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

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ClinicalTrials.gov Identifier: NCT00552721
Recruitment Status : Completed
First Posted : November 2, 2007
Last Update Posted : September 7, 2009
Sponsor:
Information provided by:
Hvidovre University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Cerebral Palsy Other: Physical therapy with strength training Other: Physical therapy without strength training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
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
Study Start Date : October 2007
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



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

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


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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

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

ClinicalTrials.gov Identifier: NCT00552721     History of Changes
Other Study ID Numbers: KF 02 323948
First Posted: November 2, 2007    Key Record Dates
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