N/A
N=43
Power Training Combined With Interval Treadmill Training
Cerebral Palsy · Central Nervous System Diseases · Brain Damage, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT03625570 ↗Enrolled (actual)
43
Serious AEs
2.3%
Results posted
Dec 2024
Primary outcome: Primary: Change in Self-selected Gait Speed (Normalized) — -0.0010; 0.0163 dimensionless
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Power training combined with interval treadmill training (Behavioral); Strength training combined with traditional treadmill training (Behavioral)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Self-selected Gait Speed (Normalized) |
0.0156; 0.0144 | — |
| PRIMARY Change in Fast Gait Speed (Normalized) |
0.0528; 0.0226 | — |
| PRIMARY Change in Peak Power |
57.9248; 1.5342 | — |
| PRIMARY Change in Average Strides Per Day |
-139.77; -299.82 | — |
| SECONDARY Change in Self-selected Gait Speed (Normalized) |
0.0156; 0.0144 | — |
| SECONDARY Change in Fast Gait Speed (Normalized) |
0.0528; 0.0226 | — |
| SECONDARY Change in Peak Power |
57.9248; 1.5342 | — |
| SECONDARY Change in Average Strides Per Day |
-139.77; -299.82 | — |
| SECONDARY Change in One Minute Walk Test |
8.349; 7.750 | — |
| SECONDARY Change in Cross-sectional Area |
0.3390; 0.2692 | — |
| SECONDARY Change in Isokinetic Muscle Strength of Knee Extensors |
3.8778; 2.1524 | — |
| SECONDARY Change in Walking Intensity at Medium and High Stride Rates (Strides/Minute) |
0.01313; -0.06635 | — |
| SECONDARY Change in Patient-Reported Outcomes Measurement Information System Physical Function-Mobility (PROMIS v2.0 Pediatric Profile 49 - Physical Function-Mobility) |
2.229; 2.792 | — |
| SECONDARY Change in 1RM (Muscle Strength) |
54.568; 49.961 | — |
Summary
Ambulatory children with cerebral palsy (CP) experience walking limitations which negatively influence their ability to physically participate in day to day life. The investigators propose that impaired muscle power generation is the key limiting factor affecting walking activity and participation. This proposal represents a combined approach where participants undergo resistance training for muscle power generation in combination with locomotor treadmill training that is based on typical pediatric walking and activity patterns rather than adult protocols, which are endurance or time-based. Therefore, the primary objective of this randomized controlled trial is to determine the effect of lower extremity Power Training combined with interval Treadmill Training (PT³) on functional walking capacity and community-based activity and participation in children with CP. We hypothesize that remediating the most pronounced muscle performance impairment (i.e., muscle power) with power training combined with a task- specific approach to walking that is developmentally appropriate will have a significant effect on walking capacity and performance.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of bilateral spastic Cerebral Palsy (CP)
- Age 10 to 17 years inclusive
- GMFCS levels I, II, or III
Exclusion Criteria
- Orthopedic or neurosurgery less than 12 months prior to enrollment
- Injection therapies (phenol, botulinum toxin) less than 3 months prior to enrollment
- Lacking greater than 25 degrees of knee extension
Data sourced from ClinicalTrials.gov (NCT03625570). 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.