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

April 15, 2016 updated by: St. Olavs Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7004
        • St. Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Behavioral: Resistance training
Other Names:
  • Strength training
Drug: Botulinum Toxin A
Other Names:
  • Botox
  • BoNT A

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Olavs Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

April 27, 2007

First Submitted That Met QC Criteria

April 27, 2007

First Posted (Estimate)

April 30, 2007

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06/1553

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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