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

NCT04940143 | Unknown

• 1 other identifier: 09.2020.863
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Hemiplegic Cerebral Palsy

Keywords

Botulinum toxin; Hemiplegic cerebral palsy; Postural control; Sensory function; Balance

Outcome Measures

Primary Outcomes (6)

• Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) of NeuroCom Balance Master

  Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) will be done by Balance Master device. Postural sway velocities (degree/second) will be recorded on the firm and foam surfaces with eyes opened and closed conditions of mCTSIB test. Higher scores mean worse static postural stability.

  before intervention (T0)

• Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) test of NeuroCom Balance Master

  Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) test will be done by Balance Master device. Postural sway velocities (degree/second) will be recorded on the firm and foam surfaces with eyes opened and closed conditions of mCTSIB test. Higher scores mean worse static postural stability.

  4th week after intervention (T1)

• Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) test of NeuroCom Balance Master

  Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) test will be done by Balance Master device. Postural sway velocities (degree/second) will be recorded on the firm and foam surfaces with eyes opened and closed conditions of mCTSIB test. Higher scores mean worse static postural stability.

  3rd month after intervention (T2)

• Light touch pressure treshold

  Light touch pressure (tactile) sensation will be assessed by using Semmes-Weinstein Monofilaments kit (Baseline, White Plains, New York, NY,USA) at the first and fifth metatarsal heads and heel of the plantar side of each foot. The light touch pressure threshold will be defined as the thinner monofilament value the participant correctly identified twice out of three trials for each application site. Higher scores mean worse tactile sensation.

  before intervention (T0)

• Light touch pressure treshold

  Light touch pressure (tactile) sensation will be assessed by using Semmes-Weinstein Monofilaments kit (Baseline, White Plains, New York, NY,USA) at the first and fifth metatarsal heads and heel of the plantar side of each foot. The light touch pressure threshold will be defined as the thinner monofilament value the participant correctly identified twice out of three trials for each application site. Higher scores mean worse tactile sensation.

  4th week after intervention (T1)

• Light touch pressure treshold

  Light touch pressure (tactile) sensation will be assessed by using Semmes-Weinstein Monofilaments kit (Baseline, White Plains, New York, NY,USA) at the first and fifth metatarsal heads and heel of the plantar side of each foot. The light touch pressure threshold will be defined as the thinner monofilament value the participant correctly identified twice out of three trials for each application site. Higher scores mean worse tactile sensation.

  3rd month after intervention (T2)

Secondary Outcomes (21)

• Modified Ashworth Scale (MAS)

  before intervention (T0)

• Modified Ashworth Scale (MAS)

  4th week after intervention (T1)

• Modified Ashworth Scale (MAS)

  3rd month after intervention (T2)

• Modified Tardieu Scale (MTS)

  before intervention (T0)

• Modified Tardieu Scale (MTS)

  4th week after intervention (T1)

Study Arms (1)

Botulinum toxin-A

EXPERIMENTAL

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.

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

Interventions

Botulinum toxin type-A (Onabotulinum toxin type-A) DRUG

Botulinum toxin-A (Onabotulinum toxin type-A/Botox®) injection will be administered from three different points, two on the medial head of the gastrocnemius muscle and one point on the lateral head with total 3-6 units/kg dose, under the guidance of electrical stimulation for the detection of the target neuromuscular junction.

Botulinum toxin-A

Physical Therapy OTHER

After the botulinum toxin-A injection, the patients will be included in the comprehensive physiotherapy program thrice a week for a total of 12 weeks. The physiotherapy program will be consisted of the ankle range of motion and stretching, strengthening of the antagonist muscles, proprioception exercises, functional walking training and static and dynamic balance training.

Botulinum toxin-A

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Visual, vestibular and cognitive deficits
• Presence of fixed contracture or joint instability in the affected ankle
• Severe scoliosis (Cobb angle \>40°)
• Uncontrolled epilepsy
• Having undergone selective dorsal rhizotomy

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Botulinum Toxins, Type A; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Therapeutics; Rehabilitation

Study Officials

• Evrim Karadag Saygi, Prof

  Marmara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sefa Kurt, MD

CONTACT

+905385159528; sefa.kurt@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 25, 2021
• Study Start: August 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: July 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)