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Completed

NCT Number: NCT01357954

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre University Hospital

Hvidovre, Copenhagen, DK-2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regular physiotherapy

Other

The child's regular physiotherapy

Other names: Physiotherapy

Targeted Training

Other

Targeted training, 5 days a week for 6 months, up to 30 minutes a day

Other names: The Movement Centre

Primary outcomes

  1. Change from baseline in Gross Motor Function Measure at 6 months

    Time frame: Baseline, 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
May 23, 2011
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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