Engaging Kids With Robotic Exoskeletons and Gamification

July 16, 2025 updated by: Kinsey Herrin, Georgia Institute of Technology

Engaging Kids and Improving Rehab Outcomes by Gamification of Robotic Exoskeletons Combined With Proprioceptive Biofeedback

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

For children, mobility is a crucial activity of daily living and age-appropriate play, influencing their independence and overall quality of life. However, children with physical disabilities often experience participation restrictions especially related to physical activity. The ICF (International Classification of Functioning, Disability and Health) notes that participation is a key contributor toward a person's overall quality of life. However, children with disabilities often experience significant participation restrictions especially related to physical activity with some studies citing that less than half of children with disabilities are physically active. Participation in physical activity allows for all the benefits associated with social engagement, belonging and autonomy, influencing a child's independence and overall development. Additionally, physical activity provides the benefits of improved health related fitness, including strength and flexibility. For children with gait impairments, lack of independence may hinder development and then compound through further loss of mobility. Some of the most encountered pediatric pathologies (CP, Spina Bifida and TBI) impact physical mobility, and clinical presentations often present with aberrant motor control of the knee. Clinical presentations may vary between genu recurvatum or crouch gaits and can be confounded with various lower limb alignment presentations as well. These abnormal walking patterns can lead to detrimental long-term effects including increased stress on soft tissue structures which often leads to permanent joint deformity if left untreated, reduced locomotion capability/ independence, increased energy expenditure and pain. The investigator team has developed an autonomous bilateral research-grade pediatric knee exoskeleton, and the investigators' data on N=10 children show the investigators have addressed an initial need for an effective pediatric knee exoskeleton from previous work. However, work is still needed to encourage: 1. real-world accessibility and usability of the device in a clinic setting outside of the research laboratory, 2. long-term retention of the intervention beyond the immediate therapeutic session, and 3. fun and active patient engagement during exoskeleton use. In this study, the investigators aim to develop and test a clinically friendly, pediatric knee exoskeleton integrated with a visual biofeedback video game to improve gait related outcomes and contribute toward improved mobility in children with walking impairment. Early intervention to engage children in their rehab along with enjoyable participation may lead to improved long-term outcomes for children and their families.

The investigators will conduct a small-scale feasibility study in which 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. Sessions will be scheduled as is convenient for the participant's schedule with a goal of having one night and no more than 1 week between consecutive sessions. Outcomes will be monitored before and after each session.

The investigators hypothesize that patient outcomes, inclusive of both functional and patient reported metrics, will significantly improve from the initial baseline visit to the final evaluation after 5 sessions of therapy. Finally, the investigators will analyze the device efficacy and family/therapist survey data to implement improvements to the exoskeleton and biofeedback game in the future.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Children's Healthcare of Atlanta - Scottish Rite
        • Contact:
        • Principal Investigator:
          • Kinsey Herrin, MSPO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
10 meter walk test
Time Frame: 5 weeks
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
Time Frame: 5 weeks
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
Time Frame: 5 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gillette Functional Assessment Questionnaire
Time Frame: 5 weeks
Family/patient reported survey which asks questions about their perception of the child's mobility.
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Georgia Institute of Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Healthcare of Atlanta

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kinsey Herrin, MSPO, Georgia Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H24360

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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