N/A
Completed N=19
Muscle Synergies During Gait in Children With Cerebral Palsy Undergoing Robot-assisted Gait Therapy
Source: ClinicalTrials.gov NCT06156969 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Change in Cosine Similarity of the Muscle Synergies of the Most Affected Lower Limb — 2 percentage of muscle synergies
Summary
This is a single-arm longitudinal study for children with cerebral palsy with gait impairments that involves robot-assisted gait training (RGT) and includes pre and post-data collection visits. The study aims to evaluate changes in muscle synergies in children with Cerebral Palsy (CP) in response to RGT. Additionally, the study aims to investigate the relationship between muscle synergies and the clinical outcomes of RGT.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cosine Similarity of the Muscle Synergies of the Most Affected Lower Limb |
2 | — |
| SECONDARY Change in Gross Motor Function Measure (GMFM) Dimension D |
5.9 | — |
| SECONDARY Change in Gross Motor Function Measure (GMFM) Dimension E |
10.0 | — |
| SECONDARY Percent Change in 10-Meter Walk Test |
-0.8 | — |
| SECONDARY Percent Change in 6-Minutes Walk Test |
23.5 | — |
| SECONDARY Percent Change in Edinburgh Visual Gait Scores (EVGS) |
16.7 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of spastic cerebral palsy
- 6 to 18 years of age
- Gross Motor Function (GMFCS) Level I, II, III or IV
- Femoral length < size of robotic exoskeleton used for gait training (femur length between 210-350mm)
- Ability to communicate pain or discomfort
Exclusion Criteria
- Recent use of Lokomat within the last 3 months
- Contraindication to robotic-assisted gait training such us thromboembolic disease, progressive neurologic disorder, cardiovascular or pulmonary contraindications, aggressive behaviors, severe cognitive deficits, bone instabilities, fractures, osteoporosis)
- Skin ulcers in trunk or lower limbs
- Hip, knee, ankle arthrodesis
Data sourced from ClinicalTrials.gov (NCT06156969). 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. Informational only — not medical advice.