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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Derek Curtis, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01357954
First received: May 6, 2011
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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 Intervention
Cerebral Palsy
Other: Regular physiotherapy
Other: Targeted Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Change from baseline in Gross Motor Function Measure at 6 months [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Pediatric Evaluation of Disability Inventory (PEDI)at 6 months [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in thickness of the erector spinae muscles measured with ultrasound at 6 months [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in seated sway at 6 months [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Degree of achievement of a goal set at baseline using a modified Goal Attainment Scale (GAS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in Pediatric Evaluation of Disability Inventory (PEDI)at 12 months [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in thickness of the erector spinae muscles measured with ultrasound at 12 months [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in seated sway at 12 months [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
  • Degree of achievement of a goal set at baseline using a modified Goal Attainment Scale (GAS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in Gross Motor Function Measure at 12 months [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Targeted Training Other: Targeted Training
Targeted training, 5 days a week for 6 months, up to 30 minutes a day
Other Names:
  • Targeted Training
  • The Movement Centre
Control Other: Regular physiotherapy
The child's regular physiotherapy
Other Name: Physiotherapy

  Eligibility

Ages Eligible for Study:   2 Years to 15 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 6, 2011
Last Updated: March 19, 2013
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

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

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014