Clinical trial NCT04940143: Effects of Botulinum Toxin Injection on Sensation and Postural Control in Children With Hemiplegic Cerebral Palsy
Official title: The Evaluation of Effects of Botulinum Toxin Injection on Lower Extremity Somatosensory Impairment and Postural Control in Children With Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Hemiplegic Cerebral Palsy
Keywords: Botulinum toxin
Hemiplegic cerebral palsy
Postural control
Sensory function
Balance
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 19
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) of NeuroCom Balance Master
timeFrame: before intervention (T0)
measure: Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) test of NeuroCom Balance Master
timeFrame: 4th week after intervention (T1)
measure: Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) test of NeuroCom Balance Master
timeFrame: 3rd month after intervention (T2)
measure: Light touch pressure treshold
timeFrame: before intervention (T0)
measure: Light touch pressure treshold
timeFrame: 4th week after intervention (T1)
measure: Light touch pressure treshold
timeFrame: 3rd month after intervention (T2)
Secondary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: before intervention (T0)
measure: Modified Ashworth Scale (MAS)
timeFrame: 4th week after intervention (T1)
measure: Modified Ashworth Scale (MAS)
timeFrame: 3rd month after intervention (T2)
measure: Modified Tardieu Scale (MTS)
timeFrame: before intervention (T0)
measure: Modified Tardieu Scale (MTS)
timeFrame: 4th week after intervention (T1)
measure: Modified Tardieu Scale (MTS)
timeFrame: 3rd month after intervention (T2)
measure: Sit to Stand (STS) test of Neurocom Balance Master
timeFrame: before intervention (T0)
measure: Sit to Stand (STS) test of Neurocom Balance Master
timeFrame: 4th week after intervention (T1)
measure: Sit to Stand (STS) test of Neurocom Balance Master
timeFrame: 3rd month after intervention (T2)
measure: Step&Quick Turn (SQT) test of Neurocom Balance Master
timeFrame: before intervention (T0)
measure: Step&Quick Turn (SQT) test of Neurocom Balance Master
timeFrame: 4th week after intervention (T1)
measure: Step&Quick Turn (SQT) test of Neurocom Balance Master
timeFrame: 3rd month after intervention (T2)
measure: Two-point discrimination
timeFrame: before intervention (T0)
measure: Two-point discrimination
timeFrame: 4th week after intervention (T1)
measure: Two-point discrimination
timeFrame: 3rd month after intervention (T2)
measure: Selective Control Assessment of the Lower Extremity (SCALE)
timeFrame: before intervention (T0)
measure: Selective Control Assessment of the Lower Extremity (SCALE)
timeFrame: 4th week after intervention (T1)
measure: Selective Control Assessment of the Lower Extremity (SCALE)
timeFrame: 3rd month after intervention (T2)
measure: Timed Up and Go (TUG) test
timeFrame: before intervention (T0)
measure: Timed Up and Go (TUG) test
timeFrame: 4th week after intervention (T1)
measure: Timed Up and Go (TUG) test
timeFrame: 3rd month after intervention (T2)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Marmara University
name: Evrim Karadag Saygi, Prof
role: PRINCIPAL_INVESTIGATOR
References: