Effects of Botulinum Toxin Injection on Sensation and Postural Control in Children With Hemiplegic Cerebral Palsy

Marmara University

Status: Unknown

Conditions: Cerebral Palsy; Hemiplegic Cerebral Palsy

Treatments: Drug: Botulinum toxin type-A (Onabotulinum toxin type-A); Other: Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04940143

09.2020.863

Details and patient eligibility

About

In this study, the investigators aimed to investigate the effects of botulinum neurotoxin type A (BoNT-A) injection applied to the ankle plantar flexor muscles on lower extremity sensation and quantitative balance parameters in children with spastic hemiplegic cerebral palsy who are ambulatory without an assistive device in daily life.

Full description

Cerebral palsy (CP) refers to a group of movement and posture disorders that limit activity and participation, that are attributed to non-progressive disturbances in the developing fetus or infant brain. One of the main clinical findings of CP is postural control disorder. Many concomitant impairments such as joint range of motion limitations, spasticity, contractures, sensory deficits and loss of selective motor control contribute to postural control disorder.

One of the most common causes of motor dysfunction in children with CP is the presence of spasticity. Spasticity in the ankle plantar flexor muscles and weakness in the dorsiflexor muscles are the main factors that cause gait disturbance. Thus, impairments in gait function cause limitation of postural stability. Although there are many methods in spasticity management, BoNT-A injections have been used effectively and safely for many years, especially in reducing ankle plantar flexor spasticity. There are limited number of studies in the literature investigating the effect of BoNT-A injection on postural control in children with spastic CP, and only one study included children with spastic hemiplegic (unilateral) CP and it was clearly highlighted that new studies are needed in this area.

The reclassification of CP acknowledges the contribution of impaired sensation in motor performance. Although it has been shown that somatosensory deficits in the lower extremities of children with spastic CP can negatively affect gait and balance, the effect of spasticity in the ankle has not been evaluated.

In this study, the investigators aimed to investigate the effects of BoNT injection applied to the ankle plantar flexor muscles on lower extremity sensation and quantitative balance parameters in children with spastic hemiplegic CP who are ambulatory without an assistive device in daily life.

Enrollment: 19 estimated patients

Sex: All

Ages: 5 to 13 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients diagnosed with hemiplegic cerebral palsy
• Age between 5-13 years
• MAS ≥ 2 spasticity in the affected ankle
• Gross Motor Function Classification System (GMFCS) level I-II
• Able to understand given commands
• Sufficient cooperation to understand instructions and participate evaluations
• Giving an informed consent
• Botulinum toxin A injection decision made by an experienced Physiatrist

Exclusion criteria

• Visual, vestibular and cognitive deficits
• Botulinum toxin A treatment within 6 months or having undergone an orthopaedic surgery 1 year prior to inclusion in the study
• Presence of fixed contracture or joint instability in the affected ankle
• Severe scoliosis (Cobb angle >40°)
• Uncontrolled epilepsy
• Having undergone selective dorsal rhizotomy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

19 participants in 1 patient group

Botulinum toxin-A

Experimental group

Description:

Botulinum toxin-A (Onabotulinum toxin type-A) injection with electrical stimulation guidance will be administered to spastic ankle plantar flexor muscles. After the injection, the patients will be included in the comprehensive physiotherapy program.

Treatment:

Drug: Botulinum toxin type-A (Onabotulinum toxin type-A)

Other: Physical Therapy