Robotic Walking for Children Who Cannot Walk

NCT05473676 | Completed

• 1 other identifier: REB21-1166
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Keywords

Robot Assisted Gait Training; Trexo; Rehabilitation; Robotic Training; Assisted Walking

Outcome Measures

Primary Outcomes (5)

• Training Time

  Time spent in the trainer each session, total time spent in the trainer (weekly, monthly).

  Assessed throughout the 12 weeks (Week 5 through Week 16) robotic training period.

• Training Frequency

  Frequency of training sessions (days/week).

  Assessed throughout the 12 week (Week 5 through Week 16) robotic training period.

• Canadian Occupational Performance Measures (COPM)

  Structured questions and rating scales to determine problem areas and goals for training. Identified problems are scored on a 10 point scale, 1 being not able to complete the task at all.

  Assessed at enrollment (Week 0), before Robotic Gait Training period (~Week 4), following Robotic Gait Training period (~Week 16), and at 3-months post-training (~Week 28).

• Goal Attainment Scaling

  Rating of success in achieving an outcome or desired goal (identified using the COPM), where 0 = the expected level of achievement, -2 = much less achieved than expected, and +2 = much more achieved than expected.

  Assessed at enrollment (Week 0), before Robotic Gait Training period (~Week 4), following Robotic Gait Training period (~Week 16), and at 3-months post-training (~Week 28).

• Early Clinical Assessment of Balance (ECAB)

  Clinical balance assessment to determine participant's balance capabilities.

  Assessed monthly from time of enrollment through 3-months post-training.

Secondary Outcomes (16)

• Number of Participants Enrolled and Completed

  Assessed throughout the study duration, an average of 7-9 months depending on time of enrollment..

• Caregiver Priorities & Child Health Index of Life with Disabilities (CP-CHILD)

  Assessed before (~Week 4) and after (~Week 16) robotic gait training.

• EQ-5D-Y (Youth)

  Assessed before (~Week 4) and after (~Week 16) robotic gait training.

• CarerQOL

  Assessed before (~Week 4) and after (~Week 16) robotic gait training.

• Focus Groups

  Assessed before (~Week 4) and after (~Week 16) robotic gait training.

Study Arms (1)

Robotic Training Period

EXPERIMENTAL

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.

Device: Robotic Training Period

Interventions

Robotic Training Period 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.

Robotic Training Period

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

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

Calgary, Alberta, T3B 6A8, Canada

Location

MeSH Terms

Conditions

Cerebral Palsy; Mobility Limitation; Brain Injuries; Spinal Cord Injuries; Spinal Dysraphism

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Diseases; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Elizabeth G Condliffe, MD, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Because there is only 1 arm in the study, and each participant proceeds through the same study timeline, participants, care providers, investigators, and outcome assessors will know the intervention received.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Model Details: All participants will proceed through the same study timeline from the time of enrollment.

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: July 26, 2022
• Study Start: July 4, 2022
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: January 14, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will become available at the end of the study. There is no plan to close the database.
• Access Criteria: Researchers requesting access to the database will be required to sing a Terms of Use agreement.

Locations

CA (1)