Can Gait Analysis and Ultrasound Detect a Change in Calf Musculature in Children With Cerebral Palsy?

NCT04290689 | Unknown

• 1 other identifier: RL1 777
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

ORLAU is a clinical department of the Robert Jones and Agnes Hunt Orthopaedic Hospital. We treat patients with a wide range of movement disorders affecting their walking or arm function. One of the most common gait issues we see is toe-walking, this is most prevalent in those patients with cerebral palsy (CP). Toe-walking in CP children arises mostly from problems in the calf muscle, we currently use gait analysis to help guide treatment management plans. Two standard interventions for such cases are serial casting and Botulinum Toxin-A injections. Using gait analysis we will be able to see changes to the gait pattern before and after the interventions, however, we want to obtain a whole clinical picture, using B-mode ultrasound, elastography and electromyography (EMG) we will be able to achieve this. These measurements will provide us with information about the muscle architecture and properties including activation. This will help us to determine the effects of the interventions. Elastography is a fairly new clinical technique that uses shear waves generated by the ultrasound probe to map the stiffness of a muscle. Stiffness of muscle is a good indication of myopathies. The additional examinations we want to carry out are all non-invasive, they will be carried out in two sessions, one before the intervention and one after. We will compare the data we collect from the children with CP to our normal database with ORLAU has ethical approval for. The final stage of this study will be to use the muscle parameters obtained by ultrasound to set parameters in a computer musculoskeletal model.

Conditions

Cerebral Palsy

Keywords

cerebral palsy; b-mode ultrasound; gait analysis; EMG; elastography; musculoskeletal modelling

Outcome Measures

Primary Outcomes (9)

• Are there gait (kinetic) differences pre and post intervention in toe walking cerebral palsy subjects?

  Kinetics (joint forces) will be measured (using gait analysis modality) pre and post intervention in toe walking cerebral palsy subjects. The intervention will be determined by the consultant Orthopedic Surgeon in clinic.Units of measure:measured in Nm/kg

  up to12 weeks

• Are there gait (kinematic) differences pre and post intervention in toe walking cerebral palsy subjects?

  Kinematics (joint angles) will be measured (using gait analysis modality) pre and post intervention in toe walking cerebral palsy subjects. The intervention will be determined by the consultant Orthopedic Surgeon in clinic.Units of measure: measured in degrees (angle).

  up to 12 weeks

• Triceps Surae muscle activation during the gait cycle (Electromyography)

  Electromyography (EMG) measurement - is the muscle activated or deactivated pre and post intervention in toe walking cerebral palsy subjects? Measured in uV

  up to12 weeks

• Are there morphological differences in the calf muscle pre and post serial casting/botulinum toxin-A intervention in toe walking cerebral palsy subjects?

  B-mode ultrasound modality will be used pre and post intervention to measure muscle morphology parameter - muscle thickness. Measured in millimeter

  up to 12 weeks

• Are there morphological differences in the calf muscle pre and post serial casting/botulinum toxin-A intervention in toe walking cerebral palsy subjects?

  B-mode ultrasound modality will be used pre and post intervention to measure muscle morphology parameter - muscle fibre length; measured in millimeter

  up to 12 weeks

• Are there morphological differences in the calf muscle pre and post serial casting/botulinum toxin-A intervention in toe walking cerebral palsy subjects?

  B-mode ultrasound modality will be used pre and post intervention to measure muscle morphology parameter - muscle length; measured in millimeter

  up to 12 weeks

• Are there morphological differences in the calf muscle pre and post serial casting/botulinum toxin-A intervention in toe walking cerebral palsy subjects?

  B-mode ultrasound modality will be used pre and post intervention to measure muscle morphology parameter - pennation angle; measured in degrees.

  up to 12 weeks

• Are there morphological differences in the calf muscle pre and post serial casting/botulinum toxin-A intervention in toe walking cerebral palsy subjects?

  B-mode ultrasound modality will be used pre and post intervention to measure muscle morphology parameter - Cross sectional area; measured in cm\^2

  up to 12 weeks

• Difference in the muscle stiffness values (using elastography) in the calf muscle pre and post intervention.

  To determine, using elastography modality, if there is a difference in muscle stiffness values pre and post intervention for toe walking cerebral palsy children. Units of measure: m/s velocity

  up to 12 weeks

Other Outcomes (4)

• Are there gait (kinetic and kinematic) differences pre and post intervention in toe walking cerebral palsy subjects?

  up to 12 weeks

• Are there gait (kinetic and kinematic) differences pre and post intervention in toe walking cerebral palsy subjects?

  up to 12 weeks

• Are there gait (kinetic and kinematic) differences pre and post intervention in toe walking cerebral palsy subjects?

  up to 12 weeks

Study Arms (2)

Botulinum Toxin-A injection treatment

Toe walking Cerebral Palsy subject who are subject to Botulinum toxin-A injection treatment. The dosage will be determined by the Orthopaedic Consultant

Drug: Botulinum Toxin-A injection

Serial casting stretching treatment

Toe walking Cerebral Palsy subject who are subject to serial casting stretching treatment.

Procedure: Serial casting stretching

Interventions

Botulinum Toxin-A injection DRUG

Botulinum Toxin-A injection to be administered by the surgeon to the subject's calf muscle as per normal clinical protocol to help improve muscle tone.

Also known as: "Botox"

Botulinum Toxin-A injection treatment

Serial casting stretching PROCEDURE

Stretching cast intervention to be carried out in clinic as per normal clinical protocol.

Also known as: serial cast

Serial casting stretching treatment

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be screened by the research team at weekly review meeting (involving the Medical Director and orthopaedic consultants). Participants will be identified in the Childrens outpatient's clinics at Trust Hospital (RJAH).

You may qualify if:

• Participants must be diagnosed with Cerebral Palsy and have a planned intervention of serial casting or botulinum toxin calf injection or serial casting and botulinum toxin injection.
• Participants must be able to walk 10 metres barefoot.
• Participants must be between the ages of 4 and 16.
• Participants must have a gait pattern showing persistent toe walking or premature heel rise.
• Participants should be able to comply with requests to walk in the gait laboratory.

You may not qualify if:

• Participants who have had Botulinum toxin-A calf injections or previous serial casting within the last 6 months.
• Participants should not have fixed foot equinus.
• Participants must not have any learning difficulties which would prevent compliance with the standard protocols.
• Participants must not have had any previous surgical interventions of the lower limbs within one year of taking of taking part.

Sponsors & Collaborators

• Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust: lead

Study Sites (1)

ORLAU, RJAH Orthopaedic Hospital

Oswestry, Shropshire, SY10 7AG, United Kingdom

RECRUITING

Related Publications (5)

• Armand S, Decoulon G, Bonnefoy-Mazure A. Gait analysis in children with cerebral palsy. EFORT Open Rev. 2016 Dec 22;1(12):448-460. doi: 10.1302/2058-5241.1.000052. eCollection 2016 Dec.

  PMID: 28698802 BACKGROUND

• Barber L, Barrett R, Lichtwark G. Passive muscle mechanical properties of the medial gastrocnemius in young adults with spastic cerebral palsy. J Biomech. 2011 Sep 2;44(13):2496-500. doi: 10.1016/j.jbiomech.2011.06.008. Epub 2011 Jul 16.

  PMID: 21762920 BACKGROUND

• Blemker SS, Asakawa DS, Gold GE, Delp SL. Image-based musculoskeletal modeling: applications, advances, and future opportunities. J Magn Reson Imaging. 2007 Feb;25(2):441-51. doi: 10.1002/jmri.20805.

  PMID: 17260405 BACKGROUND

• Stewart C, Shortland AP. The biomechanics of pathological gait - from muscle to movement. Acta Bioeng Biomech. 2010;12(3):3-12.

  PMID: 21247058 BACKGROUND

• Kalsi G, Fry NR, Shortland AP. Gastrocnemius muscle-tendon interaction during walking in typically-developing adults and children, and in children with spastic cerebral palsy. J Biomech. 2016 Oct 3;49(14):3194-3199. doi: 10.1016/j.jbiomech.2016.07.038. Epub 2016 Aug 8.

  PMID: 27545082 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Botulinum Toxins, Type A

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: March 2, 2020
• Study Start: March 14, 2018
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 11, 2022

Record last verified: 2022-02

Locations

GB (1)