Efficacy of Extracorporeal Shock Wave Therapy in Children With Cerebral Palsy

NCT06128616 | Unknown Phase 3 DMC

• 1 other identifier: KAEK/16.bI.06
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Spastic plantar and palmar flexion deformities are very common in children with cerebral palsy (CP). These deformities usually involve spasticity of the plantar or palmar muscle complexes, weakness of the antagonist dorsiflexor muscles of the ankle or wrist, and also involve soft tissue/muscle contractures and require a multimodal treatment approach. Physical therapy (PT), occupational therapy (OT), serial casting (SC), and botulinum toxin A (BoNT-A) injections had shown positive results in both of these deformities. Recent systematic reviews and meta-analyses showed that extracorporeal shock wave therapy (ESWT) is effective in reducing spasticity, pain intensity, and increasing range of motion and motor function when combined with PT or BoNT-A injections in neurological conditions like stroke, CP, multiple sclerosis. ESWT can be a complimentary therapy to obtain an earlier efficacy, better efficacy, a sustained effect for a longer period, and less adverse events. The objective of this study was to show the effects of ESWT when combined with intermittent SC, BoNT-A injections and PT or OT on spasticity, passive range of motion (pROM) of children with CP having spastic equinus foot deformity or wrist palmar flexion deformity.

Conditions

Spasticity/Paresis; Cerebral Palsy

Keywords

Spasticity; Cerebral Palsy; Botulinum toxin A; Extracorporeal Shock Wave Therapy; Casting

Outcome Measures

Primary Outcomes (2)

• Mean change from baseline Tardieu XV3 angle

  Spasticity measurement

  Post-treatment weeks 4-6

• Mean change from baseline passive range of movement

  Soft tissue contracture measurement

  Post-treatment weeks 12-20

Secondary Outcomes (2)

• Goal Attainment Scale-Light

  Post-treatment weeks 4-12-20

• Faces Pain Scale

  Post-treatment weeks 4-12-20

Study Arms (2)

ESWT Group

EXPERIMENTAL

Patients treated by BoNT-A, intermittent SC and ESWT, whom received either PT or OT

Device: ESWT; Drug: Botulinum Toxin Type A; Other: Serial Casting; Behavioral: Physical Therapy; Behavioral: Occupational Therapy

Control Group

ACTIVE COMPARATOR

Patients treated by BoNT-A, and intermittent SC, whom received either PT or OT

Drug: Botulinum Toxin Type A; Other: Serial Casting; Behavioral: Physical Therapy; Behavioral: Occupational Therapy

Interventions

ESWT DEVICE

Extracorporeal Shock Wave Therapy

ESWT Group

Botulinum Toxin Type A DRUG

Botulinum Toxin Type A

Also known as: Botox

Control Group; ESWT Group

Serial Casting OTHER

Serial Casting

Control Group; ESWT Group

Physical Therapy BEHAVIORAL

Physical Therapy

Control Group; ESWT Group

Occupational Therapy BEHAVIORAL

Occupational Therapy

Control Group; ESWT Group

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Having a diagnosis of CP according to Rosenbaum criteria, presenting plantar or palmar flexion deformity, having a Modified Ashworth Scale score of 3 in plantar or palmar flexor muscle groups, being scheduled for BoNT-A treatment, intermittent serial casting and physical or occupational therapy

You may not qualify if:

• Having cognitive dysfunction, having a history of orthopedic surgery, presenting significant dystonia, having vascular disease, fracture, or dislocation

Sponsors & Collaborators

• Kocaeli University: lead

Related Publications (9)

• Carranza-Del Rio J, Dursun N, Cekmece C, Bonikowski M, Pyrzanowska W, Dabrowski E, Tilton A, Oleszek J, Volteau M, Page S, Shierk A, Delgado MR. Goal Attainment after Treatment with Abobotulinumtoxina and a Tailored Home Therapy Programme in Children with Upper Limb Spasticity: Descriptive, Exploratory Analysis of a Large Randomized, Controlled Study. J Rehabil Med. 2022 Dec 9;54:jrm00349. doi: 10.2340/jrm.v54.2540.

  PMID: 36306168 RESULT

• Dursun N, Gokbel T, Akarsu M, Bonikowski M, Pyrzanowska W, Dursun E. Intermittent serial casting for wrist flexion deformity in children with spastic cerebral palsy: a randomized controlled trial. Dev Med Child Neurol. 2021 Jun;63(6):743-747. doi: 10.1111/dmcn.14765. Epub 2021 Jan 22.

  PMID: 33483965 RESULT

• Delgado MR, Tilton A, Carranza-Del Rio J, Dursun N, Bonikowski M, Aydin R, Maciag-Tymecka I, Oleszek J, Dabrowski E, Grandoulier AS, Picaut P; Dysport in PUL study group. Efficacy and safety of abobotulinumtoxinA for upper limb spasticity in children with cerebral palsy: a randomized repeat-treatment study. Dev Med Child Neurol. 2021 May;63(5):592-600. doi: 10.1111/dmcn.14733. Epub 2020 Nov 18.

  PMID: 33206382 RESULT

• Dursun N, Gokbel T, Akarsu M, Dursun E. Randomized Controlled Trial on Effectiveness of Intermittent Serial Casting on Spastic Equinus Foot in Children with Cerebral Palsy After Botulinum Toxin-A Treatment. Am J Phys Med Rehabil. 2017 Apr;96(4):221-225. doi: 10.1097/PHM.0000000000000627.

  PMID: 27631386 RESULT

• Delgado MR, Tilton A, Russman B, Benavides O, Bonikowski M, Carranza J, Dabrowski E, Dursun N, Gormley M, Jozwiak M, Matthews D, Maciag-Tymecka I, Unlu E, Pham E, Tse A, Picaut P. AbobotulinumtoxinA for Equinus Foot Deformity in Cerebral Palsy: A Randomized Controlled Trial. Pediatrics. 2016 Feb;137(2):e20152830. doi: 10.1542/peds.2015-2830. Epub 2016 Jan 26.

  PMID: 26812925 RESULT

• Dursun N, Bonikowski M, Dabrowski E, Matthews D, Gormley M, Tilton A, Carranza J, Grandoulier AS, Picaut P, Delgado MR. Efficacy of Repeat AbobotulinumtoxinA (Dysport(R)) Injections in Improving Gait in Children with Spastic Cerebral Palsy. Dev Neurorehabil. 2020 Aug;23(6):368-374. doi: 10.1080/17518423.2019.1687602. Epub 2019 Nov 6.

  PMID: 31691605 RESULT

• Chang MC, Choo YJ, Kwak SG, Nam K, Kim SY, Lee HJ, Kwak S. Effectiveness of Extracorporeal Shockwave Therapy on Controlling Spasticity in Cerebral Palsy Patients: A Meta-Analysis of Timing of Outcome Measurement. Children (Basel). 2023 Feb 9;10(2):332. doi: 10.3390/children10020332.

  PMID: 36832460 RESULT

• Mihai EE, Popescu MN, Iliescu AN, Berteanu M. A systematic review on extracorporeal shock wave therapy and botulinum toxin for spasticity treatment: a comparison on efficacy. Eur J Phys Rehabil Med. 2022 Aug;58(4):565-574. doi: 10.23736/S1973-9087.22.07136-2. Epub 2022 Apr 12.

  PMID: 35412036 RESULT

• Kwon DR, Kwon DG. Botulinum Toxin a Injection Combined with Radial Extracorporeal Shock Wave Therapy in Children with Spastic Cerebral Palsy: Shear Wave Sonoelastographic Findings in the Medial Gastrocnemius Muscle, Preliminary Study. Children (Basel). 2021 Nov 17;8(11):1059. doi: 10.3390/children8111059.

  PMID: 34828772 RESULT

MeSH Terms

Conditions

Muscle Spasticity; Paresis; Cerebral Palsy

Interventions

Botulinum Toxins, Type A; Physical Therapy Modalities; Occupational Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central 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; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Nigar Dursun, MD

  Kocaeli Universitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nigar Dursun, MD

CONTACT

90 5334322568; nigard@hotmail.com

Tugba Gokbel, MD

CONTACT

905442877390; tugbagokbelftr@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 13, 2023
• Study Start: November 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share