Parent-therapist partnership to ELEVATE gross motor function in children with perinatal stroke: protocol for a mixed methods randomized controlled trial.

BACKGROUND: There is increasing evidence for early, active rehabilitation to enhance motor function following early brain injury. This is clear for interventions targeting the upper extremity, whereas passive treatment approaches for the lower extremity persist. The purpose of this trial is to evaluate the effectiveness of early, intensive rehabilitation targeting the lower extremity and delivered in a parent-therapist partnership model for children with perinatal stroke. METHODS: We describe a protocol for a waitlist-control, single-blind, mixed methods effectiveness randomized controlled trial, with an embedded qualitative study using interpretative description. Participants are children with perinatal stroke aged eight months to three years with signs of hemiparesis. Participants will be randomly allocated to an immediate ELEVATE (Engaging the Lower Extremity Via Active Therapy Early) intervention group, or a waitlist-control group, who will receive usual care for six months. The ELEVATE intervention involves one hour of training four days per week for 12 weeks, with a pediatric therapist and a parent or guardian each delivering two sessions per week. The intervention targets the affected lower extremity by progressively challenging the child while standing and walking. The primary outcome measure is the Gross Motor Function Measure-66. Secondary outcomes include the Pediatric Quality of Life Inventory™, Young Children's Participation and Environment Measure, and an instrumented measure of spasticity. A cost-effectiveness analysis and qualitative component will explore benefit to costs ratios and parents' perspectives of early, intensive rehabilitation, and their role as a partner in the rehabilitation, respectively. DISCUSSION: This study has the potential to change current rehabilitation for young children with perinatal stroke if the ELEVATE intervention is effective. The parent interviews will provide further insight into benefits and challenges of a partnership model of rehabilitation. The mixed methods design will enable optimization for transfer of this collaborative approach into physical therapy practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03672864 . Registered 17 September 2018.

Robotic lower extremity exoskeleton use in a non-ambulatory child with cerebral palsy: a case study.

PURPOSE: With few treatment options available for non-ambulatory children with cerebral palsy (CP), a robotic lower extremity gait trainer may provide a non-invasive addition to conventional treatment options. This case study investigates the usage and impact of robotic lower extremity gait trainer use in a participant with CP over the initial 3 months of use. MATERIALS AND METHODS: This prospective case study involves a 7-year old female (GMFCS V) with CP (registered clinical trial: NCT04251390). The participant used a Trexo Home robotic gait trainer (Trexo) in the community with assessments occurring in the home and school. Trexo usage and bowel movements (BMs) were tracked daily. Postural control and lower extremity range of motion (ROM) and spasticity were evaluated prior to Trexo use and weekly to biweekly thereafter. RESULTS: The participant used the device an average of 46 min/week, over 3.3 d/week. BM frequency increased from 0.4/d at baseline, to 1.2 (±0.5)/d during Trexo use. There were no diffuse systematic changes in postural stability, ROM or muscle spasticity, but specifically head control and spasticity in the knee flexors had improvements. CONCLUSIONS: Data and anecdotal reports suggest that regular use of the Trexo Home robotic gait trainer has positive outcomes on frequency and quality of BMs, and may improve head control, and knee flexor spasticity. Larger controlled studies are needed to evaluate the impacts of Trexo use in children with CP.Implications for RehabilitationNon-ambulatory children with CP can use and may experience benefits from using a robot-assisted gait trainer (RAGT).Constipation, aspects of balance and focal spasticity may improve.

Robot-Assisted Gait Training with Trexo Home: Users, Usage and Initial Impacts.

Robotic gait training has the potential to improve secondary health conditions for people with severe neurological impairment. The purpose of this study was to describe who is using the Trexo robotic gait trainer, how much training is achieved in the home and community, and what impacts are observed after the initial month of use. In this prospective observational single-cohort study, parent-reported questionnaires were collected pre- and post-training. Of the 70 participants, the median age was 7 years (range 2 to 24), 83% had CP, and 95% did not walk for mobility. Users trained 2-5 times/week. After the initial month, families reported a significant reduction in sleep disturbance (p = 0.0066). Changes in bowel function, positive affect, and physical activity were not statistically significant. These findings suggest that families with children who have significant mobility impairments can use a robotic gait trainer frequently in a community setting and that sleep significantly improves within the first month of use. This intervention holds promise as a novel strategy to impact multi-modal impairments for this population. Future work should include an experimental study design over a longer training period to begin to understand the relationship between training volume and its full potential.