Effect of Botulinum Toxin Type A Associated With Physical Therapy on Children With Spastic Cerebral Palsy

Physical Therapy Clinical Trial

Official title:

Effect of Botulinum Toxin Type A Associated With Physical Therapy on the Functional Capacity of Children With Spastic Cerebral Palsy: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03704155
• Other study ID #: BTA
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Botulinum Toxin
• Cerebral Palsy
• Cerebral Palsy, Spastic
• Muscle Spasticity
• Physical Therapy

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