Spastic Quadriplegia, Cerebral Palsy (CP), Gastrocnemius Muscle
Conditions
Keywords
spastic quadriplegic cerebral palsy, gastrocnemius muscle spasticity, focused ESWT, radial ESWT
Brief summary
The goal of this pilot randomized controlled trial is to compare the effectiveness of focused extracorporeal shockwave therapy (ESWT) versus radial ESWT on gastrocnemius spasticity in children with spastic quadriplegic cerebral palsy (CP). The main questions it aims to answer are: 1. Does focused ESWT (fESWT) reduce gastrocnemius spasticity more effectively than radial ESWT (rESWT)? 2. Are the antispastic effects of fESWT more durable over time compared with rESWT? Researchers will compare: * fESWT group (one session weekly, 4 weeks) * rESWT group (one session weekly, 4 weeks) to see if fESWT more effective to lower Modified Ashworth Scale (MAS) scores during all assessment time points compared with rESWT. Participants will: * Be randomly assigned to either fESWT or rESWT group. * Receive one treatment session per week for 4 consecutive weeks. * Undergo MAS score evaluations at: baseline, post-intervention weeks 1-4, and follow-up at 4, 8, and 12 weeks after the final treatment.
Detailed description
Dosing parameter is identical in both groups: 1,500 shocks, 2 bar, 6 Hz, medium energy intensity.
Interventions
Focused ESWT (fESWT) generates true acoustic shockwaves that converge at a defined focal point within deeper tissue. Dosing parameters: total impulses 1,500 shocks per session; 2 bar pressure; 6 Hz frequency; medium energy intensity; once weekly for four consecutive weeks. Treatment area: gastrocnemius muscle bellies, including both medial and lateral heads, applied using a sweeping technique from the gastrocnemius down to the soleus. Patient position: prone with the knee extended and the ankle in the patient's comfortable position.
Radial ESWT (rESWT) uses pneumatic acceleration of a projectile that produces pressure waves diverging from the applicator tip, with maximal energy at the skin surface and progressively decreasing energy with depth. Dosing parameters: 1,500 shocks per session; 2 bar pressure; 6 Hz frequency; medium energy intensity; once weekly for four consecutive weeks. Treatment area: gastrocnemius muscle bellies, including both medial and lateral heads, applied using a sweeping technique from the gastrocnemius down to the soleus. Patient position: prone with the knee extended and the ankle in the patient's comfortable position.
Sponsors
Dr Cipto Mangunkusumo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children diagnosed with Spastic Quadriplegic Cerebral Palsy by a pediatrician or pediatric neurologist; * Modified Ashworth Scale (MAS) score of ≥1 at the gastrocnemius muscle * No fixed contracture of the affected skeletal muscles; * Parents or legal guardians who provided written informed consent after receiving education about the fESWT and rESWT procedures and their associated risks.
Exclusion criteria
* Parents or caregivers who were unable to cooperate during clinical assessments; * Parents or caregivers who were unwilling to participate in the study; * Children who were acutely ill at the time of intervention (e.g., with cough, fever, or upper respiratory tract infection); * Children who had received botulinum toxin type A injection within the past 6 months; * Children who had undergone lower limb surgery within the past 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Modified Ashworth Scale (MAS) score of the gastrocnemius muscle | The primary outcome was evaluated at baseline, post-intervention weeks 1 to 4, and follow-up at 4, 8, and 12 weeks post-final treatment by blinded outcome assessor. | The primary outcome was the Modified Ashworth Scale (MAS) score of the gastrocnemius muscle, recorded as an ordinal score on a 6-point scale (0, 1, 1.5, 2, 3, and 4), measuring resistance to passive stretch. |
Countries
Indonesia
Contacts
PRINCIPAL_INVESTIGATORRizky K Wardhani, Dr
Faculty of Medicine, Universitas Indonesia - Cipto Mangunkusumo Hospital
Outcome results
None listed