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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:
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT00467207
First received: April 27, 2007
Last updated: June 2, 2008
Last verified: April 2007
History of Changes
  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: Strength training
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Olavs Hospital:

Estimated Enrollment: 20
Study Start Date: September 2006
Study Completion Date: March 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467207

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

No publications provided

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: June 2, 2008
Health Authority: Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins, Type A
Botulinum Toxins
 Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013