Physical Therapy After Anti-spastic Treatment in Children With Cerebral Palsy

This study has been completed.
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00552721
First received: October 31, 2007
Last updated: September 4, 2009
Last verified: September 2009
  Purpose

It is the primary purpose of this pilot study to investigate if physical therapy with strength training is better at improving muscle and gait function after anti-spastic treatment with Botulinum toxin compared to physical therapy without strength training in children with cerebral palsy. The investigators hypothesize that it is.


Condition Intervention
Cerebral Palsy
Other: Physical therapy with strength training
Other: Physical therapy without strength training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physical Therapy With Versus Without Strength Training After Botulinum-toxin Treatment in Children With Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Three-dimensional gait analysis [ Time Frame: 12 weeks ]
  • Selective motor control [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Spasticity (modified Ashworth) [ Time Frame: 12 weeks ]
  • Range of motion [ Time Frame: 12 weeks ]

Enrollment: 14
Study Start Date: October 2007
Study Completion Date: July 2009
Arms Assigned Interventions
Experimental: A
Physical therapy with strength training.
Other: Physical therapy with strength training
12 weeks of physical therapy after Botulinum-toxin treatment (two 45-min sessions/week) with an emphasis on strength training.
Active Comparator: B
Physical therapy without strength training.
Other: Physical therapy without strength training
12 weeks of physical therapy after Botulinum-toxin treatment (two 45-min sessions/week) without strength training.

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cerebral palsy (diplegia and hemiplegia)
  • indication for anti-spastic treatment with Botulinum toxin

Exclusion Criteria:

  • fixed contractures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552721

Locations
Denmark
Gait Analysis Laboratory, Department of Orthopedic Surgery, Hvidovre University Hospital
Hvidovre, Denmark, DK-2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Thomas Bandholm, MSc Gait Analysis Laboratory, Department of Orthopedic Surgery, Hvidovre University Hospital
Study Chair: Stig Sonne-Holm, MD, DSc Gait Analysis Laboratory, Department of Orthopedic Surgery, Hvidovre University Hospital
Study Chair: Bente R Jensen, PhD Institute of Exercise and Sport Sciences, University of Copenhagen
Study Chair: Søren A Pedersen, MD Department of Pediatrics, Hvidovre University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00552721     History of Changes
Other Study ID Numbers: KF 02 323948
Study First Received: October 31, 2007
Last Updated: September 4, 2009
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
Motor control
Spasticity

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014