Efficacy of Extracorporeal Shock Wave Therapy in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Paralysis
• Paresis

• NCT number: NCT06128616
• Study type: Interventional
• Source: Kocaeli University
• Contact: Nigar Dursun, MD
• Phone: 90 5334322568
• Email: nigard@hotmail.com
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: November 2023
• Completion date: September 2024