An interventional study of Robotic Training Period in Cerebral Palsy, Mobility Limitation and Brain Injuries, sponsored by University of Calgary. Completed at 1 site in Canada. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2025-01-14.
Sponsored by University of Calgary · Not applicable, Interventional, and Treatment
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.
2,114 studies on the registry are indexed under Brain Injuries; 386 are open to participants now.
This study's enrollment of 19 is below the median of 48 across 1,332 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
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Exclusion Criteria:
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
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.
Training Time
Time spent in the trainer each session, total time spent in the trainer (weekly, monthly).
Time frame: Assessed throughout the 12 weeks (Week 5 through Week 16) robotic training period.
Training Frequency
Frequency of training sessions (days/week).
Time frame: 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.
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).
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.
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).
Early Clinical Assessment of Balance (ECAB)
Clinical balance assessment to determine participant's balance capabilities.
Time frame: Assessed monthly from time of enrollment through 3-months post-training.
Number of Participants Enrolled and Completed
Assessment of number of participants that start the study and how many are able to complete the study.
Time frame: 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)
Qualitative assessment of impacts of robotic gait training on participants and families.
Time frame: Assessed before (~Week 4) and after (~Week 16) robotic gait training.
EQ-5D-Y (Youth)
Qualitative assessment of impacts of robotic gait training on participants and families.
Time frame: Assessed before (~Week 4) and after (~Week 16) robotic gait training.
CarerQOL
Qualitative assessment of impacts of robotic gait training on participants and families.
Time frame: Assessed before (~Week 4) and after (~Week 16) robotic gait training.
Focus Groups
Semi-structured interviews with participants and families and/or caregivers. Themes will include independence in daily function and feedback on training with the device.
Time frame: Assessed before (~Week 4) and after (~Week 16) robotic gait training.
Head Control While Walking
Head angle from vertical will be measured to determine if head control is impacted by training.
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)..
Seated Limits of Stability
Forward, backward, and side to side leaning will be assessed to evaluate trunk strength and control.
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).
Ramp & Hold
Evaluation of stiffness and involuntary muscle activity, recorded using electromyography (EMG) or mechanomyography (MMG).
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).
Voluntary Muscle Activity
Evaluation of voluntary muscle contractions. Recorded using EMG or MMG.
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).
Modified Tardieu Scale
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.
Time frame: Assessed monthly from time of enrollment (Week 0) through to 3-months post-training (~Week 28).
Habitual Activity Estimation Scale (HAES)
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.
Time frame: Assessed monthly from time of enrollment (Week 0) through to 3-months post-training (~Week 28).
PROMIS Sleep Disturbance Questionnaire
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.
Time frame: Assessed monthly from time of enrollment (Week 0) through to 3-months post-training (~Week 28).
Heart Rate Reserve
Week-long assessment measuring heart rate, tracked using Actigraph wearable sensor worn on chest and wrist.
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
Distance Walked
Week-long assessment measuring heart rate, tracked using inertial measurement units (IMUs) worn on feet.
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
Sleep Duration
Week-long assessment measuring heart rate, tracked using Actigraph wearable sensor worn on chest and wrist.
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
Bowel Function
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.
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
Plan to share: Yes — There is an Open Science plan to share de-identified IPD. All data collected in this study will be de-identified and added to a robotic training database. Access by other researchers must be requested, and agree to a Terms of Use agreement before access is granted.
Supporting information: Study protocol, Csr
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