Efficacy of Extracorporeal Shock Wave Therapy in Children With Cerebral Palsy

NCT ID: NCT06128616

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2024-09-30

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.

Detailed Description

Spasticity is one of the most common motor disorder which may slowly cause soft tissue contractures in children with CP. Spastic plantar and palmar flexion deformities are very common in children with 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. PT, OT, SC, and BoNT-A injections had shown positive results in both of these deformities. Skin irritation or breakdown, painful episodes, oedema, tendonitis, weakness, stiffness are some of the side effects reported after SC. Moreover casting especially when prolonged might complicate activities of daily living for instance by increasing the risk of falls or causing problems in bathing. Recent evidence from literature favors early, goal oriented, activity based, intensive, repetitive motor trainings in enriched environments to optimize neuroplasticity in children with CP. Prolonged SC might also interfere with these activity based, intensive rehabilitation options for upper extremity. In order to overcome the issues with patient compliance, side effects and combined treatment options an intermittent SC model was developed and used both for children with CP presenting equines foot deformity or palmar flexion deformity. Combined management of intermittent SC, and BoNT-A injections had shown better results compared to either treatment alone in both of these deformities. Recent systematic reviews and meta-analyses showed that 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 complementary 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ESWT Group

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

Group Type: EXPERIMENTAL

ESWT

Intervention Type: DEVICE

Extracorporeal Shock Wave Therapy

Botulinum Toxin Type A

Intervention Type: DRUG

Botulinum Toxin Type A

Serial Casting

Intervention Type: OTHER

Serial Casting

Physical Therapy

Intervention Type: BEHAVIORAL

Physical Therapy

Occupational Therapy

Intervention Type: BEHAVIORAL

Occupational Therapy

Control Group

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

Group Type: ACTIVE_COMPARATOR

Botulinum Toxin Type A

Intervention Type: DRUG

Botulinum Toxin Type A

Serial Casting

Intervention Type: OTHER

Serial Casting

Physical Therapy

Intervention Type: BEHAVIORAL

Physical Therapy

Occupational Therapy

Intervention Type: BEHAVIORAL

Occupational Therapy

Interventions

ESWT

Extracorporeal Shock Wave Therapy

Intervention Type: DEVICE

Botulinum Toxin Type A

Botulinum Toxin Type A

Intervention Type: DRUG

Serial Casting

Serial Casting

Intervention Type: OTHER

Physical Therapy

Physical Therapy

Intervention Type: BEHAVIORAL

Occupational Therapy

Occupational Therapy

Intervention Type: BEHAVIORAL

Other Intervention Names

Botox

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Nigar Dursun

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nigar Dursun, MD

Role: PRINCIPAL_INVESTIGATOR

Kocaeli Universitesi

Central Contacts

Nigar Dursun, MD

Role: CONTACT

nigard@hotmail.com

90 5334322568

Tugba Gokbel, MD

Role: CONTACT

tugbagokbelftr@gmail.com

905442877390

References

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Reference Type: RESULT

PMID: 36306168 (View on PubMed)

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.

Reference Type: RESULT

PMID: 33483965 (View on PubMed)

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Reference Type: RESULT

PMID: 33206382 (View on PubMed)

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.

Reference Type: RESULT

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Reference Type: RESULT

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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.

Reference Type: RESULT

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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.

Reference Type: RESULT

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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.

Reference Type: RESULT

PMID: 35412036 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34828772 (View on PubMed)

Other Identifiers

KAEK/16.bI.06

Identifier Type: -

Identifier Source: org_study_id