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Completed

NCT Number: NCT05473676

Robotic Walking for Children Who Cannot Walk

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Brain Injuries Central Nervous System Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniocerebral Trauma Mobility Limitation Nervous System Diseases Nervous System Malformations Neural Tube Defects Pathological Conditions, Signs and Symptoms Signs and Symptoms Spina Bifida Spinal Cord Diseases Spinal Cord Injuries Spinal Dysraphism Trauma, Nervous System Wounds and Injuries

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Calgary, Alberta, T3B 6A8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Training Time

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

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

  2. Training Frequency

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

    Frequency of training sessions (days/week).

  3. Canadian Occupational Performance Measures (COPM)

    Time frame: 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).

    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.

  4. Goal Attainment Scaling

    Time frame: 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).

    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.

  5. Early Clinical Assessment of Balance (ECAB)

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

    Clinical balance assessment to determine participant's balance capabilities.

Secondary outcomes

  1. Number of Participants Enrolled and Completed

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

    Assessment of number of participants that start the study and how many are able to complete the study.

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

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

    Qualitative assessment of impacts of robotic gait training on participants and families.

  3. EQ-5D-Y (Youth)

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

    Qualitative assessment of impacts of robotic gait training on participants and families.

  4. CarerQOL

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

    Qualitative assessment of impacts of robotic gait training on participants and families.

  5. Focus Groups

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

    Semi-structured interviews with participants and families and/or caregivers. Themes will include independence in daily function and feedback on training with the device.

  6. Head Control While Walking

    Time frame: Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28)..

    Head angle from vertical will be measured to determine if head control is impacted by training.

  7. Seated Limits of Stability

    Time frame: Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28).

    Forward, backward, and side to side leaning will be assessed to evaluate trunk strength and control.

  8. Ramp & Hold

    Time frame: Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28).

    Evaluation of stiffness and involuntary muscle activity, recorded using electromyography (EMG) or mechanomyography (MMG).

  9. Voluntary Muscle Activity

    Time frame: Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28).

    Evaluation of voluntary muscle contractions. Recorded using EMG or MMG.

  10. Modified Tardieu Scale

    Time frame: Assessed monthly from time of enrollment (Week 0) through to 3-months post-training (~Week 28).

    Clinician movement of joint to determine range of motion and angle of catch at the joint. Joint neutral is defined as 0 degrees, where any range beyond neutral is recorded in "+" degrees and any range not reaching neutral is recorded in "-" degrees.

  11. Habitual Activity Estimation Scale (HAES)

    Time frame: Assessed monthly from time of enrollment (Week 0) through to 3-months post-training (~Week 28).

    Participant or proxy report of estimated physical activity during a typical weekday and week-end day. Participants or proxy report a percentage of time spent inactive, somewhat inactive, somewhat active, and active on a typical weekday and week-end day.

  12. PROMIS Sleep Disturbance Questionnaire

    Time frame: Assessed monthly from time of enrollment (Week 0) through to 3-months post-training (~Week 28).

    Participant or proxy report of sleep disturbances. Participants or a proxy will rate different sleep scenarios on a 5 point scale, 1 being Never and 5 being Always.

  13. Heart Rate Reserve

    Time frame: Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28

    Week-long assessment measuring heart rate, tracked using Actigraph wearable sensor worn on chest and wrist.

  14. Distance Walked

    Time frame: Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28

    Week-long assessment measuring heart rate, tracked using inertial measurement units (IMUs) worn on feet.

  15. Sleep Duration

    Time frame: Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28

    Week-long assessment measuring heart rate, tracked using Actigraph wearable sensor worn on chest and wrist.

  16. Bowel Function

    Time frame: Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28

    Week-long assessment measuring frequency and quality of bowel movements as well as any interventions used to facilitate bowel movements, for example medications. Tracked using participant or proxy reports in a daily diary provided by study team.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Acronym: RoWaCaWa

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 26, 2022
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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