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Completed

NCT Number: NCT05702606

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Extracorporeal Shock Wave Therapy Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasticity, Muscle

Age range

4 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundació Aspace Catalunya

Barcelona, 08038, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radial extracorporeal shock wave therapy (rESWT)

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Fundacio Aspace Catalunya

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2023
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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