Clinical trial NCT05702606: Shock Wave Therapy for Management of Spasticity in Patients With Cerebral Palsy
Official title: Radial Extracorporeal Shock Wave Therapy for Management of Spasticity in Patients With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Spasticity, Muscle
Extracorporeal Shock Wave Therapy
Lead sponsor: Fundacio Aspace Catalunya
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 73
Sex: ALL
Minimum age (years): 4
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in passive range of movement and the stretching reflex in ankle dorsiflexion. Tardieu Scale
timeFrame: Base line,3,5,9,12 and 24 weeks
measure: Change in goal attainment scale (GAS)
timeFrame: Setting of goal(s) at start (base line), assesment al 3,5,9,12 and 24 weeks
Secondary outcomes:
measure: Pain secondary to spasticity assessed by the visual analog scale
timeFrame: Base line,3,5,9,12 and 24 weeks
measure: Satisfaction with the therapy assessed by the visual analog scale
timeFrame: Base line,3,5,9,12 and 24 weeks
measure: Adverse effects by Data collection notebook
timeFrame: Base line,3,5,9,12 and 24 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundació Aspace Catalunya
Study officials:
affiliation: Fundació Aspace Catalunya
name: Míriam Tur Segura, First
role: PRINCIPAL_INVESTIGATOR
affiliation: Facultat de Ciències de la Salut Blanquerna - Universitat Ramon Llull
name: Raimon Milà Villarroel, third
role: STUDY_DIRECTOR
References:
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