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

NCT00467207 | Completed Phase 2

• 1 other identifier: 06/1553
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Study Arms (2)

BoNT A

ACTIVE COMPARATOR

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

Drug: Botulinum Toxin A

Resistance training

EXPERIMENTAL

8 weeks resistance training

Drug: Botulinum Toxin A; Behavioral: Resistance training

Interventions

Botulinum Toxin A DRUG

Also known as: Botox, BoNT A

BoNT A; Resistance training

Resistance training BEHAVIORAL

Also known as: Strength training

Resistance training

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• surgery within the last two years
• Treatment with Botulinum Toxin within the last six months

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St. Olavs Hospital

Trondheim, 7004, Norway

Location

Related Publications (3)

• 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.

  PMID: 22747635 RESULT

• 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.

  PMID: 19811515 RESULT

• 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.

  PMID: 22071153 RESULT

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Botulinum Toxins, Type A; incobotulinumtoxinA; Resistance Training

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Torarin I Lamvik, md

  St. Olavs Hospital

  STUDY CHAIR

• Karin Roeleveld, phd

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2007
• First Posted: April 30, 2007
• Study Start: September 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: March 1, 2008
• Last Updated: April 18, 2016

Record last verified: 2016-04

Locations

NO (1)