Intensive Activities-based Locomotor Training Program in Children With Cerebral Palsy

Primary outcomes

1. Gross Motor Function Measure-66 (GMFM)

   Time frame: 6.5 months

   Gross Motor Function Measure-66: Items scored on 0-3 scale. Minimum value: 0. Maximum value: 99. Higher scores indicate better outcome.

2. Pediatric Neuromuscular Recovery Scale (PedsNRS)

   Time frame: 6.5 months

   Pediatric Neuromuscular Recovery Scale: Each of the 13 items on the Peds NRS have 12 phases. Each item is scored on a 12-point scale, with one point allocated to each phase of the item. The age-appropriate item cards instruct the rater to begin at a designated "start phase" indicated by a bold box around the phase within the 12 phases on each card. If the child cannot perform the movement as listed in the start phase (which may be midway through the card), the rater starts at the beginning of the item card and assesses the child's performance at the first phase for that item. The rater continues sequentially through the 12 phases on the card until the child is unable to perform a phase. The rater scores the highest phase achieved by the child and moves on to the next item card, through all 13 items. Items are then summed into a summary Peds NRS score using an algorithm.

3. Pediatric Evaluation of Disability Inventory (PEDI-CAT)

   Time frame: 6.5 months

   Pediatric Evaluation of Disability Inventory:

4. Pediatric Quality of Life Inventory CP Module (PedsQL-CP)

   Time frame: 6.5 months

   For each of the 4 domains, in addition to scaled scores, normative standard scores (provided as T-scores and age percentiles) are calculated. Normative scores describe the child's performance in comparison to other children of the same age (in one year intervals). For T-scores, the mean for each age group is 50, with a standard deviation of 10 (same format used for normative scores in the original PEDI). Typically, T-scores between 30 and 70 (i.e. mean ± 2 standard deviations) are considered within the expected range for age. Scores below 30 indicate decreased functional ability compared to what is typically expected for that age range. Scores above 70 indicate scores above what is typically expected for that age range. Higher scores indicate better outcome.

5. Functional near-infrared spectroscopy

   Time frame: 6.5 months

   Non-invasive, continuous wave functional near-infrared spectroscopy using an OctaMon+ (Artinis Medical Systems, Lieden, Netherlands) to identify metabolic changes and track oxygenation status.

6. Electromyography

   Time frame: 6.5 months

   Electrodes will measure voluntary (child is asked to perform a movement) and reflex activities (patellar reflex, achilles reflex, triceps reflex) of the dominant limbs.

7. ActiGraph sensors

   Time frame: 6.5 months

   Activity performance will be measured using ActiGraph accelerometers, which are motion sensors worn as a bracelet around the rist designed to detect movement when worn. They have excellent inter-instrument reliability (ICC = 0.98).