Cerebral palsy Nervous System Diseases Cerebral palsy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Informed consent as documented by signature (Appendix Informed Consent Form) 2. Diagnosis of cerebral palsy 3. Gross Motor Function Classification System (GMFCS) level I-III 4. Aged 7 to 18 years
Exclusion criteria
Exclusion criteria: 1. Surgery at the trunk or lower limb level within the last six months 2. Botulinum toxin injection in the trunk or lower limbs within the last three months 3. Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc) 4. Known or suspected non-compliance 5. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders etc of the participant 6. Participation in another study including intensive therapy of the lower limbs within the 30 days preceding and during the present study 7. Intensive gait therapy within the 30 days preceding and during the present study 8. Inpatient rehabilitation stay aimed at improving gait within the 30 days preceding and during the present study 9. Previous enrolment into the current study 10. Mental age < 7 years 11. Severe visual impairments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Daily life gait performance corresponding to the individual goals of each participant (e.g. improvement in gait symmetry) 2. Physical activity levels (i.e. amount of time spent walking and/or in moderate to intensive physical activity) Both measured using a 10h measurement of daily activity using inertial motion sensors, the Physilog(R) 4 sensors (GaitUp, Switzerland), at baseline (BL) (week 0), pre (BL + 4 weeks), post (BL + 8 weeks), follow-up (BL + 12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Gross motor capacity, measured using the Gross Motor Function Measure 66 (GMFM-66) at BL and post 2. Goal attainment, measured using Goal Attainment Scaling (GAS) at BL, post and follow-up 3. Time taken for donning and doffing of sensors, recorded in the CRF at all four time-points (baseline, pre, post, follow-up) 4. Sensor data analysis within the two weeks after the baseline measurement of each patient 5. Feasibility of using the Physilog® inertial sensors for treatment planning in an outpatient setting, assessed with a semi-structured interview with physiotherapists after the follow-up measurement | — |
Countries
Switzerland