The Efficacy of Targeted Training on the Postural Control and Gross Motor Function in Children With Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: Targeted Training; Other: Regular physiotherapy

• Registration Number: NCT01357954
• Lead Sponsor: Hvidovre University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-05-06
• Study First Submitted QC: 2011-05-19
• Study First Posted: 2011-05-23
• Primary Completion: 2012-05
• Study Completion: 2013-06
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Targeted Training	Targeted Training	-
Control	Regular physiotherapy	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Gross Motor Function Measure at 6 months	Baseline, 6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Copenhagen, Denmark