NCT00552721

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2007

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

September 7, 2009

Status Verified

September 1, 2009

First QC Date

October 31, 2007

Last Update Submit

September 4, 2009

Conditions

Cerebral Palsy

Keywords

Motor controlSpasticity

Outcome Measures

Primary Outcomes (2)

  • Three-dimensional gait analysis

    12 weeks

  • Selective motor control

    12 weeks

Secondary Outcomes (2)

  • Spasticity (modified Ashworth)

    12 weeks

  • Range of motion

    12 weeks

Study Arms (2)

A

EXPERIMENTAL

Physical therapy with strength training.

Other: Physical therapy with strength training

B

ACTIVE COMPARATOR

Physical therapy without strength training.

Other: Physical therapy without strength training

Interventions

Physical therapy with strength trainingOTHER

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

A
Physical therapy without strength trainingOTHER

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

B

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • fixed contractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hvidovre, DK-2650, Denmark

Location

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Interventions

Physical Therapy ModalitiesResistance Training

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationExercise TherapyAftercareContinuity of Patient CarePatient CarePhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Thomas Bandholm, MSc

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

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 31, 2007

First Posted

November 2, 2007

Study Start

October 1, 2007

Study Completion

July 1, 2009

Last Updated

September 7, 2009

Record last verified: 2009-09

Locations

DK(1)