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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00467207
Other study ID # 06/1553
Secondary ID
Status Completed
Phase Phase 2
First received April 27, 2007
Last updated April 15, 2016
Start date September 2006
Est. completion date March 2008

Study information

Verified date April 2016
Source St. Olavs Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Social Science Data Services
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date March 2008
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 17 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Botulinum Toxin A

Behavioral:
Resistance training


Locations

Country Name City State
Norway St. Olavs Hospital Trondheim

Sponsors (2)

Lead Sponsor Collaborator
St. Olavs Hospital Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (3)

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 200 — View 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. — View Citation

Elvrum AK, Brændvik SM, Sæther 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 — View Citation

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