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

NCT ID: NCT00552721

Last Updated: 2009-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-07-31

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A

Physical therapy with strength training.

Group Type: EXPERIMENTAL

Physical therapy with strength training

Intervention Type: OTHER

12 weeks of physical therapy after Botulinum-toxin treatment (two 45-min sessions/week) with an emphasis on strength training.

B

Physical therapy without strength training.

Group Type: ACTIVE_COMPARATOR

Physical therapy without strength training

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Physical therapy without strength training

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• cerebral palsy (diplegia and hemiplegia)
• indication for anti-spastic treatment with Botulinum toxin

Exclusion Criteria

• fixed contractures

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Thomas Bandholm, MSc

Role: PRINCIPAL_INVESTIGATOR

Gait Analysis Laboratory, Department of Orthopedic Surgery, Hvidovre University Hospital

Stig Sonne-Holm, MD, DSc

Role: STUDY_CHAIR

Gait Analysis Laboratory, Department of Orthopedic Surgery, Hvidovre University Hospital

Bente R Jensen, PhD

Role: STUDY_CHAIR

Institute of Exercise and Sport Sciences, University of Copenhagen

Søren A Pedersen, MD

Role: STUDY_CHAIR

Hvidovre University Hospital

Locations

Gait Analysis Laboratory, Department of Orthopedic Surgery, Hvidovre University Hospital

Hvidovre, , Denmark

Countries

Denmark

Other Identifiers

KF 02 323948

Identifier Type: -

Identifier Source: org_study_id