Clinical trial NCT05378243: Innovative Robotic Gait Trainer Use to Enable Walking in Children With Cerebral Palsy GMFCS III and IV
Official title: Innovative Robotic Gait Trainer Use to Enable Walking in Children With Cerebral Palsy GMFCS III and IV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: Ontario Brain Institute
name: Academic Health Science Centres
First posted: 2022-05-18
Enrollment: 10
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover trial
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

Detailed description: 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:

* Recruitment success (number screened, number eligible, number enrolled) where 80% of the recruitment target is reached.
* Attrition rates of less than 10% (i.e. ≥90% of participant's successfully complete assessments).
* Adherence for each participant: 80% of participants who complete assessments achieve the minimum target dose (i.e. approx. ≥30 hours of therapy in both study groups).
* Qualitative feedback from clinicians and patients/caregivers on device tolerability and study participation.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Enrollment and recruitment in this study design
timeFrame: 4 months
measure: Retention in this study design
timeFrame: 4 months
measure: Adherance to protocol for each participant
timeFrame: 4 months
measure: Device tolerability
timeFrame: 4 months
Secondary outcomes:
measure: 2 minute walk test (2mwt)
timeFrame: 4 months
measure: Edinburgh Visual Gait Score
timeFrame: 4 months
measure: Physiological Cost Index
timeFrame: 4 months
measure: Modified Ashworth Scale
timeFrame: 4 months
measure: Hypertonia Assessment Tool
timeFrame: 4 months
measure: Barry Albright Dystonia Scale
timeFrame: 4 months
measure: Goal attainment scale
timeFrame: 4 months
measure: Spinal Alignment and Range of Motion Measure
timeFrame: 4 months
measure: Leg Bone cortical density
timeFrame: 4 months
measure: Tibia volumetric bone mineral density (BMD)
timeFrame: 4 months
measure: Leg bone cortical cross-sectional area
timeFrame: 4 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
References: