Clinical trial NCT01357954: The Efficacy of Targeted Training on the Postural Control and Gross Motor Function in Children With Cerebral Palsy
Official title: The Efficacy of Targeted Training on the Postural Control and Gross Motor Function in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Postural control
Targeted Training
Gross motor function
Cerebral palsy
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2011-05-23
Enrollment: 28
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Gross Motor Function Measure at 6 months
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change from baseline in Pediatric Evaluation of Disability Inventory (PEDI)at 6 months
timeFrame: Baseline, 6 months
measure: Change from baseline in thickness of the erector spinae muscles measured with ultrasound at 6 months
timeFrame: Baseline, 6 months
measure: Change from baseline in seated sway at 6 months
timeFrame: Baseline, 6 months
measure: Degree of achievement of a goal set at baseline using a modified Goal Attainment Scale (GAS)
timeFrame: 6 months
measure: Change from baseline in Pediatric Evaluation of Disability Inventory (PEDI)at 12 months
timeFrame: Baseline, 12 months
measure: Change from baseline in thickness of the erector spinae muscles measured with ultrasound at 12 months
timeFrame: Baseline, 12 months
measure: Change from baseline in seated sway at 12 months
timeFrame: Baseline, 12 months
measure: Degree of achievement of a goal set at baseline using a modified Goal Attainment Scale (GAS)
timeFrame: 12 months
measure: Change from baseline in Gross Motor Function Measure at 12 months
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
state: Copenhagen
Study officials:
affiliation: Hvidovre University Hospital
name: Derek J Curtis, PT MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hvidovre University Hospital
name: Stig Sonne-Holm, Dr Med
role: STUDY_DIRECTOR
References: