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Efficacy of Extracorporeal Shock Wave Therapy in Children With Cerebral Palsy

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06128616
Enrollment
40
Registered
2023-11-13
Start date
2023-11-30
Completion date
2024-09-30
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spasticity/Paresis, Cerebral Palsy

Keywords

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

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.

Interventions

DEVICEESWT

Extracorporeal Shock Wave Therapy

DRUGBotulinum Toxin Type A

Botulinum Toxin Type A

Serial Casting

BEHAVIORALPhysical Therapy

Physical Therapy

BEHAVIORALOccupational Therapy

Occupational Therapy

Sponsors

Kocaeli University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean change from baseline Tardieu XV3 anglePost-treatment weeks 4-6Spasticity measurement
Mean change from baseline passive range of movementPost-treatment weeks 12-20Soft tissue contracture measurement

Secondary

MeasureTime frameDescription
Goal Attainment Scale-LightPost-treatment weeks 4-12-20Attainment of treatment goals 5 point scale ranging from -2 to 2, higher score representing better outcome
Faces Pain ScalePost-treatment weeks 4-12-20Assessment of pain by a visual 6 point scale ranging from 0 to 10, 0 representing no pain, 10 representing most excruciating pain

Contacts

Primary ContactNigar Dursun, MD
nigard@hotmail.com90 5334322568
Backup ContactTugba Gokbel, MD
tugbagokbelftr@gmail.com905442877390

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026