Pediatric Knee Exoskeleton for Knee Hyperextension

Overseen By Kinsey Herrin, MSPO

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Georgia Institute of Technology

Must not be taking: Botox

Disqualifiers: Uncontrolled seizures, Non-English speaking, others

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

Compensation: Varies

Number of Visits: 5

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment using a special knee exoskeleton designed to help children and young adults improve their walking. It targets individuals with excessive backward knee bending (genu recurvatum) or a crouched walking posture. Participants will use the device alongside a visual game to aid their therapy over five sessions. Ideal candidates can walk for six minutes without stopping and are willing to try the exoskeleton for five sessions, each lasting up to two hours. As an unphased trial, this study offers a unique opportunity to contribute to innovative research and potentially benefit from advanced therapy.

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

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

What prior data suggests that this exoskeleton is safe for pediatric patients?

Research shows that the pediatric knee exoskeleton is generally safe for children. Studies have found that kids with cerebral palsy, a condition affecting movement and muscle tone, tolerate this device well, and it helps them walk better without causing harm. In earlier trials, children used the exoskeleton while walking, and no major safety issues emerged. The exoskeleton effectively reduced problems like crouch gait, where the knees bend excessively while walking. Overall, evidence suggests that children can safely use this exoskeleton during therapy sessions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Pediatric Knee Exoskeleton is unique because it combines wearable technology with a visual biofeedback game to address knee hyperextension in children. Unlike traditional physical therapy exercises, this exoskeleton offers real-time feedback and support, potentially making rehabilitation more engaging and effective. Researchers are excited about this approach because it not only aids in correcting movement patterns but also encourages active participation from young patients, which could lead to quicker and more sustainable improvements in knee function.

What evidence suggests that this exoskeleton is effective for knee hyperextension?

Research has shown that the Pediatric Knee Exoskeleton, used by participants in this trial, can assist children with knee issues, such as backward-bending knees or walking difficulties, in improving their movement. One study found that the exoskeleton improved muscle activity and posture in most children. Another study demonstrated that it helped children extend their hips more while walking. These improvements suggest the device can enhance walking ability in children with mobility challenges. Additionally, the exoskeleton supports the knee joint, potentially making walking easier and more stable for children. ^{1 2 4 6 7}

Who Is on the Research Team?

Kinsey Herrin, MSPO

Principal Investigator

Georgia Institute of Technology

Are You a Good Fit for This Trial?

This trial is for children with knee hyperextension or crouch gait who are enrolled in the CHOA's Day Rehab Program. Specific eligibility details aren't provided, but typically participants must meet certain health criteria to be included.

Inclusion Criteria

I walk with my knees bending backward or in a crouched position.

I can walk nonstop for at least 6 minutes.

I am between 4 and 21 years old.

Exclusion Criteria

I cannot follow instructions from research staff.

I have not received a Botox injection during the study.

Non-English speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo 5 sessions of experimental therapeutic rehabilitation with the exoskeleton and visual biofeedback game

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pediatric Knee Exoskeleton

Trial Overview

The study tests a pediatric knee exoskeleton combined with visual biofeedback across five rehab sessions. It aims to see if this technology helps kids walk better by addressing their specific gait issues.

How Is the Trial Designed?

Group I: Pediatric Knee Exoskeleton Experimental Treatment 1 Intervention

N=5 patient participants will undergo 5 sessions of experimental therapeutic rehabilitation sessions with the exoskeleton and the visual biofeedback game. Participants will use the device for a maximum of 2 hours per session for 5 sessions.

Who Is Running the Clinical Trial?

Georgia Institute of Technology

Lead Sponsor

Trials

53

Recruited

5,600+

Children's Healthcare of Atlanta

Collaborator

Trials

172

Recruited

108,000+

Published Research Related to This Trial

A wearable exoskeleton was found to be safe and well-tolerated by ambulatory children with cerebral palsy (CP), effectively reducing crouch gait during walking, which is a common and debilitating issue in CP.

The exoskeleton improved knee extensor muscle activity and showed postural improvements in six out of seven participants, with benefits increasing over the course of a multiweek trial, suggesting its potential as a long-term treatment strategy for enhancing mobility in children with CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A lower-extremity exoskeleton improves knee extension in children with crouch gait from cerebral palsy. Lerner, ZF., Damiano, DL., Bulea, TC.[2023]

A powered exoskeleton designed for knee extension assistance showed promising results in improving knee extension by 18.1° and total knee range of motion by 21.0° in a six-year-old boy with cerebral palsy and crouch gait.

The device did not significantly reduce knee extensor muscle activity, suggesting that the child was able to use his muscles effectively while benefiting from the exoskeleton, indicating its potential for long-term gait training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Robotic Exoskeleton for Treatment of Crouch Gait in Children With Cerebral Palsy: Design and Initial Application. Lerner, ZF., Damiano, DL., Park, HS., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8249803/

A Pediatric Knee Exoskeleton With Real-Time Adaptive ...

Robotic trainers have shown some effectiveness in CP (Dodd and Foley, 2007) but results from controlled clinical trials indicate that device assisted approaches ...

2.

nature.com

nature.com/articles/s41598-017-13554-2

The Effects of Exoskeleton Assisted Knee Extension on ...

Knee extensor muscle activity decreased slightly during exoskeleton-assisted walking compared to baseline, while knee flexor activity was ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0966636222005914

Effectiveness of robotic exoskeletons for improving gait in ...

One study showed that walking with the tethered knee exoskeleton significantly (p = 0.001) increased hip extension during mid ST in comparison to Shod or AFO ...

4.

withpower.com

withpower.com/trial/pediatric-knee-exoskeleton-for-knee-hyperextension-f5927

Pediatric Knee Exoskeleton for Knee Hyperextension

The exoskeleton improved knee extensor muscle activity and showed postural improvements in six out of seven participants, with benefits increasing over the ...

5.

epic.gatech.edu

epic.gatech.edu/pediatric-knee-exoskeleton/

Pediatric Knee Exoskeleton

The primary aim of the project is to help assist the children with limited mobility mainly caused by the knee joint in walking with the help of powered ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05726591?tab=table

Researcher View | NCT05726591 | Evaluating Long-term ...

Finally, to evaluate the safety and feasibility of a community-based protocol for rehabilitation using a pediatric robotic exoskeleton. Endpoints: Primary ...

7.

science.org

science.org/doi/10.1126/scitranslmed.aam9145

A lower-extremity exoskeleton improves knee extension in ...

We show that the exoskeleton reduced crouch in a cohort of ambulatory children with CP during overground walking. The exoskeleton was safe and ...