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

NCT ID: NCT00467207

Last Updated: 2016-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BoNT A

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

Group Type ACTIVE_COMPARATOR

Botulinum Toxin A

Intervention Type DRUG

Resistance training

8 weeks resistance training

Group Type EXPERIMENTAL

Botulinum Toxin A

Intervention Type DRUG

Resistance training

Intervention Type BEHAVIORAL

Interventions

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Botulinum Toxin A

Intervention Type DRUG

Resistance training

Intervention Type BEHAVIORAL

Other Intervention Names

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Botox BoNT A Strength training

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Torarin I Lamvik, md

Role: STUDY_CHAIR

St. Olavs Hospital

Karin Roeleveld, phd

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

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St. Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 22747635 (View on PubMed)

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.

Reference Type RESULT
PMID: 19811515 (View on PubMed)

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.

Reference Type RESULT
PMID: 22071153 (View on PubMed)

Other Identifiers

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06/1553

Identifier Type: -

Identifier Source: org_study_id

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