N/A
N=19
Intensive Home-based Treadmill Training and Walking Attainment in Young Children With Cerebral Palsy
Cerebral Palsy
Bottom Line
View on ClinicalTrials.gov: NCT02424526 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Gross Motor Function Measure Dimension E — 15.6; 12.7; 18.7; 17.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- home-based treadmill training (Other); Treadmill (Device)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- California State University, Sacramento
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gross Motor Function Measure Dimension E |
15.6; 12.7; 18.7; 17.1; 16.2; 14.1 | — |
| PRIMARY Walking Activity Measured by StepWatch |
39.43; 25.09; 83.33; 18.01; 132.00; 41.19 | — |
| PRIMARY Gross Motor Function Measure Dimension D |
5.11; 5.30; 8.22; 8.72; 12.67; 12.94 | — |
| SECONDARY Pediatric Evaluation of Disability Index-Mobility Subscale |
3.80; 5.44; 6.89; 7.51; 11.63; 14.00 | — |
| SECONDARY Timed 10-meter Walk Test |
-24.86; -36.23; -28.16; -49.65; -46.99; -38.80 | — |
| SECONDARY Peabody Developmental Motor Scales-2 -Locomotion Subscale |
5.67; 6.70; 8.33; 9.21; 14.11; 13.99 | — |
| SECONDARY 1-minute Walk Test |
8.28; 7.87; 12.38; 9.48; 15.37; 16.15 | — |
Summary
This study is designed to find the optimal dosage of home-based treadmill training needed to accelerate walking onset and to examine the long-term effects on the child's walking activity.
Eligibility Criteria
Inclusion Criteria
- Signs of walking readiness as demonstrated by the ability to sit for 30 seconds when placed and to take 5 to 7 steps when supported at the trunk or arms.
- Because young children often are not formally diagnosed with CP until 2 years of age, we will include children
- who show bilateral impairment (i.e. diplegia and quadriplegia, but not hemiplegia)
- who demonstrate upper motor neuron signs (i.e. spasticity and/or hyperreflexia)
- who have been identified as high-risk for a motor disability by a physician
Exclusion Criteria
- a history of uncontrolled seizures
- a diagnosis of a genetic disorder
- cardiac or orthopedic contraindications for standing and walking
- orthopedic surgery in the past 6 months
- use of spasticity-reducing medication or Botox injections in the past 6 months
Data sourced from ClinicalTrials.gov (NCT02424526). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.