N/A N=19 Other

Muscle Synergies During Gait in Children With Cerebral Palsy Undergoing Robot-assisted Gait Therapy

Cerebral Palsy

Bottom Line

View on ClinicalTrials.gov: NCT06156969 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2024

Primary outcome: Primary: Change in Cosine Similarity of the Muscle Synergies of the Most Affected Lower Limb — 2 percentage of muscle synergies

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Robot-Assisted Gait Training (Device)
Age: Pediatric, Adult · 6+ yrs
Sex: All
Sponsor: Spaulding Rehabilitation Hospital
Primary completion: Sep 2018

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	—

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.

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

View full record on ClinicalTrials.gov →

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.