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

January 26, 2023 updated by: Míriam Tur, Fundacio Aspace Catalunya

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08038
        • Fundació Aspace Catalunya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
3 rESWT sessions with a time interval of 1 week between each session.
Other: 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
Experimental: Experimental Group A
3 rESTW sessions with a time interval of 2 weeks between each session.
Other: 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
Experimental: Experimental Group B
3 rESTW sessions with a time interval of 4 weeks between each session.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in passive range of movement and the stretching reflex in ankle dorsiflexion. Tardieu Scale
Time Frame: Base line,3,5,9,12 and 24 weeks
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)
Time Frame: Setting of goal(s) at start (base line), assesment al 3,5,9,12 and 24 weeks

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
Time Frame: Base line,3,5,9,12 and 24 weeks
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
Time Frame: Base line,3,5,9,12 and 24 weeks
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
Time Frame: Base line,3,5,9,12 and 24 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio Aspace Catalunya

Investigators

  • Principal Investigator: Míriam Tur Segura, First, Fundació Aspace Catalunya
  • Study Director: Raimon Milà Villarroel, third, Facultat de Ciències de la Salut Blanquerna - Universitat Ramon Llull

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2021

Primary Completion (Actual)

October 3, 2022

Study Completion (Actual)

October 3, 2022

Study Registration Dates

First Submitted

November 29, 2022

First Submitted That Met QC Criteria

January 26, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASP_Shock_MT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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