Children Unable to Walk Independently
Conditions
Brief summary
Robot-assisted walking offers children who are unable to walk new avenues for participation in their communities in addition to health benefits. Disappointingly, most children cannot access this impactful technology. One of every 1000 children cannot walk due to cerebral palsy,1 and many others cannot walk due to less common neurodevelopmental disorders such as Spina Bifida or Rett Syndrome. The inability to walk impacts most areas of daily life. Despite this large need, there are few, if any, interventions available to facilitate participation and motor function.2-4 Recently, the study team have learned that robot-assisted walking can improve motor function and reduce the health impacts of physical inactivity that these children often experience. Robot assisted walking aids attach to a walker and use robotic legs to power a child's leg movements, allowing them to use their body in new ways from an upright position. When used in home and community settings, it also creates new avenues for participation in daily life that are critical for supporting cognitive, communication and social development. However, this technology is expensive and requires adult support, limiting access to families with adequate resources. The need exists to create equitable opportunities to access robot-assisted walking to improve multidimensional outcomes for children who cannot walk. Many innovative rehabilitation interventions do not cross the chasm from evidence to implementation. Knowing this risk, this program is strategically using implementation science methods to identify and study strategies to support implementation. Through previous studies, school settings have been identified as optimal for facilitating equitable access to robot-assisted walking to promote participation and function-based improvements. The research team conducted a study to identify barriers and facilitators to implementation in a school setting and have subsequently selected strategies to address the barriers and leverage the facilitators. Before confidently launching a planned multisite trial to examine implementation and effectiveness of robot-assisted walking in the school setting, the research team needs to pilot the implementation strategies within the planned study design. The proposed pilot study will optimize research methods to ensure a future multisite trial provides the necessary evidence for sustainable school implementation and equitable access to robot-assisted walking.
Interventions
DEVICERobotic walking
Use of a robotic walking aid will be provided to participants by qualified school therapists and staff
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Enrolled at a participating study site. * Fit a robotic walking device.
Exclusion criteria
* Does not fit a robotic walking device. * Displays a contraindication to robotic walking.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Consolidated Framework for Implementation Research (CFIR) | From the date of enrollment until the date of completion of both study arms, up to 12 months. | The structure to generate and evaluation of implementation barriers and facilitators. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early Clinical Assessment of Balance (ECAB) | From the date of enrollment until the date of completion of both study arms, up to 12 months. | Ordinal scale evaluated through a clinical assessment testing various aspects of balance. |
| Canadian Occupational Performance Measure (COPM) | From the date of enrollment until the date of completion of both study arms, up to 12 months. | A structured interview that guides goal selection at the beginning of the study with a patient-reported ordinal outcome to evaluate at key timepoints (before and after an intervention arm). Participants/families rate their performance and satisfaction regarding each goal on a 10-point scale (1-10). |
Countries
Canada
Outcome results
None listed