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

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ClinicalTrials.gov Identifier: NCT01357954
Recruitment Status : Unknown
Verified March 2013 by Derek Curtis, Hvidovre University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 23, 2011
Last Update Posted : March 20, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Cerebral Palsy Other: Regular physiotherapy Other: Targeted Training

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : June 2010
Primary Completion Date : May 2012
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in Gross Motor Function Measure at 6 months [ Time Frame: Baseline, 6 months ]

Secondary Outcome Measures :
  1. Change from baseline in Pediatric Evaluation of Disability Inventory (PEDI)at 6 months [ Time Frame: Baseline, 6 months ]
  2. Change from baseline in thickness of the erector spinae muscles measured with ultrasound at 6 months [ Time Frame: Baseline, 6 months ]
  3. Change from baseline in seated sway at 6 months [ Time Frame: Baseline, 6 months ]
  4. Degree of achievement of a goal set at baseline using a modified Goal Attainment Scale (GAS) [ Time Frame: 6 months ]
  5. Change from baseline in Pediatric Evaluation of Disability Inventory (PEDI)at 12 months [ Time Frame: Baseline, 12 months ]
  6. Change from baseline in thickness of the erector spinae muscles measured with ultrasound at 12 months [ Time Frame: Baseline, 12 months ]
  7. Change from baseline in seated sway at 12 months [ Time Frame: Baseline, 12 months ]
  8. Degree of achievement of a goal set at baseline using a modified Goal Attainment Scale (GAS) [ Time Frame: 12 months ]
  9. Change from baseline in Gross Motor Function Measure at 12 months [ Time Frame: Baseline, 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357954


Locations
Denmark
Hvidovre University Hospital
Hvidovre, Copenhagen, Denmark, DK-2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Derek J Curtis, PT MSc Hvidovre University Hospital
Study Director: Stig Sonne-Holm, Dr Med Hvidovre University Hospital
More Information

Responsible Party: Derek Curtis, Research Physiotherapist, Hvidovre University Hospital., Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01357954     History of Changes
Other Study ID Numbers: HVH-DJC-1-2011
First Posted: May 23, 2011    Key Record Dates
Last Update Posted: March 20, 2013
Last Verified: March 2013

Keywords provided by Derek Curtis, Hvidovre University Hospital:
Postural control
Targeted Training
Gross motor function
Cerebral palsy

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases