Intensive Strength Training in Children With Cerebral Palsy - Effect on Hand Function

This study has been completed.
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT00467207
First received: April 27, 2007
Last updated: April 15, 2016
Last verified: April 2016
  Purpose
The objective of this study is to gain more knowledge about the association between muscle weakness, spasticity and motor control in children with cerebral palsy, and its relationship to hand function.

Condition Intervention Phase
Cerebral Palsy
Drug: Botulinum Toxin A
Behavioral: Resistance training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensive Strength Training in Children With Cerebral Palsy - Effect on Hand Function

Resource links provided by NLM:


Further study details as provided by St. Olavs Hospital:

Enrollment: 10
Study Start Date: September 2006
Study Completion Date: March 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BoNT A
Botulinum toxin A injections in muscles of the arm (biceps brachii and brachialis)
Drug: Botulinum Toxin A
Other Names:
  • Botox
  • BoNT A
Experimental: Resistance training
8 weeks resistance training
Drug: Botulinum Toxin A
Other Names:
  • Botox
  • BoNT A
Behavioral: Resistance training
Other Name: Strength training

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed spastic hemiplegic or diplegic cerebral palsy, reduced handfunction.
  • Indication for treatment with Botulinum Toxin A
  • Score 3 on House Classification of Upper-Extremity Functional Use
  • Score 3 or better on Manual Ability Classification System

Exclusion Criteria:

  • surgery within the last two years
  • Treatment with Botulinum Toxin within the last six months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467207

Locations
Norway
St. Olavs Hospital
Trondheim, Norway, 7004
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
Study Chair: Torarin I Lamvik, md St. Olavs Hospital
Principal Investigator: Karin Roeleveld, phd Norwegian University of Science and Technology
  More Information

Publications:
Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT00467207     History of Changes
Other Study ID Numbers: 06/1553 
Study First Received: April 27, 2007
Last Updated: April 15, 2016
Health Authority: Norway: Norwegian Social Science Data Services
Individual Participant Data  
Plan to Share IPD: Undecided

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
Botulinum Toxins, Type A
AbobotulinumtoxinA
OnabotulinumtoxinA
IncobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 25, 2016