Genu RecurvatumNCT06647082
Engaging Kids With Robotic Exoskeletons and Gamification
A study testing Pediatric Knee Exoskeleton in people with Genu Recurvatum and Crouch Gait, run by Georgia Institute of Technology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 21 years
- Conditions the study is for
- Genu Recurvatum, Crouch Gait
- What is being tested?
- Pediatric Knee Exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia, 30342
Kinsey Herrin, MSPO, 470-578-7600, kinsey.herrin@gatech.edu
Kinsey Herrin, MSPO
About this study
Official title: 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.
Read the 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.
- Conditions
- Genu Recurvatum, Crouch Gait
- Being tested
- Pediatric Knee Exoskeleton
- Keywords
- Pediatric walking impairment, Exoskeleton, Knee exoskeleton, Knee hyperextension, Knee crouch gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Knee ExoskeletonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Pediatric Knee Exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 5 weeks
Secondary outcomes (1)
Gillette Functional Assessment Questionnaire
Family/patient reported survey which asks questions about their perception of the child's mobility.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start22 Jul 2026
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genu RecurvatumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgia Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Responsible party
- Principal investigator, Kinsey Herrin, Georgia Institute of Technology
- Investigators
- Kinsey Herrin, MSPO, Principal investigator, Georgia Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647082
- Sponsor's protocol ID
- H24360
- Status last verified
- Jul 2026
- First submitted
- 16 Oct 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Kids and Improving Rehab Outcomes by Gamification of Robotic Exoskeletons Combined With Proprioceptive Biofeedback
- ClinicalTrials.gov ID
- NCT06647082
- Acronym / sponsor ID
- H24360
- Conditions
- Genu Recurvatum, Crouch Gait
- Keywords
- Pediatric walking impairment, Exoskeleton, Knee exoskeleton, Knee hyperextension, Knee crouch gait
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Georgia Institute of TechnologyUniversity, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Knee Exoskeleton | Experimental | Device: Pediatric Knee ExoskeletonN=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 may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pediatric Knee ExoskeletonThe 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. | Device | Pediatric Knee Exoskeleton |
Primary outcome
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.
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.
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.
1 secondary outcome
Gillette Functional Assessment Questionnaire
Time frame: 5 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Genu Recurvatum
Enrolling by invitation
Comparison of Open Vs Closed Kinetic Chain Exercises in Genu Recurvatum Among Stroke Patients
Cerebrovascular Accident (Stroke), Knee Hyperextension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kinsey Herrin, MSPO principal investigator
Georgia Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric Knee Exoskeleton in people with Genu Recurvatum and Crouch Gait, run by Georgia Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kinsey Herrin, MSPO (470-578-7600, kinsey.herrin@gatech.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 meter walk test (time frame: 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.