Improvement After Botulinum Toxin Injections to the Arms in Children With Cerebral Palsy

NCT00549471 | Terminated Phase 4

• 1 other identifier: 180907.ctil
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: (1) Treating upper limb hypertonia/spasticity with Botox®, in addition to reducing hypertonia/spasticity, will (a) improve global development, (b) improve function (passive \& active), (c) reduce carer burden and (d) improve quality of life. (2) Early treatment with Botox® will have a greater impact on the rate of global development when compared to late treatment.

Conditions

Cerebral Palsy

Keywords

children with cerebral palsy ages eight to eleven.

Outcome Measures

Primary Outcomes (1)

• Quality of life

  2 years

Secondary Outcomes (1)

• 1. Hypertonia 2. Impairment measures 3. Upper extremity function 4. Function and patient needs assessment

  2 years

Study Arms (2)

BG

EXPERIMENTAL

cooperative quadriplegic CP children ages 8-11 years, gross motor function level 4 with troublesome hypertonia that will respond to treatment. BG children will be given Botulinum Toxin A, as clinically required, in addition to an equivalent program of intensive therapy

Other: Botulinum Toxin A and physiotherapy

Control Group

NO INTERVENTION

control group: Twenty cooperative quadriplegic CP children ages 8-11 years, gross motor function level 4 with troublesome hypertonia that will respond to treatment.CG children will undergo a program of intensive therapy.

Other: physiotherapy

Interventions

physiotherapy OTHER

CG children will undergo a program of intensive physiotherapy

Control Group

Botulinum Toxin A and physiotherapy OTHER

BG children will be given Botox, as clinically required, in addition to an equivalent program of intensive therapy. Botox injection will be tailored according to the specific child. Generally injection site will include biceps and brachioradialis, while flexors of the wrist and digits will be injected according to abnormal postures during function. Maximal total dose will be 23 IU per kg.

BG

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• cooperative quadriplegic CP children
• gross motor function level 4
• troublesome hypertonia that will respond to treatment with Botox

You may not qualify if:

• cognitive impairment (IQ\<70)
• severe behavioural disorder

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Physical Therapy Modalities; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; 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

Study Officials

• Hilla Ben-Pazi, MD

  Shaare Zedek Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 24, 2007
• First Posted: October 25, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 21, 2011

Record last verified: 2011-04

Locations

IL (1)