We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00552721
First Posted: November 2, 2007
Last Update Posted: September 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hvidovre University Hospital
  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 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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): 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 Hvidovre University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00552721     History of Changes
Other Study ID Numbers: KF 02 323948
First Submitted: October 31, 2007
First Posted: November 2, 2007
Last Update Posted: September 7, 2009
Last Verified: September 2009

Keywords provided by Hvidovre University Hospital:
Motor control
Spasticity

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs