Clinical trial NCT06647082: Engaging Kids With Robotic Exoskeletons and Gamification
Official title: Engaging Kids and Improving Rehab Outcomes by Gamification of Robotic Exoskeletons Combined With Proprioceptive Biofeedback
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Genu Recurvatum
Crouch Gait
Keywords: Pediatric walking impairment
Exoskeleton
Knee exoskeleton
Knee hyperextension
Knee crouch gait
Lead sponsor: Georgia Institute of Technology
Sponsor class: OTHER
Collaborators: name: Children's Healthcare of Atlanta
First posted: 2024-10-17
Enrollment: 5
Sex: ALL
Minimum age (years): 4
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 10 meter walk test
timeFrame: 5 weeks
measure: 2 minute walk test
timeFrame: 5 weeks
measure: Modified Timed Up and Go
timeFrame: 5 weeks
Secondary outcomes:
measure: Gillette Functional Assessment Questionnaire
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta - Scottish Rite
state: Georgia
Study officials:
affiliation: Georgia Institute of Technology
name: Kinsey Herrin, MSPO
role: PRINCIPAL_INVESTIGATOR
References: