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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03704155
Other study ID # BTA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date June 2018

Study information

Verified date October 2018
Source University of Nove de Julho
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Purpose: The aim of this study was investigate the effects of botulinum toxin type A (BoNT-A) associated with physical therapy on the functional capacity of children with spastic cerebral palsy (CP). Material and methods: Twenty-four children with spastic CP were concealed and randomly assigned to the Experimental Group (EG) consisting of 12 patients treated with BoNT-A and physical therapy and Control with 12 patients treated only with physical therapy. All participants were assessed through motor and functional scales (GMFM-88, Ashworth, Berg Balance Scale, TUG test and Pediatric Evaluation of Disability Inventory) at three different times: before and after 30 days of treatment as well as 3 months after the end of treatment.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date June 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 5 Years to 12 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of spastic Cerebral Palsy

- Clinical diagnosis of Dynamic equine feet

Exclusion Criteria:

- Use of phenol in the last 12 months

- Neurological blocks in the last 6 months

- Clinical diagnosis of structured orthopedic deformities with surgical indications

Study Design


Intervention

Drug:
Botulinum toxin type A
Botulinum Toxin type A The intervention with BoNT-A (Dysport®, Ipsen Biopharmaceutical, USA) was performed in the gastrocnemius and soleus muscles, bilaterally for diplegic children and unilaterally for hemiplegic children.
Other:
Physical Therapy
Physiotherapeutic intervention was performed twice a week, with duration of one hour per session for 4 weeks. To maintain standardization of treatment, physiotherapists received a booklet with instructions on what treatment they should do. The intervention protocol consisted of: Passive stretching of lower limbs, Stretching associated with the functionality of the plantar flexor muscles, knee flexors, adductors and hip flexors; Strengthening of the antagonist muscles with the application of BoNT-A; Static and dynamic balance training; Up and down stairs; Functional walking training, prioritizing the initial contact of the heel and active and passive dorsiflexion.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
University of Nove de Julho Claudia Santos Oliveira, Daniela Aparecida Biasotto-Gonzalez

Outcome

Type Measure Description Time frame Safety issue
Primary Severity of muscle hypertonia The classification of hypertonia was performed by Modified Ashworth Scale 3 months
Primary Functional balance Functional balance was assessed using the Berg Balance Scale (BBS). 3 months
Secondary Functional mobility Functional mobility was performed by The Timed Up and Go test (TUG test). 3 months
Secondary Functional performance Functional performance was assessed using Pediatric Evaluation of Disability Inventory (PEDI). 3 months
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