Cerebral palsy Nervous System Diseases Cerebral palsy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children aged 11 to 18 years suffering from spastic diplegia 2. Gross Motor Function Classification System (GMFCS) levels I to IV 3. Maximum weight 75 kg 4. Anthropometric measures of lower limbs according to the exoskeleton of CPWalker 5. Capable of understanding the proposed exercises 6. Able to signal pain or discomfort
Exclusion criteria
Exclusion criteria: 1. Patients who experimented concomitant treatments 3-months prior study (e.g. orthopedic surgery or botulinum toxin) 2. Children with muscle-skeletal deformities or unhealed skin lesions in the lower limbs that could prevent the use of the exoskeleton 3. Patients with critical alterations of motor control as dystonia, choreoathetosis or ataxia 4. Aggressive or self-harming behaviors 5. Severe cognitive impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gait function is measured using 3D gait analysis at baseline, 8 and 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Gait-speed is measured using 10-meter walking test at baseline, 8 and 16 weeks 2. Global responses involved and endurance is measured using 6-minutes walking test at baseline, 8 and 16 weeks 3. Maximum isometric strength is measured using a hand-held dynamometer 4. Selective voluntary motor control is measured using the Selective Control Assessment of Lower Extremity (SCALE) at baseline, 8 and 16 weeks 5. The changes in gross motor function are measured using the Gross Motor Function Measure (GMFM-88) dimensions D (standing) and E (walking) at baseline, 8 and 16 weeks 6. Psychological influence of fear and pain is measured using a personal kinesiophobia assessment at baseline, 8 and 16 weeks 7. Users' satisfaction is measured using the Gillette Functional Assessment Questionnaire (FAQ) at baseline, 8 and 16 weeks | — |
Countries
Spain