Cerebral Palsy Clinical Trial
Official title:
Innovative Robotic Gait Trainer Use to Enable Walking in Children With Cerebral Palsy GMFCS III and IV
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | July 31, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 12 Years |
Eligibility | Inclusion Criteria: - Patients with a diagnosis of cerebral palsy - GMFCS Levels III and IV - Ages =2 to =12 years - Ability to take steps with and/or without assistance - Meet the Trexo Plus device size requirements - Ability to follow instructions and signal pain, fear, or discomfort - Ability to safely use the device at home as determined by the study team Exclusion Criteria: - Lower limb or orthopedic surgery within 9 months prior to enrollment - Botulinum toxin injections within 4 months prior to enrollment - Serial casting within 3 months prior to enrollment - Knee flexion contracture > 20° - Knee valgus > 40° - Hip subluxation > 40 % migration percentage - Uncontrolled movements that prevent transfer in and/or out of device - Weight bearing restrictions - Uncontrolled seizures - Skin lesions in areas where the device straps would be attached - Significant language barrier with parents and/or caregivers Note: children with severe contractures will be unable to fit in the device and are therefore excluded from the study |
Country | Name | City | State |
---|---|---|---|
Canada | Children's Hospital of Eastern Ontario | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Eastern Ontario | Academic Health Science Centres, Ontario Brain Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Enrollment and recruitment in this study design | Recruitment success as defined by meeting 80% of the recruitment target | 4 months | |
Primary | Retention in this study design | Attrition of less than 10% where 90% of participants are completing the assessments to the end of the trial | 4 months | |
Primary | 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 | 4 months | |
Primary | Device tolerability | Participant caregivers will be interviewed for qualitative feedback on device/therapy tolerability after each 8 week session | 4 months | |
Secondary | 2 minute walk test (2mwt) | distance child is able to walk in their own walker in 2 minutes | 4 months | |
Secondary | 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 | 4 months | |
Secondary | 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 | 4 months | |
Secondary | 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. | 4 months | |
Secondary | 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. | 4 months | |
Secondary | 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. | 4 months | |
Secondary | 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 | 4 months | |
Secondary | 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. | 4 months | |
Secondary | Leg Bone cortical density | peripheral Quantitative Computed Tomography (pQCT) Measures Cortical density (mg/cm2) | 4 months | |
Secondary | Tibia volumetric bone mineral density (BMD) | peripheral Quantitative Computed Tomography (pQCT) Measures Tibia volumetric bone mineral density (BMD) (mg/cm2) | 4 months | |
Secondary | Leg bone cortical cross-sectional area | peripheral Quantitative Computed Tomography (pQCT) Measures cortical cross-sectional area (mm2) | 4 months |
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