Robotic Walking for Children Who Cannot Walk

NCT ID: NCT05473676

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-04
• Study Completion Date: 2024-06-28

Brief Summary

A common problem among children with nervous system disorders is difficulty walking on their own. This has impacts beyond mobility including short and long-term health conditions associated with physical inactivity and different developmental experiences as a result of the mobility impairments. A robotic trainer can both provide rehabilitation and be an assistive device to help compensate for difficulties. Figuring out how to prescribe it is critical to improve daily life for children with significant disabilities. Preliminary use of robotic trainers have shown many benefits, such as better head control and improved independence in transfers, which greatly increases ability to live independently. Additionally, vital functions that are frequently impaired in those with less physical activity, such as sleep and bowel habits, seem to improve. Finally, these children enjoy using them.

This project aims to determine who is most likely to benefit from training with a robotic trainer and investigate key details about the dose of training that is needed. Families that are already using or hope to use robotic training need this data to help improve their access to the intervention. Clinicians need this systematic approach to building evidence to ensure a future multi-centre randomized control trial is well designed. This study is needed to help improve the lives of those who live with significant disabilities. The objective is to evaluate the feasibility and impacts of delivering robotic gait training at home. Integral in this study is capturing the user perspectives. This will both provide preliminary evidence-based advice to potential users, their families, and clinicians as well as provide key metrics to design a definitive multi-centre randomized control trial.

The investigators will provide robotic gait trainers, specifically Trexo robotic gait trainers, to participants and their families to use in their home communities for 12 weeks to evaluate the feasibility and impacts of intensive robotic gait training in people who cannot walk independently. Assessments will be completed throughout the duration of study, including before, during, and after the training intervention, with the goal of evaluating a wide range of feasibility considerations and impacts from robotic training.

Conditions

Cerebral Palsy; Mobility Limitation; Brain Injuries; Spinal Cord Injuries; Spina Bifida

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic Training Period

Participants will engage in robot assisted gait training on at least 5 days/week for at least 30 minutes each day, for a total period of 12 weeks.

Group Type: EXPERIMENTAL

Robotic Training Period

Intervention Type: DEVICE

Participants will engage in robot assisted gait training on at least 5 days/week for at least 30 minutes each day, for a total period of 12 weeks.

Interventions

Robotic Training Period

Participants will engage in robot assisted gait training on at least 5 days/week for at least 30 minutes each day, for a total period of 12 weeks.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• At least 4 years of age
• Unable to walk independently due to pediatric onset, non-progressive central nervous system disorder or injury (ie. cerebral palsy or acquired brain injury)
• Able to fit into Trexo robotic gait trainer (both leg length and weight)
• Able to fulfill training requirements throughout training period (5 days/week for at least 30 minutes each session)
• Able to comply with study procedures (assessments, training)

Exclusion Criteria

• Medical condition or recent surgery requiring lower extremity immobilization or weight-bearing restrictions (ie. fracture, unstable hip subluxation).
• Medical condition requiring a physical activity restriction (ie. unstable arrhythmia).
• Pain or symptomatic hypotension while standing.
• Contracture such that the Trexo robotic gait trainer does not result in forward movement.
• Current involvement in a potentially confounding intervention (determined on a case-by-case basis).

• Minimum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Condliffe, PhD MD

Assistant Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth G Condliffe, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Pediatric Onset of Neuromotor Impairments Lab, Alberta Children's Hospital

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

REB21-1166

Identifier Type: -

Identifier Source: org_study_id