Recruiting

Exoskeleton & Biofeedback

Sponsor:

Georgia Institute of Technology

Code:

NCT06647082

Conditions

Genu Recurvatum

Crouch Gait

Eligibility Criteria

Sex: All

Age: 4 - 21

Healthy Volunteers: Not accepted

Interventions

Pediatric Knee Exoskeleton

Study Details

Brief summary:

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.

Conditions

Genu Recurvatum

Crouch Gait

Study ID

NCT06647082

Start date

Jul 22, 2026

Status verified date

Jul, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Oct 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 4-21 years
  • Clinical presence of genu recurvatum or crouch gait during walking
  • Ability to walk nonstop for at least 6 minutes
  • Willing to participate in 5 sessions of therapy with the device with each session lasting no more than 2 hours

Exclusion Criteria:

  • Inability to take commands from research staff
  • Receipt of Botox injection during study trial will disqualify the participant from participating further
  • Presence of uncontrolled seizures
  • Non-English speaking

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Pediatric Knee Exoskeleton

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.

Interventions

Pediatric Knee Exoskeleton

The current knee exoskeleton is designed specifically for use in children. The device can be operated either bilaterally or unilaterally and is capable of providing 10- 17.4 Nm of torque assistance at the knee joint which is \~60% of the average biological joint torque for an American 15 year old child. It is adjustable in height such that the passive hip joint and powered knee joint can be placed at the correct anatomical location for each child. Thigh and calf cuffs are interchangeable to accommodate varying leg sizes. The device is autonomous, allowing a child to move freely and can even be used outdoors. The device can accommodate for varying lower limb alignment presentations, adjusting to accommodate for varying femoral rotations and varum and valgum alignments at the knee. The device can be worn independently of the visual biofeedback video game, but is intended for participants to use in conjunction with the knee exoskeleton.

Primary outcome measure

  • 10 meter walk test [ Time Frame: 5 weeks ]
  • 2 minute walk test [ Time Frame: 5 weeks ]
  • Modified Timed Up and Go [ Time Frame: 5 weeks ]

Central Contacts and Locations

Central contacts

Kinsey Herrin, MSPO

470-578-7600kinsey.herrin@gatech.edu

Locations

Children's Healthcare of Atlanta - Scottish Rite

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Kinsey Herrin, MSPO

470-578-7600kinsey.herrin@gatech.edu

Principal Investigator:

Kinsey Herrin, MSPO

More Information

Sponsor

Georgia Institute of Technology

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

  • Pediatric walking impairment
  • Exoskeleton
  • Knee exoskeleton
  • Knee hyperextension
  • Knee crouch gait

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgia Institute of Technology on 2026-07-28.