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Clinical Trials/NCT01357954
NCT01357954CompletedNot Applicable

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

Hvidovre University Hospital1 site in 1 country28 target enrollmentStarted: June 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
28
Locations
1
Primary Endpoint
Change from baseline in Gross Motor Function Measure at 6 months

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
2 Years to 15 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Targeted Training

Experimental

Intervention: Targeted Training (Other)

Control

Other

Intervention: Regular physiotherapy (Other)

Outcomes

Primary Outcomes

Change from baseline in Gross Motor Function Measure at 6 months

Time Frame: Baseline, 6 months

Secondary Outcomes

  • Change from baseline in seated sway at 12 months(Baseline, 12 months)
  • 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 thickness of the erector spinae muscles measured with ultrasound at 12 months(Baseline, 12 months)
  • Degree of achievement of a goal set at baseline using a modified Goal Attainment Scale (GAS)(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Derek Curtis

Research Physiotherapist, Hvidovre University Hospital.

Hvidovre University Hospital

Study Sites (1)

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