Text Size

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
History of Changes
  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:

U.S. FDA Resources

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 May 23, 2013