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Efficacy of Extracorporeal Shock Wave Therapy in Children With Cerebral Palsy

NCT06128616 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-11-18

No results posted yet for this study

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

Interventions

DEVICE

ESWT

Extracorporeal Shock Wave Therapy

DRUG

Botulinum Toxin Type A

Botulinum Toxin Type A

OTHER

Serial Casting

Serial Casting

BEHAVIORAL

Physical Therapy

Physical Therapy

BEHAVIORAL

Occupational Therapy

Occupational Therapy

Sponsors & Collaborators

  • Kocaeli University

    lead OTHER

Principal Investigators

  • Nigar Dursun, MD · Kocaeli Universitesi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2024-06-30
Completion
2024-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06128616 on ClinicalTrials.gov