Health TrialsbyHealthPanel

Engaging Kids With Robotic Exoskeletons and Gamification

ConditionsGenu RecurvatumCrouch Gait
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-21
SponsorGeorgia Institute of Technology

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: Pediatric Knee ExoskeletonExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
5 weeks
2

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.

Time frame
5 weeks
3

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.

Time frame
5 weeks

Secondary outcomes

1

Gillette Functional Assessment Questionnaire

Family/patient reported survey which asks questions about their perception of the child's mobility.

Time frame
5 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Georgia Institute of Technology

Lead sponsor

Children's Healthcare of Atlanta

Collaborator

Source ClinicalTrials.gov
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