An interventional study of Robotic Gait Training and Functional Clinical Therapy in Cerebral Palsy, sponsored by Children's Hospital of Eastern Ontario. Recruiting at 1 site in Canada. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-08-29.
Sponsored by Children's Hospital of Eastern Ontario · Not applicable, Interventional, and Device feasibility
Exploration to optimize mixed quantitative and qualitative methodology using multiple outcome measures in a randomized, cross-over trial structure comparing the effect of robotic gait training (RGT) group, and functional clinical therapy (FCT) using each subject as their own control.
Exploration to optimize mixed quantitative and qualitative methodology using multiple outcome measures in a randomized, cross-over trial structure comparing the effect of robotic gait training (RGT) group, and functional clinical therapy (FCT) using each subject as their own control.
The primary objective is to assess feasibility of the study design and device tolerability. Specifically:
Secondary objectives will evaluate the distance a child can walk in two minutes using the Two Minute Walk Test (2MWT, 18) and will examine a more global impact of the use of this technology. Data collected will include quality of gait, child or proxy chosen individualized goals, hypertonicity, contractures, and bone health.
1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.
This study's planned enrollment of 10 is below the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Children's Hospital of Eastern Ontario is the lead sponsor of 83 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
8 weeks of therapy with the robotic gait training device 4-5 times a week for 1 hour each session
Device: Robotic Gait Training
8 weeks of therapy with a custom designed therapy program for the participant's needs 4-5 times a week for 1 hour each session
Behavioral: Functional Clinical Therapy
Use of a walker adapted with robotic components to promote proper walking gait
Personalized program of physical therapy targeted to improving walking gait
Enrollment and recruitment in this study design
Recruitment success as defined by meeting 80% of the recruitment target
Time frame: 4 months
Retention in this study design
Attrition of less than 10% where 90% of participants are completing the assessments to the end of the trial
Time frame: 4 months
Adherance to protocol for each participant
Participant self-reported session diaries will be assessed to determine whether participants are achieving the min target dose of 30h of therapy over each 8 week session
Time frame: 4 months
Device tolerability
Participant caregivers will be interviewed for qualitative feedback on device/therapy tolerability after each 8 week session
Time frame: 4 months
2 minute walk test (2mwt)
distance child is able to walk in their own walker in 2 minutes
Time frame: 4 months
Edinburgh Visual Gait Score
Edinburgh Visual Gait Score is used for assessing gait quality by assessing body positions and angles of various body parts through the gait pattern using a scale of 0-2 for each individual component of the assessment. A score of 0 indicates a more physiologically normal result while a score of 2 indicates a more disordered result. The scores are totaled to provide the complete score for the patient on this assessment
Time frame: 4 months
Physiological Cost Index
assessing gait efficiency by looking at the heart rate changes upon a specified exertional task. A lower physiological cost index indicates less exertion required to complete the task
Time frame: 4 months
Modified Ashworth Scale
The Modified Ashworth Scale measures resistance during passive soft tissue stretching. It is ranked by body part on a scale of 0-4 with 0 being a normal tone and 4 being highly rigid in flexion or extension.
Time frame: 4 months
Hypertonia Assessment Tool
Assessing dystonia, spasticity, and rigidity, or a mixed tone through a rating scale system where 0 indicates the behavior is not observed and 1 indicates the dystonic/spastic/rigid behavior is observed.
Time frame: 4 months
Barry Albright Dystonia Scale
Assessing dystonia and severity of dystonia in eyes, mouth, neck, trunk, each upper extremity and each lower extremity. Scored from 0-4 where 0 is an absence of dystonia and 4 is a high degree of dystonia.
Time frame: 4 months
Goal attainment scale
Attainment of self-determined goals for treatment outcomes. Goals are set with the study therapists at the outset of each treatment period and assessed using a scale of -2 to +2 where a score of 0 is the expected outcome, a negative score indicates less than expected and a positive number indicates more than expected
Time frame: 4 months
Spinal Alignment and Range of Motion Measure
Range of motion throughout the body is measured from 0-4 where 0 is no limitation and 4 is a severe limitation.
Time frame: 4 months
Leg Bone cortical density
peripheral Quantitative Computed Tomography (pQCT) Measures Cortical density (mg/cm2)
Time frame: 4 months
Tibia volumetric bone mineral density (BMD)
peripheral Quantitative Computed Tomography (pQCT) Measures Tibia volumetric bone mineral density (BMD) (mg/cm2)
Time frame: 4 months
Leg bone cortical cross-sectional area
peripheral Quantitative Computed Tomography (pQCT) Measures cortical cross-sectional area (mm2)
Time frame: 4 months
Plan to share: No — There is no intention to share IPD with other researchers
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Hospital of Eastern Ontario