Neuromuscular Mechanisms of Specific Trunk Interventions in Children With CP
ConditionChild Behavior
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-12
SponsorShirley Ryan AbilityLab
About this trial
Determine the effect of repeated pelvis perturbation training on trunk posture and locomotor function in children with CP.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children with a diagnosis of bilateral spastic CP attributed to complications of prematurity, intracranial hemorrhage and periventricular leukmalacia according to the definition of Bax.
Children aged 4 to 12 years old without Botulinum toxin treatment within 6 months, and without surgeries (such as selective dorsal rhizotomy) within 12 months before the onset of the training.
Subjects will be able to remain seated without help for ≥10s.
GMFCS levels will be I to IV.
Disqualifiers
severe lower extremity contractures, fractures, osseous instabilities, osteoporosis.
severe disproportional bone growth.
unhealed skin lesions in the lower extremities.
thromboembolic diseases, cardiovascular instability.
Trial design
Design model
Parallel
Treatments tested in this trial
robotic hippotherapy
BehavioralA custom designed cable-driven robotic system that mimics horseback movement during walking was used in this study.
Conventional physical therapy
BehavioralStretching of trunk and leg muscles, followed by sitting and standing balance training, and conventional treadmill walking.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Robotic hippotherapyExperimental treatment 1 intervention
Group B: Conventional physical therapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Trunk Control Measurement Scale (TCMS) score from baseline.
The maximum value for the total TCMS is 58 points (no unit). Specifically, there is 20 points for the category 'static sitting balance', 28 points for 'selective movement control', and 10 points for 'dynamic reaching'). A higher TCMS scores indicates a better motor performance in trunk control.
Time frame
baseline, post 6 weeks of training and 8 weeks after the end of training.Secondary outcomes
1
Change in Walking speed from baseline
Overground walking speed
Time frame
baseline, post 6 weeks of training and 8 weeks after the end of training.2
Chang in 6-minute walking distance from baseline
Walking distance within 6 minutes
Time frame
baseline, post 6 weeks of training and 8 weeks after the end of training.3
Change in GMFM-66
Gross Motor Function Measure
Time frame
baseline, post 6 weeks of training and 8 weeks after the end of training.Sponsors and contacts
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Source ClinicalTrials.gov