Efficacy of Extracorporeal Shock Wave Therapy in Children With Cerebral Palsy

November 15, 2023 updated by: Nigar Dursun, Kocaeli University

Efficacy of Extracorporeal Shock Wave Therapy Integrated to Combined Treatment of Botulinum Toxin A and Serial Casting in Children With Cerebral Palsy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESWT Group
Patients treated by BoNT-A, intermittent SC and ESWT, whom received either PT or OT
Drug: Botulinum Toxin Type A
Botulinum Toxin Type A
Other Names:
  • Botox
Device: ESWT
Extracorporeal Shock Wave Therapy
Other: Serial Casting
Serial Casting
Behavioral: Physical Therapy
Physical Therapy
Behavioral: Occupational Therapy
Occupational Therapy
Active Comparator: Control Group
Patients treated by BoNT-A, and intermittent SC, whom received either PT or OT
Drug: Botulinum Toxin Type A
Botulinum Toxin Type A
Other Names:
  • Botox
Other: Serial Casting
Serial Casting
Behavioral: Physical Therapy
Physical Therapy
Behavioral: Occupational Therapy
Occupational Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline Tardieu XV3 angle
Time Frame: Post-treatment weeks 4-6
Spasticity measurement
Post-treatment weeks 4-6
Mean change from baseline passive range of movement
Time Frame: Post-treatment weeks 12-20
Soft tissue contracture measurement
Post-treatment weeks 12-20

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Goal Attainment Scale-Light
Time Frame: Post-treatment weeks 4-12-20
Attainment of treatment goals 5 point scale ranging from -2 to 2, higher score representing better outcome
Post-treatment weeks 4-12-20
Faces Pain Scale
Time Frame: Post-treatment weeks 4-12-20
Assessment of pain by a visual 6 point scale ranging from 0 to 10, 0 representing no pain, 10 representing most excruciating pain
Post-treatment weeks 4-12-20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Investigators

  • Principal Investigator: Nigar Dursun, MD, Kocaeli Üniversitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

November 8, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAEK/16.bI.06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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