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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Botulinum Toxin A
Resistance training
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

BoNT A

Resistance training

Arm Description

Botulinum toxin A injections in muscles of the arm (biceps brachii and brachialis)

8 weeks resistance training

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 27, 2007
Last Updated
April 15, 2016
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT00467207
Brief Title
Intensive Strength Training in Children With Cerebral Palsy - Effect on Hand Function
Official Title
Intensive Strength Training in Children With Cerebral Palsy - Effect on Hand Function
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BoNT A
Arm Type
Active Comparator
Arm Description
Botulinum toxin A injections in muscles of the arm (biceps brachii and brachialis)
Arm Title
Resistance training
Arm Type
Experimental
Arm Description
8 weeks resistance training
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin A
Other Intervention Name(s)
Botox, BoNT A
Intervention Type
Behavioral
Intervention Name(s)
Resistance training
Other Intervention Name(s)
Strength training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torarin I Lamvik, md
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Karin Roeleveld, phd
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Olavs Hospital
City
Trondheim
ZIP/Postal Code
7004
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22747635
Citation
Elvrum AK, Braendvik SM, Saether R, Lamvik T, Vereijken B, Roeleveld K. Effectiveness of resistance training in combination with botulinum toxin-A on hand and arm use in children with cerebral palsy: a pre-post intervention study. BMC Pediatr. 2012 Jul 2;12:91. doi: 10.1186/1471-2431-12-91.
Results Reference
result
PubMed Identifier
19811515
Citation
Braendvik SM, Elvrum AK, Vereijken B, Roeleveld K. Relationship between neuromuscular body functions and upper extremity activity in children with cerebral palsy. Dev Med Child Neurol. 2010 Feb;52(2):e29-34. doi: 10.1111/j.1469-8749.2009.03490.x. Epub 2009 Oct 7.
Results Reference
result
PubMed Identifier
22071153
Citation
Braendvik SM, Roeleveld K. The role of co-activation in strength and force modulation in the elbow of children with unilateral cerebral palsy. J Electromyogr Kinesiol. 2012 Feb;22(1):137-44. doi: 10.1016/j.jelekin.2011.10.002. Epub 2011 Nov 8.
Results Reference
result

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

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