Overview

This trial is active, not recruiting.

Condition cerebral palsy
Treatments regular physiotherapy, targeted training
Sponsor Hvidovre University Hospital
Start date June 2010
End date May 2012
Trial size 28 participants
Trial identifier NCT01357954, HVH-DJC-1-2011

Summary

The project aims to test the effectiveness and explore the possibility of performing a novel therapeutic approach, targeting to increase strength and coordination around the trunk, giving a more active and functional seating and head control in those children with cerebral palsy (CP) who are wheelchair users. The project will also try to determine the muscle physiological effect of treatment using indirect measures of strength in the spinal musculature.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
targeted training Targeted Training
Targeted training, 5 days a week for 6 months, up to 30 minutes a day
(Other)
regular physiotherapy Physiotherapy
The child's regular physiotherapy

Primary Outcomes

Measure
Change from baseline in Gross Motor Function Measure at 6 months
time frame: Baseline, 6 months

Secondary Outcomes

Measure
Change from baseline in Pediatric Evaluation of Disability Inventory (PEDI)at 6 months
time frame: Baseline, 6 months
Change from baseline in thickness of the erector spinae muscles measured with ultrasound at 6 months
time frame: Baseline, 6 months
Change from baseline in seated sway at 6 months
time frame: Baseline, 6 months
Degree of achievement of a goal set at baseline using a modified Goal Attainment Scale (GAS)
time frame: 6 months
Change from baseline in Pediatric Evaluation of Disability Inventory (PEDI)at 12 months
time frame: Baseline, 12 months
Change from baseline in thickness of the erector spinae muscles measured with ultrasound at 12 months
time frame: Baseline, 12 months
Change from baseline in seated sway at 12 months
time frame: Baseline, 12 months
Degree of achievement of a goal set at baseline using a modified Goal Attainment Scale (GAS)
time frame: 12 months
Change from baseline in Gross Motor Function Measure at 12 months
time frame: Baseline, 12 months

Eligibility Criteria

Male or female participants from 2 years up to 15 years old.

Inclusion Criteria: - diagnosis of CP made ​​by a neuro-pediatric physician experienced in assessment and diagnosis of CP - GMFCS level III, IV and V, - the child cannot walk without assistance, - age 2-15 year, - no joint deformity or contracture around the "Targeted" joint - not a candidate for surgery or other medical treatment that affects motor skills while participating in the project - trunk control problems. Exclusion Criteria: - uncontrolled epilepsy - surgery within 12 months of the study start - Botulinum toxin within 2 months of study start - Lack of personnel resources to treat the child at their school/kindergarten

Additional Information

Principal investigator Derek J Curtis, PT MSc
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Hvidovre University Hospital.