A Pilot Study of the Effect of Botulinum Toxin Type a (Dysport®, Abobotulinum Toxin A) Injection on Changes in Musculotendinous Length and Dynamics of Hamstring Muscles During Gait in Children With Spastic Cerebral Palsy Walking With Excessive Knee Flexion

NCT02917967 | Completed

• 1 other identifier: 4-2016-0265
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This is a longitudinal, prospective, and open-label interventional study in a single center. We will investigate the effect of single injection in each patient. This study was designed to establish the clinical evidence for effect of botulinum toxin type a (Dysport, abobotulinum toxin A) injection on changes in musculotendinous length and dynamics of hamstring muscles during gait in children with spastic cerebral palsy walking with excessive knee flexion. Baseline data such as Modified Ashworth scale (MAS), Modified Tardieu scale (MTS), Gross Motor Function Measures (GMFM), and Gross Motor Function Classification System (GMFCS) level will be assessed. Gait analysis will be performed using a computerized gait analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the gait cycle. A trained investigator will place 14 reflective markers on the anterior and posterior superior iliac spine, the mid points of the lateral femur, the lateral knee joint axis, the midpoints of the lateral tibia, the lateral malleolus, and the dorsal foot between metatarsal heads 2 and 3. All subjects should walk barefoot at a self-selected speed along an 8-meter path with the markers in place and the motion will be captured with a 100-Hz sampling frequency. Force-plates (AMTI OR 6-5, Advanced Mechanical Technology, Newton, MA, USA) under the path will record ground reaction forces during the walking trials with a 1000-Hz sampling frequency, and joint moments will be expressed as internal moments to counter the ground reaction forces. Data collection will continue until the subject achieved at least 3 'clean' force-plate strikes. Kinematic and kinetic data from successful trials will be used for statistical analysis. Video recording will be done simultaneously from the front, rear, and side, with the 3D gait analysis.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (3)

• Changes in musculotendinous length of hamstrings

  Changes in musculotendinous length of hamstrings obtained from 3D motion analysis after a single BoNT-A injection during walking in children with spastic CP walking with excessive knee flexion

  pre-intervention (1 hour before intervention)

• Changes in musculotendinous length of hamstrings

  Changes in musculotendinous length of hamstrings obtained from 3D motion analysis after a single BoNT-A injection during walking in children with spastic CP walking with excessive knee flexion

  4 weeks after intervention

• Changes in musculotendinous length of hamstrings

  Changes in musculotendinous length of hamstrings obtained from 3D motion analysis after a single BoNT-A injection during walking in children with spastic CP walking with excessive knee flexion

  16 weeks after intervention

Study Arms (1)

BTX injection group

EXPERIMENTAL

Botulinum toxin injection group

Drug: Botulinum toxin injection

Interventions

Botulinum toxin injection DRUG

1. BoNT-A will be injected into two hamstring and/or gastrocnemius muscles under the guidance of ultrasonography or electrical stimulation. 2. Maximal total dose and dose regimen for each muscle would follow the recommendation of international consensus. A. Semitendinosus 5 to 7.5 units/kg of body weight B. Semimembranosus 5 to 7.5 units/kg of body weight C. Gastrocnemius 10 units/kg of body weight D. Maximal total dose per patient : unilateral injection 500 units, bilateral injection 1,000 units E. The dosage of two hamstring muscles will depend on the severity of spasticity and gait abnormalities of children with CP

BTX injection group

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children with CP over the age of 2 years
• The spasticity is thought to interfere motor learning or cause abnormal posture and movement patterns by "management algorithm" of international consensus.
• MAS ≥ 1+ at hamstrings
• Dynamic spasticity rather than fixed contracture: Difference between Xv1 and Xv3 is at least 15 degrees in MTS at hamstrings
• I to III levels of GMFCS

You may not qualify if:

• Children who received interventions such as chemical nerve block or casting within 6 months
• Children who had baclofen pump
• Children who experienced the adverse reactions from previous BoNT-A injections
• Children who have a mixed type of CP (Athetosis, dystonia) or other movement disorder (eg. ataxia)
• Children who are participating in other investigational study at the moment
• Children who are not suitable for this study according to the investigator's discretion

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

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: September 27, 2016
• First Posted: September 28, 2016
• Study Start: November 15, 2016
• Primary Completion: September 3, 2018
• Study Completion: September 3, 2018
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)