Back to resultsPhysical Therapy After Anti-spastic Treatment in Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Physical therapy with strength training
Physical therapy without strength training
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Motor control, Spasticity
Eligibility Criteria
Inclusion Criteria:
- cerebral palsy (diplegia and hemiplegia)
- indication for anti-spastic treatment with Botulinum toxin
Exclusion Criteria:
- fixed contractures
Sites / Locations
- Gait Analysis Laboratory, Department of Orthopedic Surgery, Hvidovre University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Physical therapy with strength training.
Physical therapy without strength training.
Outcomes
Primary Outcome Measures
Three-dimensional gait analysis
Selective motor control
Secondary Outcome Measures
Spasticity (modified Ashworth)
Range of motion
Full Information
NCT ID
NCT00552721
First Posted
October 31, 2007
Last Updated
September 4, 2009
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00552721
Brief Title
Physical Therapy After Anti-spastic Treatment in Children With Cerebral Palsy
Official Title
Physical Therapy With Versus Without Strength Training After Botulinum-toxin Treatment in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Motor control, Spasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Physical therapy with strength training.
Arm Title
B
Arm Type
Active Comparator
Arm Description
Physical therapy without strength training.
Intervention Type
Other
Intervention Name(s)
Physical therapy with strength training
Intervention Description
12 weeks of physical therapy after Botulinum-toxin treatment (two 45-min sessions/week) with an emphasis on strength training.
Intervention Type
Other
Intervention Name(s)
Physical therapy without strength training
Intervention Description
12 weeks of physical therapy after Botulinum-toxin treatment (two 45-min sessions/week) without strength training.
Primary Outcome Measure Information:
Title
Three-dimensional gait analysis
Time Frame
12 weeks
Title
Selective motor control
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Spasticity (modified Ashworth)
Time Frame
12 weeks
Title
Range of motion
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
cerebral palsy (diplegia and hemiplegia)
indication for anti-spastic treatment with Botulinum toxin
Exclusion Criteria:
fixed contractures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Bandholm, MSc
Organizational Affiliation
Gait Analysis Laboratory, Department of Orthopedic Surgery, Hvidovre University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stig Sonne-Holm, MD, DSc
Organizational Affiliation
Gait Analysis Laboratory, Department of Orthopedic Surgery, Hvidovre University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bente R Jensen, PhD
Organizational Affiliation
Institute of Exercise and Sport Sciences, University of Copenhagen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Søren A Pedersen, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Gait Analysis Laboratory, Department of Orthopedic Surgery, Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
DK-2650
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Physical Therapy After Anti-spastic Treatment in Children With Cerebral Palsy
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