Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders

Cerebral Palsy Clinical Trial

Official title: A Phase I/II Trial Evaluating Long-Term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders

Status Recruiting

Clinical Trial Summary

Background:

People with cerebral palsy, spina bifida, muscular dystrophy, or spinal cord injury often have muscle weakness and problems controlling how their legs move. This can affect how they walk. The NIH has designed a robotic device (exoskeleton) that can be worn on the legs while walking. The wearable robot offers a new form of gait training.

Objective:

To learn whether a robotic device worn on the legs can improve walking ability in those with a gait disorder.

Eligibility:

People aged 3 to 17 years with a gait disorder involving the knee joint.

Design:

Participants will be screened. They will have a physical exam. Their walking ability will be tested.

Participants will have markers taped on their body; they will walk while cameras record their movements. They will undergo other tests of their motor function and muscle strength.

The study will be split into three 12-week phases. During 1 phase, participants will continue with their standard therapy.

During another phase, participants will work with the exoskeleton in a lab setting. Their legs will be scanned to create an exoskeleton with a customized fit. The exoskeleton operates in different modes: in exercise mode, it applies force that makes it difficult to take steps; in assistance mode, it applies force meant to aid walking; in combination mode, it alternates between these two approaches.

During the third phase, participants may take the exoskeleton home. They will walk in the device at least 1 hour per day, 5 days per week, for 12 weeks.

Participants walking ability will be retested after each phase....

Clinical Trial Description

Study Description:

This randomized crossover trial will determine whether 12 weeks of overground gait training with a robotic exoskeleton outside of the clinical setting has a beneficial effect on walking ability, muscle activity, and overall gross motor function. Participants will be randomized into two groups, one that receives the exoskeleton therapy first before crossing over to continue standard therapy and one that continues standard therapy before completing the exoskeleton intervention. An in-lab training and accommodation period will be completed prior to the exoskeleton being sent home for use outside the clinical setting. We will monitor exoskeleton use during the intervention period for compliance and safety. Assessments of gait biomechanics, neuromuscular activity and functional mobility will be completed before and after the intervention and at 6 weeks post- intervention. It is hypothesized that the 12-week exoskeleton intervention outside the clinic setting will show greater improvements than the standard therapy.

Objectives:

Primary Objective: To evaluate the effectiveness of a longitudinal robotic exoskeleton gait training paradigm in improving crouch gait from CP or knee extension deficiency from SB, iSCI or MD in children, assessed as improvement in knee angle during walking before and after the intervention period.

Secondary Objectives:

To evaluate changes in muscle strength and gait speed following longitudinal intervention with robotic exoskeleton in children with crouch gait from CP or knee extension deficiency from SB, iSCI or MD. Additionally, to evaluate the primary endpoint of knee joint range of motion at multiple time points to assess for order effect and persistence of any observed effect.

Exploratory Objectives:

To assess the effect of exoskeleton dosage (i.e., time spent using the device) on the primary endpoint.

Additionally, to evaluate change in knee extensor and flexor muscle spasticity following longitudinal intervention with a robotic exoskeleton in children with crouch gait from CP or knee extension deficiency from SB, iSCI or MD. Additionally, to asses improvement in gross motor function following the same intervention. Finally, to evaluate the safety and feasibility of a community-based protocol for rehabilitation using a pediatric robotic exoskeleton.

Endpoints:

Primary Endpoint: Knee extension as assessed by peak knee angle during midstance phase of walking.

Secondary Endpoints: Change in knee extensor muscle activation and strength after exoskeleton intervention; Change in average gait speed after exoskeleton intervention; Persistence of the primary endpoint (change in knee angle) at 6 weeks post intervention; Effect of order of standard therapy and exoskeleton intervention.

Exploratory Endpoints:

Effect of exoskeleton intervention dosage on change in peak knee angle during walking; Change in knee extensor and flexor spasticity after exoskeleton intervention; Improvement in gross motor function after exoskeleton intervention; Feasibility and safety of exoskeleton use outside clinical setting assessed by participant compliance and occurrence of adverse events, respectively. ;

Related Conditions & MeSH terms

• Cerebral Palsy
• Incomplete Spinal Cord Injury
• Movement Disorders
• Muscular Dystrophies
• Muscular Dystrophy
• Spina Bifida
• Spinal Cord Injuries
• Spinal Dysraphism

• NCT number: NCT05726591
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Thomas C Bulea, Ph.D.
• Phone: (301) 451-7533
• Email: buleatc@mail.nih.gov
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2023
• Completion date: October 31, 2027