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

NCT ID: NCT03704155

Last Updated: 2018-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-06-30

Brief 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.

Conditions

Cerebral Palsy, Spastic; Physical Therapy; Botulinum Toxin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental group (EG)

The EG was treated with Botulinum toxin type A and physiotherapy (stretching, balancing training, functional walking training).

Group Type: EXPERIMENTAL

Botulinum toxin type A

Intervention Type: DRUG

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.

Physical Therapy

Intervention Type: OTHER

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.

Control group (CG)

GC was treated with physiotherapy (stretching, balancing training, functional walking training).

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Claudia Santos Oliveira

UNKNOWN

Sponsor Role: collaborator

Daniela Aparecida Biasotto-Gonzalez

UNKNOWN

Sponsor Role: collaborator

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Fabiano Politti

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

BTA

Identifier Type: -

Identifier Source: org_study_id