Shock Wave Therapy for Management of Spasticity in Patients With Cerebral Palsy

Study Overview
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Brief Summary
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Spasticity is the most common motor disorder in cerebral palsy (CP). The objectives of his therapeutic approach include; reducing pain, ease of use of orthopedic aids, improving posture, minimizing contractures and deformity, and facilitating mobility and dexterity, with the ultimate goal of maximizing the potential of the patient and promoting their independence and quality of life. The approach to spasticity in CP is complex and presents itself as a great challenge for the rehabilitation team. Radial extracorporeal shock wave therapy (rESWT) has been established in recent years as an effective, non-invasive alternative with hardly any side effects (small bruises or discomfort during the application) for the management of spasticity in patients with CP. rESWT is a relatively new therapy in the field of neurology, in 2010 was published the first clinical trial where shock waves were applied for the management of spasticity in patients with CP. Currently, few works have studied the efficacy of rESWT in patients with CP. In all of them, the results demonstrated the treatment's effectiveness in reducing spasticity locally in people with CP up to 3 months after the application. The group most studied muscle has been the Triceps Surae, and there is a great disparity regarding the doses of treatment applied in each study, especially regarding the number of sessions and the time interval between sessions. The most widely used protocol is 3 rESWT sessions with a time interval of 1 week between session; This protocol was established as the most effective in the treatment of trauma pathology. Despite all the variability in the administration of the dose, we have been able to observe that none of them has studied the effect of rESWT by lengthening the time interval between sessions beyond one week to check whether the therapeutic effects on spasticity can be prolonged over time by applying the same dose. Most of the studies conclude that future research should be aimed at studying the most optimal dose of treatment as well as evaluating the long-term results.

Official Title
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Radial Extracorporeal Shock Wave Therapy for Management of Spasticity in Patients With Cerebral Palsy

Conditions
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Cerebral Palsy, Spasticity, Muscle, Extracorporeal Shock Wave Therapy

Intervention / Treatment
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* Other: Radial extracorporeal shock wave therapy (rESWT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with CP. With a CP classified as spastic. Spasticity in the Triceps Surae muscle. Who have a Gross Motor Classification (GMFCS) level between l and ll Having signed the informed consent by the participant or your legal guardian Exclusion Criteria: Have received treatment with shock waves in the Triceps Surae or any other muscle of the lower extremity in the 6 months before the study. Have received treatment with botulinum toxin and/or treatment focal intramuscular injection with phenol or alcohol in the Triceps Surae or some other lower extremity muscle in the 6 months before the study. Patients who have undergone surgery for deformities foot orthotics in the last year. Fixed deformities in the ankle joint. Clinical signs of myopathy and neuropathy. Infection or tumor at the site of application of the therapy*. Severe blood dyscrasia*. Blood coagulation disorders*. Treatment with oral anticoagulants* Contraindications of radial extracorporeal shock wave therapy.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>3 rESWT sessions with a time interval of 1 week between each session. | Other: Radial extracorporeal shock wave therapy (rESWT)<br>* Radial shock waves are ballistic waves generated by injection of compressed air inside an applicator that fires a projectile into the itself and impacts against the application head<br>|
| Experimental: Experimental Group A<br>3 rESTW sessions with a time interval of 2 weeks between each session. | Other: Radial extracorporeal shock wave therapy (rESWT)<br>* Radial shock waves are ballistic waves generated by injection of compressed air inside an applicator that fires a projectile into the itself and impacts against the application head<br>|
| Experimental: Experimental Group B<br>3 rESTW sessions with a time interval of 4 weeks between each session. | Other: Radial extracorporeal shock wave therapy (rESWT)<br>* Radial shock waves are ballistic waves generated by injection of compressed air inside an applicator that fires a projectile into the itself and impacts against the application head<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in passive range of movement and the stretching reflex in ankle dorsiflexion. Tardieu Scale | Assess the change in degrees of passive range of motion and the ankle dorsiflexion stretch reflex measured with an inclinometer | Base line,3,5,9,12 and 24 weeks | 
| Change in goal attainment scale (GAS) | Goal attainment scale: Definition of an individual goal at the start. Will be assess the achievement or not of an objective and evaluates the expectations of improvement in each of the goals with a numerical scale from -2 to +2: (-2) Result much lower than expected (-1) Lower than expected result (0) Expected result (+1) Result higher than expected (+2) Result much higher than expected | Setting of goal(s) at start (base line), assesment al 3,5,9,12 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain secondary to spasticity assessed by the visual analog scale | If the patient presents pain secondary to spasticity, evaluate the degree of improvement after therapy using the visual analog scale where the value 0 is no pain and 10 is the worst possible pain. | Base line,3,5,9,12 and 24 weeks | 
| Satisfaction with the therapy assessed by the visual analog scale | Evaluate the degree of improvement perceived by the patient in relation to the therapy using the visual analog scale where the value 0 is no perceived improvement and 10 is the maximum expected improvement | Base line,3,5,9,12 and 24 weeks | 
| Adverse effects by Data collection notebook | Possible adverse effects secondary to treatment such as small bruises, petechiae, or muscle fatigue will be recorded in the data collection notebook | Base line,3,5,9,12 and 24 weeks |