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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357954
• Other study ID #: HVH-DJC-1-2011
• Status: Completed
• Phase: N/A
• Start date: June 2010
• Est. completion date: June 2013

Study information

• Verified date: August 2020
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Other:
• Regular physiotherapy
The child's regular physiotherapy
• Targeted Training
Targeted training, 5 days a week for 6 months, up to 30 minutes a day

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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