Radial Shockwave for Spasticity in Children With CP or ABI

Gymna Uniphy

Status: Completed

Conditions: Spasticity Post-Traumatic Brain Injury; Spasticity Due to Cerebral Palsy

Treatments: Other: Conventional treatment; Device: radial Extracorporeal shockwave therapy (rESWT)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06909838

S68824

Details and patient eligibility

About

The goal of this clinical trial is to determine if radial Extracorporeal shockwave therapy (rESWT) reduces spasticity in children with Cerbral Palsy (CP) or traumatic brain injury (TBI). The main questions it aims to answer are:

• Is it feasible to implement radial shockwave therapy in conventional physiotherapy plan in children with CP or TBI?
• Is it safe and effective to use rESWT for reducing spasticity in children with CP or TBI? Participants will receive a 4 week therapy intervention, as add on to the conventional physio (usual care), including one rESWT session per week for a total of 4 sessions.

Enrollment: 24 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• cerebral palsy or acquired brain injury
• between 6-18 years old;
• gross motor function classification ≥2;
• experiencing spasticity in the lower limb (calf muscles, hip adductor muscles or hamstring muscles) and/or in the upper limb (biceps muscle, wrist flexor muscles, finger flexor muscles) with Modified Ashworth Scores (MAS) ≥1+.

Exclusion criteria

• recent (≤3 months) Botox injections or other recent (≤6 months) invasive intervention;
• local infections or wounds; neuropathy;
• severe organ dysfunction;
• severe psychosocial dysfunction that would not allow adhering to protocol;
• planned changes in medication dosage or medication scheme that might affect spasticity during a 4-month intervention and follow-up phase.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

24 participants in 2 patient groups

Usual care

Active Comparator group

Description:

Conventional physiotherapy plan

Treatment:

Other: Conventional treatment

Shockwave and usual care

Experimental group

Description:

All participants receive a 4-week rESWT intervention plan (4 sessions with a one week interval), as add-on to the conventional physiotherapy plan

Treatment:

Device: radial Extracorporeal shockwave therapy (rESWT)

Other: Conventional treatment