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

5 Participants Needed

Trial Summary

What is the purpose of this trial?

Conduct a clinical field trial at CHOA's Day Rehab Program using the clinical exoskeleton in conjunction with visual biofeedback with pediatric patients who present with genu recurvatum or crouch gait over 5 rehabilitation visits.

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.

How does the Pediatric Knee Exoskeleton treatment differ from other treatments for knee hyperextension in children?

The Pediatric Knee Exoskeleton is unique because it provides real-time adaptive control and individualized assistance for knee extension during walking, which can be used at home, unlike traditional therapies that are often clinic-based. This wearable device dynamically adjusts to the user's needs, offering a novel approach to improve walking in children with conditions like cerebral palsy. ^{1 2 3 4 5}

Research Team

Kinsey Herrin, MSPO

Principal Investigator

Georgia Institute of Technology

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Design Advancements toward a Wearable Pediatric Robotic Knee Exoskeleton for Overground Gait Rehabilitation. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A Pediatric Knee Exoskeleton With Real-Time Adaptive Control for Overground Walking in Ambulatory Individuals With Cerebral Palsy. [2022]

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

Interleaved Assistance and Resistance for Exoskeleton Mediated Gait Training: Validation, Feasibility and Effects. [2023]

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

A Robotic Exoskeleton for Treatment of Crouch Gait in Children With Cerebral Palsy: Design and Initial Application. [2021]

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

A lower-extremity exoskeleton improves knee extension in children with crouch gait from cerebral palsy. [2023]