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

August 3, 2020 updated by: Derek Curtis, Hvidovre University Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Hvidovre, Copenhagen, Denmark, DK-2650
        • Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Other: Regular physiotherapy
The child's regular physiotherapy
Other Names:
  • Physiotherapy
Experimental: Targeted Training
Other: Targeted Training
Targeted training, 5 days a week for 6 months, up to 30 minutes a day
Other Names:
  • The Movement Centre

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Gross Motor Function Measure at 6 months
Time Frame: Baseline, 6 months
Baseline, 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Investigators

  • Principal Investigator: Derek J Curtis, PT MSc, Hvidovre University Hospital
  • Study Director: Stig Sonne-Holm, Dr Med, Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

May 6, 2011

First Submitted That Met QC Criteria

May 19, 2011

First Posted (Estimate)

May 23, 2011

Study Record Updates

Last Update Posted (Actual)

August 5, 2020

Last Update Submitted That Met QC Criteria

August 3, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HVH-DJC-1-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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