Engaging Kids With Robotic Exoskeletons and Gamification

NCT06647082 | Not Yet Recruiting FDA Device

• 1 other identifier: H24360
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 10 meter walk test

  The participant walks a 10 meter distance while their speed is recorded. Higher speeds are indicative of a more positive outcome.

  5 weeks

• 2 minute walk test

  The participant walks as far as they can walk in a period of 2 minutes and the distance is recorded. Greater distances are indicative of improved performance.

  5 weeks

• Modified Timed Up and Go

  Participants are seated in a stable stool selected according to the height of subjects. The stool is positioned such that it does not move when the participant moves from sitting to standing. Participant is seated with feet flat on the floor in such a way that hip and knee remained in 90° of flexion. A marking tape was used to stick a star mark on the wall at a distance of 3 m from the chair. Participant is instructed to stand up, walk, touch the star and sit back down while being timed. Shorter times are indicative of improved performance.

  5 weeks

Secondary Outcomes (1)

• Gillette Functional Assessment Questionnaire

  5 weeks

Study Arms (1)

Pediatric Knee Exoskeleton

EXPERIMENTAL

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.

Device: Pediatric Knee Exoskeleton

Interventions

Pediatric Knee Exoskeleton DEVICE

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.

Pediatric Knee Exoskeleton

Eligibility Criteria

• Age: 4 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgia Institute of Technology: lead
• Children's Healthcare of Atlanta: collaborator

Study Sites (1)

Children's Healthcare of Atlanta - Scottish Rite

Atlanta, Georgia, 30342, United States

Location

Study Officials

• Kinsey Herrin, MSPO

  Georgia Institute of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kinsey Herrin, MSPO

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 17, 2024
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)