [2022]

10. England pubmed.ncbi.nlm.nih.gov

The reciprocation-gait orthosis for children with myelodysplasia. [2005]