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

Cerebral Palsy Clinical Trial

Official title:

Physical Therapy With Versus Without Strength Training After Botulinum-toxin Treatment in Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552721
• Other study ID #: KF 02 323948
• Status: Completed
• Phase: N/A
• First received: October 31, 2007
• Last updated: September 4, 2009
• Start date: October 2007
• Est. completion date: July 2009

Study information

• Verified date: September 2009
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 18 Years

Eligibility

Inclusion Criteria:

• cerebral palsy (diplegia and hemiplegia)

• indication for anti-spastic treatment with Botulinum toxin

Exclusion Criteria:

• fixed contractures

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.
• Physical therapy without strength training
12 weeks of physical therapy after Botulinum-toxin treatment (two 45-min sessions/week) without strength training.

Locations

Country	Name	City	State
Denmark	Gait Analysis Laboratory, Department of Orthopedic Surgery, Hvidovre University Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Three-dimensional gait analysis		12 weeks
Primary	Selective motor control		12 weeks
Secondary	Spasticity (modified Ashworth)		12 weeks
Secondary	Range of motion		12 weeks