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

NCT ID: NCT05702606

Last Updated: 2023-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-10
• Study Completion Date: 2022-10-03

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.

Conditions

Cerebral Palsy; Spasticity, Muscle; Extracorporeal Shock Wave Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

3 rESWT sessions with a time interval of 1 week between each session.

Group Type: ACTIVE_COMPARATOR

Radial extracorporeal shock wave therapy (rESWT)

Intervention Type: OTHER

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

Experimental Group A

3 rESTW sessions with a time interval of 2 weeks between each session.

Group Type: EXPERIMENTAL

Radial extracorporeal shock wave therapy (rESWT)

Intervention Type: OTHER

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

Experimental Group B

3 rESTW sessions with a time interval of 4 weeks between each session.

Group Type: EXPERIMENTAL

Radial extracorporeal shock wave therapy (rESWT)

Intervention Type: OTHER

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

Interventions

Radial extracorporeal shock wave therapy (rESWT)

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacio Aspace Catalunya

OTHER

Sponsor Role: lead

Responsible Party

Míriam Tur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Míriam Tur Segura, First

Role: PRINCIPAL_INVESTIGATOR

Fundació Aspace Catalunya

Raimon Milà Villarroel, third

Role: STUDY_DIRECTOR

Facultat de Ciències de la Salut Blanquerna - Universitat Ramon Llull

Locations

Fundació Aspace Catalunya

Barcelona, , Spain

Countries

Spain

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Other Identifiers

ASP_Shock_MT

Identifier Type: -

Identifier Source: org_study_id